BBB National Programs Archive

 

Philips Oral Healthcare

Philips Sonicare FlexCare and FlexCare+ Toothbrushes

Challenger:                 The Procter & Gamble Company

 — NAD evaluates express statements made by an advertiser and also the accuracy of any messages that can be reasonably conveyed by the advertising.

— “Clinically proven” health claims have a powerful impact on consumers and must be proven by reliable, competent and consumer-relevant scientific evidence. 

— Clinically proven claims are a promise that there is scientific evidence that proves or “establishes” the truth of an advertiser’s claims and literally speaks to the testing of the product in terms of its claimed efficacy.  Therefore, in addition to requiring clinical testing that is grounded in sound methodology that yields consumer relevant results, the advertiser’s claims must also closely reflect the test results upon which they are based.

          — Whether a specific claim falls within puffery’s protective reach is largely                 dependent on whether consumer expectations are created by the claim.

Basis of Inquiry: Product packaging, print, video and internet claims made by Philips Oral Healthcare, Inc. (“the advertiser”) for its Sonicare FlexCare and FlexCare+ toothbrushes were challenged by Procter & Gamble, Inc. (“the challenger”), the manufacturer of Oral-B rotating-oscillating power toothbrushes, including the Oral-B Triumph 9000.[1]  The challenged claims include:

             “Sonicare FlexCare is demonstrated in vitro to remove three times more plaque      biofilm than Oral-B Triumph.”

             Demonstrated in vitro to clean beyond the reach of the bristles.”

             Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B   Triumph.”

The patented sonic technology of FlexCare creates a sweeping motion of the bristles that no other power toothbrush can match for unparalleled cleaning of the teeth and gums.”       Sonicare FlexCare+ combines patented technology and “the most advanced” design available in toothbrushing.

Gentle brushing action helps prevent gum recession” and “Sonicare toothbrushes are clinically proven to reduce . . . gum recession . . .  .”

“Patients brushed significantly longer using Sonicare FlexCare+ in the gum mode than with the Oral-B Triumph with Smart Guide.”

Sonicare FlexCare+ . . . cause[s] 50% less dentin wear . . .” and is “two times    gentler on dentin than Oral-B Triumph.”

            “Sonicare FlexCare+ Is The #1 Recommended Brand By Dental Professionals. 

Challenger’s Position:           

  1. I.          In Vitro Claims
  1.             A.        “Sonicare FlexCare Is Demonstrated In Vitro To Remove Three Times                                More Plaque Biofilm Than Oral-B Triumph.”

    The challenger argued that the claim “Sonicare FlexCare is demonstrated in vitro to remove three times more plaque biofilm than Oral-B Triumph” necessarily implies a clinically meaningful in vivo benefit for which the advertiser has no evidence.  Further, the challenger argued that the Aspiras Study submitted by the advertiser in support of the claim is not consumer relevant because the study did not test the power toothbrushes according to the manufacturers’ instructions.  In the Aspiras Study, plaque-covered discs were placed interproximally at the mandibular molars in an artificial oral cavity.  The Sonicare FlexCare and the Oral-B Triumph toothbrush bristles were kept at a distance of two to four millimeters from the teeth and then activated to expose the cavity to fluid dynamic forces generated by the Sonicare FlexCare or Oral-B Triumph.  The challenger argued that, unlike the Aspiras Study methodology, consumers brush by actually placing the bristles on their teeth and also there was no evidence that the results obtained from a test that employed artificial teeth, salvia and plaque would produce similar results in human mouths.  

    Moreover, the challenger maintained that it had produced three reliable studies demonstrating that, under consumer relevant conditions, the Oral-B Triumph performed either at parity or removed more plaque than the FlexCare power toothbrush.  In A Randomized 12-Week Study to Compare the Gingivitis and Plaque Reduction Benefits of a Rotation-Oscillation Power Toothbrush and a Sonic Power Toothbrush (“Goyal Study”), 171 participants were divided into Oral-B and FlexCare groups and evaluated for plaque reduction after six and twelve weeks of use.  At the end of six weeks, the challenger claimed that the Oral-B Triumph reduced plaque thirty percent better than the Sonicare FlexCare.  At twelve weeks, the Oral-B Triumph group showed a thirty-three percent improvement over the FlexCare group.  In the Study Comparing the Plaque Removal Efficacy of an Advanced Rotation-Oscilltion Power Toothbrush to a New Sonic Toothbrush (“Biesbrock Study”), forty-seven subjects were evaluated in a cross-over study[2] where subjects were evaluated for plaque reduction after a single brushing.  The challenger maintained that the study concluded that Oral-B Triumph reduced plague 12.1 percent better than FlexCare.  The challenger’s third study, A 10-Week Clinical Comparison of the Safety and Efficacy of Two Power Toothbrushes in the Reduction of Plaque and Gingivitis (“Williams Study”), at the end of a four and ten week evaluation of 171 subjects, found that neither power toothbrush performed statistically significantly better at removing plaque than the other. 

  1.             B.        “Demonstrated In Vitro To Clean Beyond The Reach Of The Bristles.”

    While the advertiser also claimed that the Aspiras Study supported the “demonstrated in vitro to clean beyond the reach of the bristles” claim, the challenger submitted an in vivo study that the challenger argued demonstrated that the FlexCare performs no better with respect to plaque removal with its sonic vibrational capabilities engaged or disabled.  The He Study involved 32 participants in an examiner blind, randomized, four period cross-over design.  The two treatment regimens were the Sonicare FlexCare toothbrush with the power on and the Sonicare FlexCare with the power turned off (i.e., like a manual toothbrush).  Participants used each treatment two times during the course of the study (with a three to five day acclimation period in between visits).  Plaque was measured with the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) before and after each two-minute brushing treatment.[3]  The He Study concluded that the plaque differences between the regimens (3.5%) was not statistically significant and that therefore the sonic capability of the FlexCare power toothbrush did not improve the toothbrush’s efficacy in removing plaque.  

  1.         Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B   Triumph.”

    The challenger argued that “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph” is an establishment claim requiring a heightened standard of proof.  The challenger maintained that the advertiser’s Schaeken Study and Putt Study do not meet the standard of proof for an establishment claim because they both measured plaque reduction after only one brushing.[4]  The challenger further argued that its contradictory Goyal and Williams studies are more reliable than the Schaeken and Putt studies because they measured the plaque reduction of a larger number of respondents over several weeks of brushing.  The challenger further argued that its single use study, the Biesbrock Study, also demonstrated that the Oral-B Triumph removed more twelve percent more plaque than the FlexCare.

    In response to the advertiser’s criticism that the Goyal Study demonstrates only that the Oral-B group started and ended the study with less plaque, the challenger responded that, in fact, the Oral-B group had slightly more (but not statistically significantly more) plaque (.621 RMNPI) than the FlexCare group (.614 RMNPI).  Yet the subjects in the Oral-B group had the lowest plaque scores at the end of six weeks (.119 RMNPI versus .170 RMNPI) and twelve weeks (.108 RMNPI versus .162 RMNPI).  Thus, the challenger maintained, the advertiser had failed to identify a methodological flaw in the Goyal Study.

    With regard to the Williams Study, the challenger disagreed with the advertiser that it was insufficiently powered to detect a difference with respect to plaque removal between the Oral-B and the FlexCare groups.  For example, with regard to gingivitis, the study did find that the Oral-B Triumph power toothbrush outperformed the FlexCare power toothbrush to a statistically significant degree at four and ten weeks.  The advertiser had also pointed to the highly divergent number of bleeding sites between the FlexCare and Oral-B groups as an indicium of the study’s unreliability.  The challenger rejoined that the groups were balanced at the outset with respect to both plaque and gingivitis scores and that the FlexCare group had many more bleeding sites than the Oral-B group because the Oral-B Triumph is better at reducing this symptom.[5] 

    The challenger further maintained that the advertiser had not identified any methodological flaws in the Biesbrock Study.  The challenger dismissed the advertiser’s argument that the participants’ RMNPI scores were not balanced at baseline.  The challenger noted that TMQHPI scores were balanced at the outset, and that reportable TMQHPI results were obtained and published.  (Both RMNPI and TMQHPI are industry-standard indexes and therefore the TMQHPI scores alone were sufficient).  With regard to the acclimation period, the advertiser criticized the Biesbrock Study because participants acclimated to both toothbrushes between the first and second visits, alternating brushing every two days between the FlexCare and the Oral-B toothbrushes.  The challenger responded that the participants were thoroughly acclimated to both brushes and the advertiser had not put forth any evidence that demonstrated that this acclimation method was insufficient.  Further, the challenger noted that, while the advertiser maintained that to eliminate any carry over effect there should have been more than a forty-eight hour washout period between visits in the Biesbrock Study, the advertiser’s Schaeken and Putt studies did not have washout periods.

    The challenger further rejoined that it is irrelevant whether the easy start function was disabled on the FlexCare because the brush would have ramped up during the acclimation period and thus have no effect on the results. 

  1. The Patented Sonic Technology Of FlexCare Creates A Sweeping Motion Of The Bristles That No Other Power Toothbrush Can Match For Unparalleled Cleaning   Of The Teeth And Gums.”

    The challenger maintained that the claim “the patented sonic technology of FlexCare creates a sweeping motion of the bristles that no other power toothbrush can match for unparalleled cleaning of the teeth and gums” is a comparative superiority claim that is capable of being objectively proven.  Irrespective of the advertiser’s argument to the contrary, “cleaning” is not a vague, undefined term; in typical toothbrush parlance, “cleaning” means the removal of plaque and debris.  The challenger argued that it had produced several studies (i.e., the Goyal, Biesbrock and Williams studies) demonstrating that the Oral-B Triumph removed plaque better than FlexCare. 

  1.        Sonicare FlexCare+ Combines Patented Sonic Technology And “The Most             Advanced” Design Available In Toothbrushing.

    The challenger argued that the claim that Sonicare FlexCare+ technology and design is “the most advanced” is similarly not puffery.  The challenger contended that the fact that it cost the advertiser over ten million dollars to design the FlexCare is not evidence that it has “the most advanced” technology.[6]  The challenger further argued that the a “most advanced” claim is not puffery because it possible to compare toothbrushes on various metrics such as plaque removal, gingivitis reduction, oral malodor reduction and stain removal to determined which toothbrush is the most advanced.  The challenger argued that its studies demonstrate that the Oral-B Triumph is a better performing, more advanced toothbrush.

  1. Gentle Brushing Action Helps Prevent Gum Recession” And “Sonicare     Toothbrushes Are Clinically Proven To Reduce . . . Gum Recession . . .  .”

    The challenger argued that the advertiser’s Holt study, which it submitted to support its gum recession claims, measured gingival inflammation and bleeding of the gums which is not synonymous with gum recession.  Gum recession is characterized by gum tissue thinning and no longer adhering to teeth and may be caused by a variety of factors, including trauma to teeth, aggressive polishing by a dental professional, chronic exposure to bacterial plaque, toothbrush abrasion, abnormal tooth position and periodontal disease.  Gingivitis is a gum infection characterized by gum bleeding and inflammation and is caused by the irritation of gum tissue by acids produced by mouth plaque and infection of the tissue.  Thus, the challenger submitted, the advertiser cannot rely upon the Holt Study to support its gum recession claims because the Holt Study measured gingival inflammation scores. 

  1. VI.       “Patients Brushed Significantly Longer Using Sonicare FlexCare+ In The Gum     Mode Than With The Oral-B Triumph With Smart Guide.”

    The challenger maintained that the study the advertiser submitted in support of the claim that “patients brushed significantly longer using Sonicare FlexCare+ in the gum mode than with the Oral-B Triumph with Smart Guide” is biased because it compared the FlexCare+ toothbrush that was set to alert brushers to stop brushing at three minutes, yet the Oral-B Triumph group, using the Smart Guide, were alerted to change mouth quarter sections every thirty seconds for a total of two minutes.  The challenger argued that the study merely demonstrated that users of a brush with a three minute timed mode are more likely to continue brushing longer than users of a brush in a two minute timed mode because they are not alerted to stop brushing as soon. 

  1. Sonicare FlexCare+ . . . Cause[s] 50% Less Dentin Wear . . .” And Is “Two        Times Gentler On Dentin Than Oral-B Triumph.”

    The challenger argued that the advertiser’s claim that the Sonicare FlexCare+ . . . cause[s] 50% less dentin wear . . .” and is “two times gentler on dentin than Oral-B Triumph” implies that the FlexCare+ is gentler on actual human teeth, which is not supported by the advertiser’s clinical study.  The challenger objected to the advertiser’s reliance on the de Jager Study which examined the wearing effects in vitro of Oral-B and FlexCare brushes on dentin, because in the study the Oral-B power toothbrush was applied on dentin samples with a 150 grams of force to the dentin samples but the FlexCare+ was applied to the samples with ninety grams of force.  The challenger maintained that the study demonstrates that higher application forces causes more wear on artificial gums but it does not support the unqualified claim that “Sonicare FlexCare+ . . . cause[s] 50% less dentin wear . . .” and is “two times gentler on dentin than Oral-B Triumph.” 

    Further, the challenger argued that the advertiser had no reliable support for its contention that consumers typically apply 150 grams of force when using an Oral-B Triumph power toothbrush yet only ninety grams of force when using the Sonicare FlexCare.  The consumer use study the advertiser submitted in support of its position was fifteen years old and did not measure the forces used by either a FlexCare or an Oral-B Triumph; instead it measured the Rotadent, Interplak and Braun/Oral-B electric toothbrushes. 

  1. VIII.    Sonicare FlexCare+ Is The #1 Recommended Brand By Dental Professionals.

    The challenger argued that the advertiser should qualify its claim on its product packaging that “Sonicare FlexCare+ is the #1 recommended brand by dental professionals” to clarify that it is the most recommended brand of power toothbrushes.  The challenger maintained that Oral-B is the most recommended brand of manual toothbrushes.  The challenger argued that the ‘ #1 Recommended Brand By Dental Professionals” on the front of the product packaging does not contain any other qualifying language nor does it have an asterisk to tell consumers to look on the side panel for qualifying language.  The challenger also claimed that the language on the side panel is not immediately visible to consumers when they are looking at the boxes on store shelves. 

    Advertiser’s Position:

    The advertiser explained that the Sonicare FlexCare and FlexCare+ power toothbrushes combine mechanical plaque removal with fluid dynamics generated by high-speed bristle motion (260 Hertz operating frequency).  The advertiser maintained that the sonic capability of its brushes improves interproximal plaque removal through cavitation and bubbles, decreases gingival inflammation and is gentler on gums.[7]  The FlexCare uses a sweeping side-to-side oscillation and the difference between the FlexCare and FlexCare+ is that the FlexCare has a two minute timed modes while the FlexCare + has a three-minute timed mode option. 

  1. I.          In Vitro Claim
  1.             A.        “Sonicare FlexCare Is Demonstrated In Vitro To Remove Three Times                                More Plaque Biofilm Than Oral-B Triumph.”

    The advertiser argued that the challenger did not contest the literal truth of the claim “Sonicare FlexCare is demonstrated in vitro to remove three times more plaque biofilm than Oral B-Triumph.”[8]  The advertiser argued that its claim is properly “qualified, specifically targeted . . . and specifically identified as [based on in vitro testing].”[9]  The advertiser noted that the challenged claim is disseminated solely to dental professionals, a sophisticated audience capable of appreciating the differences between in vitro and in vivo testing.

    In support of its express claim, the advertiser submitted the 2007 Aspiras Study which, in a head-to-head study of Sonicare FlexCare versus Oral-B Triumph, determined that Sonicare FlexCare removed three times more plaque biofilm in vitro.  In the Aspiras Study, discs with plaque biofilm were located between sample molar teeth at a distance of approximately two to four millimeters from the bristles and exposed to fluid dynamic activity generated by an activated Sonicare FlexCare or Oral-B Triumph.  An inactive Sonicare FlexCare was utilized as a control.  The bristles never touched the biofilm samples.  According to the study results, the Sonicare FlexCare toothbrush removed 73.3% of the biofilm on the discs, the Oral-B Triumph removed 22.8% of the biofilm and the control toothbrush removed .5% of the biofilm.  Thus, according to the advertiser, the Aspiras Study demonstrates that the Sonicare FlexCare toothbrush is 3.2 times more effective at removing plaque in vitro that the Oral-B Triumph toothbrush.[10]

  1.             B.        “Demonstrated In Vitro To Clean Beyond The Reach Of The Bristles.”

    The advertiser relied on the 2007 Aspiras Study to also support the claim that FlexCare is “demonstrated in vitro to clean beyond the reach of the bristles.”[11] 

    With respect to the challenger’s contradictory evidence, “A Study To Assess Plaque Removal Efficacy Of A Marketed Toothbrush,” (“He Study”) the advertiser asserted that a flaw in the methodology rendered the results irrelevant and unreliable.  The He Study measured the subjects’ during four visits, two in which they brushed with Sonicare FlexCare toothbrush powered on and two in which they brushed with the Sonicare FlexCare toothbrush powered off.  The advertiser argued that the FlexCare is designed to be used with the power on and therefore the results from the He Study are meaningless.

  1. Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B   Triumph.”       

    In support of its claim that “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph,” the advertiser submitted two studies — A Randomized, Single Use Study to Compare Plaque Removal Ability of Sonicare FlexCare and Oral-B Triumph Professional Care 9000 (“Schaeken Study”) and A Randomized Cross-Over-Design Study to Investigate the Plaque Removal Ability of Two Power Toothbrushes (“Putt Study”).  The Schaeken Study, which was a two-week, examiner-blind study with ninety-one subjects, concluded that the FlexCare toothbrush removed statistically-significantly (6.34%) more plaque than the Oral-B Triumph 9000.  The Putt Study, similarly a single-blind and randomized with ninety-three participants, also concluded that the FlexCare toothbrush removed statistically-significant (7.59%) more plaque that the Oral-B Triumph 9000.

    The advertiser maintained that the challenger’s sole objection to Schaeken and Putt studies is that they are single use studies, i.e., studies in which plaque reduction is measured after one brushing.  In response, the advertiser argued that single use studies are prevalent in the dental industry to substantiate plaque reduction claims, as opposed to long term use studies which are more relevant in studying gum disease.[12]  In response to the challenger’s Goyal, Biesbrock and Williams studies that the challenger claimed demonstrate that Oral-B toothbrushes are more effective at removing plaque than FlexCare+, the advertiser rejoined that these studies are not more reliable than the Schaeken and Putt studies.  First, the challenger argued that the underlying data of the twelve-week long Goyal Study does not support the conclusion that at six weeks the Oral-B toothbrush group had reduced plaque thirty percent better than the Sonicare group.  The advertiser maintained that the thirty percent difference was a clinically meaningless measure because it focused in the overall post-brushing plaque scores when it should have focused in plaque reduction.  The advertiser argued that the FlexCare group outperformed Oral-B Triumph at week six and, at week twelve and there was no statistically significant difference between the two groups.[13]

    The advertiser, turning to the Biesbrock Study, argued that the failure to report all of the data collected during the course of the study was a fatal flaw that rendered the results to be insufficiently reliable to overcome the advertiser’s demonstrated reasonable basis for its claim that “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph.”  In the Biesbrock Study, the abstract noted that examiners measured the subjects’ plaque using both the Turesky Modification of the Quigley Hein Plaque Index (TMQHPI) and also the Rustogi Modification of the Navy Plaque Index (RMNPI).  However, for visits three, four and five, the RMNPI values were collected but apparently discarded and not utilized in the study.  The advertiser also contended that the Biesbrock Study was unreliable because it incorrectly acclimated participants to the power toothbrushes by alternating usage between the two toothbrush every two days for a week; the study was silent as to whether it excluded potential participants who already used power toothbrushes; the wash-out period was insufficient to account for the carry-over effect; and finally, it was unclear whether the “easy start” feature was disabled, which would skew the results because the easy start feature ramps the pressure of the FlexCare brush up over successive uses.

    The Williams’ Study, Comparison of Rotation/Oscillation and Sonic Power Toothbrushes on plaque and Gingivitis for 10 Weeks, expressly concluded that “there was no statistically significant differences between the two brushes [Oral-B Triumph and Sonicare FlexCare+] at Week 4 or Week 10 for post-brushing or pre-brushing plaque scores.” [14]  The advertiser disagreed that the study demonstrated parity between the two brushes; rather, the advertiser argued that the study was not powerful enough to detect a difference.[15] 

  1. The Patented Sonic Technology Of FlexCare Creates A Sweeping Motion Of The Bristles That No Other Power Toothbrush Can Match For Unparalleled Cleaning   Of The Teeth And Gums.”

    In the first instance, the advertiser denies that the claim “the patented sonic technology of FlexCare creates a sweeping motion on the bristles that no other power toothbrush can match for unparalleled cleaning of the teeth and gums” conveys an implied superior plaque removal message.  The advertiser maintained that it is more properly characterized as puffery in that “unparalleled cleaning” is a vague term not capable of being measured.[16]  It is simply a statement of a manufacturer’s pride in its product that is directed toward dental professionals.

    However, the advertiser also argued that it could support a superiority claim if NAD determined that such a message was being conveyed.  The term “unparalleled” in the claim refers to the cleaning that results from the patented technology that creates the sweeping motion of the brush which creates a velocity greater than 1.5 meters per second sufficient to produce a cleansing action with the dentrifice fluid that is beyond the reach of the bristles of the brush.  

  1. IV.       Sonicare FlexCare+ Combines Patented Technology And “The Most Advanced” Design  Available In ToothBrushing.

    The advertiser maintained that claim that FlexCare+ is the “the most advanced” is another example of puffery that is directed solely to dental professionals that does not require substantiation.  However, the advertiser argued that Sonicare FlexCare+ may also fairly be characterized as the most advanced technology in toothbrushing.[17]  For example, the drive train and brush head were redesigned from early models to be lighter and more energy efficient.  Yet another technological advancement is that the internal system of the FlexCare+ recalibrates itself to optimum resonance (sonic) performance each time the brush is turned off ensuring that the sonic/resonant motion of the brush head is maintained over the lifetime of the brush.  Also, the patented “spring” system significantly reduces the vibration in the toothbrush handle for ease of use without sacrificing the effectiveness of the sonic motion of the brush head. 

  1. Gentle Brushing Action Helps Prevent Gum Recession” And “Sonicare Toothbrushes Are Clinically Proven To Reduce . . . Gum Recession . . .  .”

    The advertiser maintained that the claims “gentle brushing action helps prevent gum recession” and “Sonicare toothbrushes are clinically proven to reduce . . . gum recession are primarily made to dental professionals and no claim is made to consumers that Sonicare FlexCare+ is “clinically proven” to prevent gum recession. 

    The advertiser submitted the Holt Study as substantiation for its gum recession claims. [18]  The Holt Study was a four week single blind, randomized clinical trial where the subjects were assigned to two groups: one group brushed twice daily with Sonicare FlexCare+ toothbrushes and the second group brushed twice daily with a manual toothbrush.  The gingival inflammation scores of the FlexCare+ group were reduced by a statistically significant 28.4% and their bleeding scores were lowered by 43.9% over the four-week study.[19]  The advertiser argued that the Holt Study substantiates its gum recession claim because it is axiomatic that gingival inflammation, left unchecked, eventually results in the gums receding.

  1. VI.       “Patients Brushed Significantly Longer Using Sonicare FlexCare+ In The Gum Mode Than With The Oral-B Triumph With Smart Guide.”

    The advertiser argued that the challenger does not dispute that the results of its study, “Duration of Philips Sonicare FlexCare+ Versus Oral-B Triumph with Smart Guide Power, correctly concluded that users of FlexCare+ toothbrushes brushed significantly longer than the Oral-B Triumph toothbrush group.[20]  In the parallel-design, two-week, two-visit study, participants were randomized into a Sonicare or Oral-B power toothbrush group, provided brushing instructions and then timed while they conducted an on-site brushing session.  They used their brushes for two-weeks and returned to be timed again during a second on-site brushing session.  Users of the FlexCare+ Sonicare brushed for thirty-three seconds longer than Oral-B users at the first visit and twenty-five seconds longer during the second visit.  Thus, the advertiser maintained, the study confirms the literal language of the claim.  The advertiser further claimed that its study is consumer relevant and important to dental professionals because it is universally understood amongst dentists that appropriate toothbrushing duration is a key element to good oral care.

  1. Sonicare FlexCare+ . . . Cause[s] 50% less dentin wear . . .” And Is “Two Times Gentler On Dentin Than Oral-B Triumph.”

    The advertiser argued that its study, In Vitro Assessment of Toothbrush Wear on Natural and Restorative Materials (“de Jager Study”) demonstrated that dentin exposed to FlexCare in vitro showed significantly less dentin wear as compared to the Oral-B Triumph and Oral-B manual toothbrush.  The advertiser claimed that an in vitro study is only ethical manner in which to study dentin abrasion because dentin wear is detrimental to oral health and should not be intentionally inflicted. 

    In the de Jager Study, dentin samples were taken from extracted human teeth without caries or restorations in the plane of the section.  The teeth were sectioned to avoid the pulp chambers in the dentin, which was sliced into 2mm x 3mm x 10mm samples.  The brush heads were mounted at the same level as the specimens and weight was added to simulate the consumer relevant brushing forces for a Sonicare, Oral-B and manual toothbrush, which were tested at 90, 150 and 250 grams of force respectively.  With the disparate load forces, the average dentin wear for the FlexCare was 37.8 µm and 80.9 µm for the Oral-B Triumph.

    With regard to the disparate application forces, the advertiser argued that these forces were consumer relevant as demonstrated by a consumer use study.[21]  The de Jager Study, however, also studied dentin wear when 150 grams of pressure were applied on all three brushes and still the FlexCare samples had less dentin wear than the Triumph samples.  Under an equal loading force of 150 grams, the dentin exposed to the FlexCare had 38.6 µm of wear while the Oral-B Triumph dentin experience 80.9 µm of wear.

    The advertiser responded to the challenger’s argument — that dentin wear results are not relevant to most consumers because dentin, in healthy people, is covered by enamel – by pointing out that the challenger had participated in a similar study to support past dentin claims and also that this claim is directed at dental professionals.  Further, an in vitro model is the only ethical way to study dentin wear as it should not be intentionally degraded in human mouths.

  1. VIII.    Sonicare FlexCare+ Is The “#1 Recommended Brand By Dental Professionals.”

    The advertiser maintained that there is no dispute that Sonicare is the number one recommended power toothbrush brand.  (Recent research demonstrates that by the end of 2009 Sonicare power toothbrushes were recommended by dental professionals 50% of the time and Oral-B models 36% of the time).  Despite the challenger’s argument to the contrary, the advertiser submitted that consumers would reasonably understand the claim that “#1 Recommended Brand by Dental Professionals” to be limited to power toothbrush and not all toothbrushes, including manual toothbrushes.[22]  This claim appears only on material for Sonicare’s power toothbrushes.  On the product packaging which carries this claim, also, on the side of the packaging, prominently displays the statement “more dental professionals worldwide recommend Sonicare than any other sonic toothbrush” and “Sonicare is the power toothbrush most often recommended by U.S. dental professionals,” thus further clarifying that the “#1” claim refers to power toothbrushes.

    Decision:

    Both parties manufacture power toothbrushes that are effective at removing plaque and improving oral health.  The toothbrushes employ different mechanisms of action to accomplish these tasks.  The advertiser’s Sonicare FlexCare and FlexCare+ power toothbrushes use a sweeping motion and a high bristle speed motion in the sonic frequency range to remove plaque, while the advertiser’s Oral-B Triumph utilizes a rotating-oscillating design. 

  1. I.          In Vitro Claims
  1.             A.        “Sonicare FlexCare Is Demonstrated In Vitro To Remove Three Times                                More Plaque Biofilm Than Oral-B Triumph.”

    When evaluating the claims and representations made in advertising, NAD not only addresses any express claims made by an advertiser but also the accuracy of any implied messages reasonably conveyed by the advertising.[23]  NAD determined that one reasonably conveyed message from the claim “Sonicare FlexCare is demonstrated in vitro to remove three times more plaque biofilm than Oral-B Triumph when tested according to the manufacturer’s use instructions that the Sonicare FlexCare was superior to the Oral-B Triumph at removing plaque. [24]

    NAD’s inquiry was to consider how well the messages conveyed by the challenged claim were supported by the evidence upon which the advertiser relied in support of its claims.  The purpose of the advertiser’s Aspiras Study was to evaluate the ability of fluid-induced forces generated by power toothbrushes to remove dental plaque biofilm from interproximal surfaces beyond the reach of the bristle.  Either an Oral-B or a FlexCare power toothbrush was placed in a typodont (a model of an oral cavity) that had plaque biofilm-coated discs placed interproximally at the mandibular molars.  The exposure chamber contained seven milliliters of phosphate-buffered saline solution that the advertiser claimed mimicked the level of fluid found in a mouth during a typical brushing.  The toothbrush bristles remained two to three millimeters away from the teeth surfaces for the entire fifteen seconds of brushing time.  Three treatment arms were used: a Sonicare FlexCare power toothbrush, the Oral-B Triumph 9000 and a control (a FlexCare toothbrush powered down with no bristle movement; any biofilm bacteria removed would be the result of the fluid forces in the environment).[25]  The Aspiras Study data showed that the FlexCare removed 73.3 percent of interproximal plaque while the Oral-B removed 22.8 percent – or, in other words, the FlexCare power toothbrush was 3.2 times more effective at plaque removal than the Oral-B Triumph 9000. 

    It is well-established that claims of superior efficacy – which have a powerful impact on consumers (even if they are professionals) — such as the advertisers claim that Sonicare FlexCare is demonstrated in vitro to remove three times more plaque biofilm than Oral-B Triumph must be supported by competent and reliable test methodology.  NAD has repeatedly found that testing products according to the manufacturer’s use instructions is a critical indicium of reliability.[26]  Clearly, in the Aspiras Study, the Oral-B toothbrush was not tested according to the manufacturer’s instructions or even typical consumer usage because the toothbrush bristles never touched the typodont.  The methodology was skewed in favor of the FlexCare’s mechanism of action – its sonic capability – which is admittedly not the mechanism of action by which Oral-B Triumph toothbrushes remove plaque.  As such, the Aspiras Study does not represent a true head-to-head test that could support its broad, unqualified comparative superior performance claim. [27]

    For all the forgoing reasons, NAD recommended that the advertiser discontinue it claim that “Sonicare FlexCare is demonstrated in vitro to remove three times more plaque biofilm than Oral-B Triumph.” 

  1.             B.        “Demonstrated In Vitro To Clean Beyond The Reach Of The Bristles.”

    NAD came to a different conclusion, however, with regard to the advertiser’s monadic claim that Sonicare FlexCare power toothbrushes are “demonstrated in vitro to clean beyond the reach of the bristles.”  NAD agreed with the advertiser that the Aspiras Study demonstrated that the FlexCare toothbrushes demonstrated some cleaning effect beyond the reach of the bristles.  Also, unlike the advertiser’s claim that Sonicare “remove[s] three times more plaque biofilm,” than Oral-B, the phrase “to clean” is a vague and ill-defined term that appears in a monadic setting.  As such, it does not require the same level of substantiation as an unqualified superiority claim.  NAD was further persuaded that the claim was only directed towards dental professionals who would appreciate the nature and applicability of an in vitro claim.

    NAD was unpersuaded that the challenger’s He Study contradicted the advertiser’s evidence.  The He Study compared two treatment groups, one that brushed with a Sonicare toothbrush powered on and the other with the Sonicare deactivated, like a manual toothbrush.  NAD determined that the study was not sufficiently reliable because the toothbrush was not tested according to typical consumer usage or the manufacturer’s instructions.[28]  NAD determined that the advertiser had produced a sufficiently reasonable basis for its claim “demonstrated in vitro to clean beyond the reach of the bristles.” 

  1. Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B   Triumph.”

    The advertiser maintained that the claim “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph” was directed only towards dental professionals, yet the challenger provided Google searches that demonstrated that the claim is also directed to the general public and consequently NAD reviewed it as such.

    The parties did not submit consumer perception evidence or dental professional perception evidence and therefore NAD used its expertise to determine the reasonable messages conveyed by the advertiser’s claim that “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph.”  The advertiser’s claim could reasonably mean that FlexCare removes more plaque than Oral-B Triumph after just one brushing.  NAD further determined, however, that a reasonable consumer or dental professional could also take away the message that the efficacy of the plaque removal will remain constant throughout the recommended lifespan of the brush head.[29]  Further, NAD observed that most consumers understand that there is a causal relationship between plaque reduction and improved long-term oral health, including reduction of gum disease and tooth decay.[30]  Therefore, NAD determined that consumers could reasonably take away the message that FlexCare+ is clinically proven to be better than the Oral-B Triumph at improving oral health and preventing disease. [31]  

    “Clinically proven” health claims have a powerful impact on consumers and must be proven by reliable, competent and consumer-relevant scientific evidence.  The advertiser submitted two single use studies, the Schaeken and Putt studies, to support its claim that “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph.”  In the Schaeken Study, a cross-over study, ninety-one participants were randomly assigned to either an Oral-B or FlexCare group and baseline TMQHPI plaque scores were measured. [32]   Participants brushed for two minutes and their TMQHPI plaque scores were again assessed.  Participants returned after seven days and brushed with the power toothbrush they did not use during the previous clinical visit. [33]  TMQHPI plaque scores were again taken before and after brushing.  Overall, FlexCare achieved statistically greater plaque reduction than Oral-B, at 80.3 percent versus 72.5 percent.  The Putt Study employed the same methodology as the Schaeken Study and obtained similar results. 

    With regard to the results obtained from a single-use study, the Schaeken Study stated that:

    A single use model was used to investigate plaque removal efficacy.  The approach is recommended for assessing an ideal situation in which all subjects comply with the use of the device to which they are randomly assigned.  Therefore, the reduction in plaque score achieved with both devices represents an optimum outcome.  However, because results used from a single-use study do not automatically translate into clinically relevant benefits, such as improvement of gingival or periodontal health, these and other clinical outcomes must be determined in long-term, randomized controlled clinical trials of the products. 

    By its own admission, the advertiser’s evidence does not support a comparative long-term health claim because the results of a single-use study do not correspond to improved gum or tooth health.  While the advertiser’s two studies provide a reasonable basis to support the literal truth that after one brushing under optimal conditions that FlexCare+ power brushes remove more plaque than the Oral-B Triumph 9000, the advertiser’s claim is still misleading.  There is no evidence that supports the reasonable message that consumers will obtain better oral health outcomes over time by using a FlexCare+ toothbrush instead of an Oral-B power toothbrush, a message that is necessarily implied by the advertiser’s broad unqualified claim.  Further, there is also no evidence that the FlexCare will remain as efficacious at removing plaque during the recommended life span of the brush head; indeed the Schaeken Study states that the results represent the “optimum outcome” which is not necessarily a consumer relevant outcome.

    For all the foregoing reasons, NAD recommended that the advertiser discontinue it claim that “Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph.”[34] 

    NAD did determine however, that the Schaken and Putt studies provided a reasonable basis for a single-use superior plaque reduction claim.  NAD therefore turned to the challenger’s single-use plaque reduction study, the Biesbrock Study, to determine if its methodology, execution and results were more reliable than the advertiser’s evidence.  NAD was concerned that the Biesbrock Study had discarded its set of RMNPI plaque scores.[35]  Also, it was unclear from the study whether the easy start feature had been disabled, which could also have an effect on plaque removal as the toothbrush slowly ramps up its force on the gums and teeth over several brushings to permit the participants to become comfortable brushing with the FlexCare.  On this record, NAD was unable to determine that the Biesbrock Study was more reliable than the Schaken and Putt studies.[36]  Therefore, nothing in this decision prevents the advertiser from making a carefully qualified comparative single brushing plaque reduction claim. 

  1. The Patented Sonic Technology Of FlexCare Creates A Sweeping Motion Of The Bristles That No Other Power Toothbrush Can Match For Unparalleled Cleaning   Of The Teeth And Gums.”

    In the relevant section of the web video, the narrator states that “the patented sonic technology of FlexCare creates a sweeping motion of the bristles that no other power toothbrush can match for unparalleled cleaning of the teeth and gums” while an animated Sonicare FlexCare toothbrush head with its bristles sweeping back and forth is depicted.  The advertiser argued that the claim is puffery and an expression of a manufacturer’s pride in its product.  The challenger maintained that “cleaning” is commonly understood as the removal of plaque and debris and that “unparalleled cleaning” is a superiority claim against the entire market of power toothbrushes for which the advertiser has submitted no evidence.

    Whether a specific claim falls within puffery’s protective reach is largely dependent on whether any consumer expectations are created by the claim.  Obvious hyperbole, exaggerated displays of a manufacturer’s pride in its product and other non-provable claims, the truth and accuracy of which cannot be determined, have been found to constitute puffery.  Generally speaking, statements of puffery are claims for which reasonable consumers will not expect substantiation.  Conversely, where an objective representation is made (i.e., termed in fact rather than opinion) regarding the performance or other tangible attributes of a product that is sufficiently specific and material enough to create expectations in consumers, then substantiation for the claim is required.

    Viewing the claim in the context in which it appears (a voiceover with animated toothbrush bristles wiggling in a sweeping motion), and noting that no other performance attribute or product is featured in that particular section of the video, NAD agreed with the advertiser that the claim “unparalleled cleaning of the teeth and gums” is puffery because “cleaning” – without other qualifying descriptions — is not a sufficiently specific toothbrush performance attribute for which consumers would expect the advertiser to have support.  NAD determined that the claim “the patented sonic technology of FlexCare creates a sweeping motion of the bristles that no other power toothbrush can match for unparalleled cleaning of the teeth and gums”  is puffery for which no supporting evidence is necessary.

  1. .       Sonicare FlexCare+ Combines Patented Sonic Technology And “The Most             Advanced” Design Available In Toothbrushing.

    In the Sonicare website video, the narrator states that FlexCare combines “patented sonic technology and the ‘most advanced’ design while a close-up of the FlexCare toothbrush is shown.  In the context in which the challenged claim appears, NAD determined that the claim did not imply a superior technology claim.  The “most advanced design” is sufficiently vague and ill-defined – for example, it may mean the patented technology or it may be the aesthetics of the brush — that it is not a claim for which reasonable consumers would expect substantiation.  

  1. VI.       Gentle Brushing Action Helps Prevent Gum Recession” And “Sonicare     Toothbrushes Are Clinically Proven To Reduce . . . Gum Recession . . .  .

    “Clinically proven” claims are, in essence, a promise that there is scientific evidence that proves or “establishes” the truth of an advertiser’s claims.  Indeed, a “clinically proven” claim literally speaks to the actual testing of the product in terms of its claimed efficacy.  Therefore, in addition to requiring clinical testing that is grounded in sound methodology that yields consumer relevant results, the advertiser’s claims must also closely reflect the test results upon which they are based.[37] 

    In support of its claim that “Sonicare toothbrushes are clinically proven to reduce . . . gum recession.” the advertiser submitted the Holt Study, which did not measure gum recession but rather gingival inflammation and bleeding.[38]  The advertiser agrees with this point.  The advertiser’s argument, however, is that gingival inflammation, left unchecked, is one of several causes of gum recession and that “[a]ccordingly, treating gingivitis can prevent gum recession that results from more advanced gum disease.”  NAD noted that the advertiser submitted evidence that gingival recession is not the main cause gum recession and that the Holt Study only address one of many possible conditions that lead to gum recession.[39] 

    NAD determined that, because the Holt Study measured inflammation and bleeding reductions in people with mild to moderate gingival inflammation rather than gum recession proper and only addressed one condition of many that leads to gum recession, the advertiser’s broad, unqualified, establishment claim did not mirror the precision and specificity of the data it relied upon as substantiation.  NAD therefore recommended that the advertiser discontinue its claim that “Sonicare toothbrushes are clinically proven to reduce . . . gum recession . . .  .”  However, nothing in this decision prevents the advertiser from making truthful and accurate gingival inflammation and bleeding site reduction claims based on the Holt Study and/or more accurately explaining the relationship between gingival inflammation and gum recession. 

    NAD came to a different conclusion, however, with regard to the claim “gentle brushing action helps prevent gum recession.”  The ADA lists “aggressive and or excessive brushing” as one of the possible cause of gum recession.[40]  It is axiomatic that a “gentle brushing action” can help prevent gum recession caused by aggressive brushing.  NAD determined that the advertiser had a reasonable basis for its claim that “gentle brushing action helps prevent gum recession.”

  1. VII.     “Patients Brushed Significantly Longer Using Sonicare FlexCare+ In The Gum     Mode Than With The Oral-B Triumph With Smart Guide.”

    Both the advertiser and the challenger agree that longer brushing duration plays an important function in maintaining good oral health.  In support of its claim that “patients brushed significantly longer using Sonicare FlexCare+ in the gum mode than with the Oral-B Triumph with Smart Guide,” the advertiser submitted a study that compared an Oral-B Triumph toothbrush in a two-minute timed mode to a Sonicare FlexCare toothbrush in a three-minute timed mode.  The advertiser asserted that at the time of the study that the Oral-B did not have a three minute timed mode.  Users of the FlexCare+ Sonicare brushed for thirty-three seconds longer than Oral-B users at the first visit and twenty-five seconds longer during the second visit after the participants. 

    The claim appears as a bar graph in a brochure that is distributed to dental professionals.  Above the bar graph with challenged claim appears the text “New FlexCare+ motivated your patients to brush – leading to improved gum health.  FlexCare+ delivers an invigorating experience and exceptionally clean feel.”  NAD agreed with the challenger that the advertiser’s claim – which is silent about the two different timing modes of the toothbrushes but touts an “invigorating experience” and an “exceptionally clean feel” – implies that the FlexCare+ produced superior results because of the nature of the toothbrushes other than the different timing modes, a message which is not supported by the evidence in the record.[41]  Indeed, the advertiser’s evidence may be interpreted to prove the opposite of its claim because the study demonstrated that Oral-B users were more compliant with their brushing regimen than the FlexCare users.  Oral-B users brushed for 121 seconds out of a possible 120 seconds while FlexCare users (after the acclimation period) brushed on average 146 seconds out of 180 seconds.  Although the claim contains a footnote with the citation to the study, that footnote is extremely small and not on the page in which the claim appears; in any event, it is not an adequate disclosure of the different time modes in which the brushes were tested.  In the absence of evidence to the contrary, NAD determined that it is not sufficient to assume that busy dental practitioners will review a study cited in a brochure.

    For all the foregoing reasons, NAD recommended that the advertiser discontinue its claim that “Patients brushed significantly longer using Sonicare FlexCare+ in the gum mode than with the Oral-B Triumph with Smart Guide.”  However, nothing in this decision prevents the advertiser from pointing out that when Oral-B is in a two-minute timed mode and the FlexCare+ is in a three minute timed mode that the FlexCare users brushed longer 

  1. Sonicare FlexCare+ . . . Cause[s] 50% Less Dentin Wear . . .” And Is “Two Times Gentler On Dentin Than Oral-B Triumph.”

    Dentin is a hard calcareous tissue, similar to but denser than bone, that forms the major portion of a tooth and, in a healthy mouth, is situated beneath the enamel.  When people have exposed dentin, for example through gingival disease or after periodontal surgery, they may experience extreme sensitivity to hot, cold or pressure on their teeth.  Brushing gentleness and its effect on dentin wear is of interest to dental professionals who have patients with sensitive teeth. 

    In the advertiser’s de Jager Study, dentin samples were taken from extracted human teeth, mounted in a crown molding and exposed to various brushing loads by either a FlexCare, Oral-B Triumph or manual toothbrush.  The de Jager Study used 90, 150 and 250 grams of force on the Sonicare, Oral-B and manual toothbrushes, respectively.  The de Jager Study claimed that it selected those different force loads from a 1996 consumer-use study.  The de Jager study concluded that that FlexCare toothbrush caused “50% less dentin wear” or, alternately, was twice as gentle on dentin” as the Oral-B Triumph (37.8 µm of wear vs. 80.9 µm wear).  The study also exposed the dentin to 150 grams of force from all three brushes and reached the same conclusion (38.6 µm of wear vs. 80.9 µm of wear).

    NAD was concerned that the claim was too broad with regard to “dentin wear” because the de Jager Study was tested on exposed dentin that better mimicked the condition of a subset of patients with sensitive teeth rather than the more general population of patients with healthy mouths whose dentin is covered by enamel.[42]  However, NAD was satisfied that this claim was made to dental professionals who would understand that the study was directed towards that population of patients with exposed dentin. 

    NAD was, however, concerned about the disparate force loads applied by the FlexCare and Oral-B Triumph on the dentin.  The consumer-use study from which the de Jaeger Study selected the consumer relevant brushing loads was fifteen years old and did not test the current versions of FlexCare or Oral-B on the market today.  Therefore, NAD determined that the results from the disparate load force tests were not sufficiently reliable to support the advertiser’s claim. 

    The advertiser’s study did also test both toothbrushes (and a manual toothbrush) at 150 grams of force.  However, the advertiser did not submit any evidence as to whether 150 grams of force is a consumer relevant force for modern power toothbrushes.[43]  NAD therefore recommended that the advertiser discontinue the claim that  Sonicare FlexCare+ . . . Cause[s] 50% Less Dentin Wear . . .” and is “Two   Times Gentler On Dentin Than Oral-B Triumph.”[44]

  1. IX.       Sonicare FlexCare+ Is The “#1 Recommended Brand By Dental Professionals.”

    The parties agree that Sonicare is the “#1” recommended brand of power toothbrushes and that Oral-B is the most recommended manual toothbrush brand.  The question is whether the claim on its packaging that Sonicare FlexCare is the “#1 Recommended Brand By Dental Professionals” implies that Sonicare the most recommended brand of all types of toothbrushes, including both manual and power toothbrushes. 

    On the front of the Sonicare product box, on the lower right hand side, is a “#1” encircled by the text “recommended brand ● by dental professionals.”  The entire claim is approximately two inches in diameter.  The front of the box also has a picture of the FlexCare toothbrush and a monadic list of its attributes.  On the side of the box the claim is qualified in clear and readable type “Sonicare is the power tooth brush recommended by U.S. dental professionals” and on the back with the statement “more dental professionals worldwide recommend Sonicare than any other sonic toothbrush.” 

    NAD determined that in the context in which the “#1” claim appears – in small type on the front of the box, properly qualified on the side and the back of the packaging – surrounded by monadic attributes of a power toothbrush, that a reasonable consumer would understand the claim to refer to power toothbrushes. 

    NAD also reviewed the print and website material where the #1 claim appears.  On the advertiser’s website, the #1 circle (“#1” encircled by the text “recommended brand ● by dental professionals) appears next to the claim that Sonicare is the “#1 recommended sonic toothbrush brand,” which clearly limits the #1 claim to sonic (power) toothbrushes.  In a sales brochure distributed to dental professional the claim “#1 recommended brand by dental professionals” appears on a page outlining the FlexCare’s design features.  NAD determined that the overall net impression of the print and web site advertising limits the #1 claim to power toothbrushes because it is accompanied by monadic descriptions of the power toothbrushes.

    For all the foregoing reasons, because of the context in which the claim appears (surrounded by power toothbrush attributes), NAD determined that the advertiser had provided a reasonable basis for it claim that Sonicare is “#1 Recommended Brand By Dental Professionals.”  

    Conclusion:

    NAD recommended that the advertiser discontinue the following unsupportable claims:

    Sonicare FlexCare is demonstrated in vitro to remove three times more plaque biofilm than Oral B-Triumph.”

    Sonicare FlexCare+ is clinically proven to remove more plaque than . . . Oral-B Triumph.”  NAD determined, however, that the advertiser had provided a reasonable basis for a carefully qualified single-use superior plaque reduction claim.

    Sonicare toothbrushes are clinically proven to reduce . . . gum recession . . .  .”  However, nothing in this decision prevents the advertiser from making truthful and accurate gingival inflammation reduction claims based on the Holt Study

                “Patients brushed significantly longer using Sonicare FlexCare+ in the gum           modethan with the Oral-B Triumph with Smart Guide.”  However, nothing in this        decision prevents the advertiser from pointing out that when Oral-B is in a two-minute timed mode and the FlexCare+ is in a three minute timed mode that the FlexCare users brushed longer.

      “Sonicare FlexCare+ . . . cause[s] 50% less dentin wear . . .” and is “two times     gentleron dentin than Oral-B Triumph

    NAD determined that the advertiser had provided a reasonable basis for the following claims:

                “Demonstrated in vitro to clean beyond the reach of the bristles.”

    The patented sonic technology of FlexCare creates a sweeping motion of the bristles that no other power toothbrush can match for unparalleled cleaning of the teeth and gums.”

                “[G]entle brushing action helps prevent gum recession.”

    Sonicare FlexCare+ combines patented technology and “the most advanced”” design available in toothbrushing

                “Sonicare FlexCare+ Is The #1 Recommended Brand By Dental Professionals”

    Advertiser’s Statement:

    Philips Oral Healthcare, Inc. (“Philips”) is grateful for NAD’s thoughtful review of this challenge, and particularly for its finding that Philips’ science supports many of the challenged claims, including the “beyond the bristles” cleaning capabilities of the Sonicare line of products.  Philips is also delighted with NAD’s finding that the evidence supports Philips’ presentation of its statements that the Sonicare FlexCare and Sonicare FlexCare+ are “The #1 Recommended Brand By Dental Professionals,” employ “the most advanced” design, provide “unparalleled cleaning of the teeth and gums,” and “help to reduce gum recession.”  Philips also appreciates NAD’s guidance regarding the ways to describe the comparative plaque removal capabilities of the Sonicare FlexCare and FlexCare+, and how to describe the benefits of the FlexCare+ gum mode timer.

     Philips respects the self-regulatory process and will take appropriate steps to address NAD’s concerns in preparing future advertising.  (#5320 KAD, closed 04/15/2011)

    [1] The challenger has changed the name to Oral-B Triumph 5000 but it is substantially the same product.

    [2] In a crossover study, subjects receive a sequence of different treatments (or exposures) and subjects serve as their own control.

    [3] There are at least two industry standard methods to measuring plaque.  TMQHPI represents the broad surface area of the whole buccal or lingual surfaces while giving focus to the gingival third of the tooth and grades plaque and debris on a scale 0-5 (0=no plaque/debris, 5=plaque covering two-thirds or more of the crown of the tooth)  The RMNPI extends the scoring of plaque in approximal (mesial and distal) tooth areas and at the gumline (marginal gingival) region as well as the total tooth.

    [4] As support for its argument that single use studies are insufficient to support a comparative superiority claim the challenger cited Oral-B Laboratories (Oral-B CrossAction Toothbrush), Report # 3592, NAD/CARU Case Reports (October 1999) 

    [5] The challenger further argued that the Williams Study used the industry standard Loe-Silness Gingival Index to account for the bleeding sites and other factors in gingivitis, including inflammation, color and consistency. 

    [6] Although it may be more advanced than the previous Sonicare power toothbrush, the challenger maintained that the message is comparative as against all toothbrushes on the market.

    [7] Black, MS, Craig, A New Generation of Sonicare Power Toothbrushes – The FlexCare Series, 28 Compendium of Continuing Education in Dentistry (Supplement) 4 (November 2007).

    [8] Dental plaque is a multispecies biofilm of microorganisms that grow as an ecosystem on the hard and soft tissues in the oral cavity.

    [9] Mission Pharmacal (Citrical Calcium Supplements), Report #4045, NAD/CARU Case Reports (May 2003); Optiva Corporation (Sonicare Toothbrush), Report #3229/3230, NAD/CARU Case Reports (August 1995); Optiva Corporation (Sonicare Toothbrush), Report #3115, NAD/CARU Case Report (May 1994).

    [10] The advertiser also criticized as unreliable the three studies that the challenger claimed proved under consumer relevant conditions that the Oral-B Triumph removed more plaque than the FlexCare toothbrush.  The advertiser’s critique of the Goyal, Bierbrock and Williams study are addressed in Section II, infra

    [11] The advertiser further argued that NAD has previously considered this claim in 1995 and determined that the “beyond the bristles” claim was adequately supported by in vitro testing alone.  Optiva Corporation (Sonicare Toothbrush), Report # 3229/3230, NAD/CARU Case Reports (August 1995).

    [12] The advertiser further noted that the challenger had submitted a study stating that “single brush studies are prevalent in oral clinical research and have been frequently reported in the literature.”  Williams, Karen, A Study Comparing the Plaque Removal Efficacy of an Advanced Rotation-Oscillation Power Toothbrush to a New Sonic Toothbrush, 19 J. Clinical Dentistry 2008, at 154-58.

    [13] Both the Oral-B and Sonicare groups achieved statically significant positive results over baseline.

    [14] Williams, Karen, Comparison of Rotation/Oscillation and Sonic Power Toothbrushes on plaque and Gingivitis for 10 Weeks, 22 Am. J. of Dentistry 6, 348 (December 2009).

    [15] The advertiser also argued that the huge disparity between the beginning mean number of bleeding site between the two groups (the Sonicare had significantly more bleeding sites) and the differences in the average reduction of the bleeding sites by the end of the study further called the test methodology and results into question.

    [16] Indeed, the term “cleaning” is not an objectively definable term. 

    [17] The advertiser maintained that it invested ten million dollars in the research and development of the FlexCare+ which has resulted in five patents. 

    [18] Holt, BDS, Jon, A Randomized Parallel-Design Study to Compare the Effects of the Sonicare FlexCare and Oral-B P40 Manual Toothbrush on Plaque and Gingivitis, Compendium Continuing Educ. Dentistry (Supp.), 35-41 (Sept. 2007).

    [19] The advertiser argued that the American Dental Association lists “gums that bleed during brushing” as one of the signs of periodontal (i.e., gum) disease.  Further, the ADA lists periodontal disease as one of several causes of gingival recession.  Thus, gum bleeding is a sign of periodontal disease which is a cause of gum recession.

    [20] The advertiser claimed that at the time of the study that the Oral-B Triumph only has a two minute timed mode.

    [21] Van der Weijden, GA, Toothbrush force in relation to plaque removal, 23 Journal of Clinical Periodontology 724 – 29 (1996).

    [22] Oral-B is the most recommended brand of manual toothbrushes.

    [23] NAD took into consideration that the claims were directed to a sophisticated audience, but noted that even professionals are entitled to receive truthful, accurate and non-misleading advertising.  Elanco Animal Health Division (Comfortis® Chewable Tablets), Report #5134, NAD/CARU Case Reports (January 2010);

    The National Concrete Masonry Association (Gypsum & Concrete Masonry Wall Systems)Report  #4084, NAD/CARU Case Reports (August 2003).

    [24] Indeed, such an assumption is axiomatic.  See, e.g., Avon Products, Inc. (CELLU-SCULPT Anti-Cellulite Slimming Treatment), Report #4124, NAD/CARU Case  Reports (January 2004) (holding that the home use study, which instructed participants to apply the product for “at east 5 minutes each time” twice a day was not in accordance with the product’s use instructions which, though indicating that the product should be applied twice daily, did not specify the length of application time); Mission Pharmacal (Citracal), Report #3472, NAD/CARU Case Reports (July 1998) (holding that the advertiser’s testing, administered at inappropriately high dosages and under fasting conditions, contravened Os -Cal’s product use instructions); Amden Corporation (Smile White Tooth Whitening System), Report #4048, NAD/CARU Case Reports (July 2003) (holding that product testing submitted as substantiation for a performance claim should illustrate that the product was tested according to the product’s use instructions).  NAD also determined that another reasonably conveyed message is that under laboratory conditions that– because the word “plaque” is unqualified — the FlexCare power toothbrush removed more plaque throughout the whole mouth than the Oral-B Triumph. 

    [25] The study ran eight paired replicates for each of the three treatment arms.  Treatment order was randomized.

    [26] See fn 23, supra.

    [27] Further, the Aspiras Study did not measure whole mouth plaque but rather interproximal plaque and, therefore, the advertiser’s claim does not closely reflect the study’s results. 

    [28] NAD appreciated that the challenger was attempting to isolate the “sonic” effect from the mechanical action of the brush movement on plaque removal in human mouths, but the He Study merely reduced the Sonicare power toothbrush to a manual toothbrush.

    [29] Oral-B Laboratories (Oral-B CrossAction Toothbrush), Report # 3592, NAD/CARU Case Reports (October 1999).

    [30] Ibid. (NAD has encountered the “plaque removal” phrase in the past… and the fact that there are several reasonable interpretations of the term plaque removal, imposes upon the advertiser the duty to provide substantiation for all such interpretations or clearly communicated the parameters of its supporting information (internal quotations omitted)).

    [31] In a previous power toothbrush case, Oral-B Laboratories (Oral-B CrossAction Toothbrush), Report # 3592, NAD/CARU Case Reports (October 1999), NAD came to a different conclusion that an advertiser’s “plaque removal” claim referred to the “mechanical action” of the toothbrush and not long term “health affects” or effectiveness against conditions such as gingivitis.  However, in that case, the “plaque removal” phrase was closely associated with the CrossAction bristle features and their collective ability to “penetrate,” “lift” and “sweep away” plaque, thus leading to a different determination.

    [32] At a prior visit, participants received instructions on how to brush with their specific power toothbrush, and used the brush at home for a one week familiarization period.  Before going to the clinic to have their plaque scores measured participants refrained from oral care for twenty-four hours.

    [33] Participants again received instructions on how to brush with their next power toothbrush and had another one week familiarization period.

    [34] NAD did not have to reach whether the challenger had put forward more reliable evidence because the advertiser had not established a reasonable basis for its claim.  Looking at the challenger’s evidence, with regard to the Williams Study, NAD agreed with the advertiser that a study that does not reject the null hypothesis is not equivalent to demonstrating parity between two items; it simply means that the study was not sufficiently powered to detect a difference.  However, the Williams Study did find a statistically significant performance improvement gingivitis scores at four and ten weeks and given that NAD determined that the challenged claim conveyed a long-term health message, NAD would have taken that aspect of the Williams Study into consideration.  Similarly, the Goyal Study appropriately looked at long-term plaque reduction scores between the two toothbrushes. 

    [35] NAD understood that the TMQHPI scores were also taken and balanced.  NAD’s concern about the reliability of the study was that it had begun to obtain a second set of scores and then abandoned the process. 

    [36] As for the criticisms regarding the steps taken to familiarize the participants to either the FlexCare or the Oral-B power toothbrushes and the washout periods, the parties had different expert opinions on how these tasks were to be accomplished, both parties critiqued each other’s methodology.  However, beyond conflicting expert statements, neither party submitted any evidence from independent third party sources (for example, industry guidelines and recommendations, reference manuals or other studies that employed their preferred methodology), that would permit NAD to evaluate the dueling studies in this regard.  Finally, NAD did not find persuasive the advertiser’s argument that because the Biesbrock Study did not screen for power toothbrush consumers that the study was biased towards Oral-B users because Oral-B has a greater market share in the toothbrush category.  No evidence was submitted to support this argument. 

    [37] See Johnson & Johnson Consumer Companies, Inc.(Aveeno Advanced Relief Cold Sore Treatment), Report # 4719, NAD/CARU Case Reports (September 2007).

    [38] Again, the Holt Study was a four week single blind, randomized clinical trial where the subjects were assigned to two groups: one group brushed twice daily with Sonicare FlexCare+ toothbrushes and the second group brushed twice daily with a manual toothbrush.  The gingival inflammation scores of the FlexCare+ group were reduced by a statistically significant 28.4% and their bleeding scores were lowered by 43.9% over the four-week study

    [39] The main cause of gum recession is irregular or abnormal tooth position.  Other factors that can lead to gum recession include heredity, trauma to gingival tissue and aggressive/excessive brushing.  Gingival Recession: Causes and Treatments, 138 JADA 1404, 1404 (October 2007).

    [40] Gingival Recession: Causes and Treatments, 138 JADA 1404, 1404 (October 2007).

    [41] NAD further determined that describing the mode of the toothbrushes, i.e., the FlexCare+ was in the “Gum Mode” and the Oral-B had the “Smart Guide” was not an adequate disclosure of the time periods the brushes were tested for because it assumes that dental professionals have a level of familiarity with the toothbrushes that has not been demonstrated in this record.  Further, this claim may be even more misleading now that the Oral-B has a three minute timed mode, thus implying that when both brushes are tested at three minutes that FlexCare+ users are more compliant brushers, a message that is not supported by the evidence in the record. 

    [42] NAD noted that in vitro models were the only ethical manner in which to study the effects of brushing on exposed dentin.

    [43] NAD was further concerned that consumers with exposed dentin might also brush with less force than the general population because of their sensitivity.

    [44] It is the advertiser’s burden to provide a reasonable basis for its claims.