A TV ad for Oral B 3D White Luxe Perfection toothpaste seen on 21 January featured a voice-over that stated, “[N]ew Oral B 3D White Luxe Perfection. It removes up to 100% of surface stains in 3 days”. During this time, there were visual effects showing before and after images of teeth with text that stated “… UP TO 100% IN 3 DAYS* ORAL B 3D WHITE LUXE *After 3 days of usage **by removing surface stains”.
Colgate-Palmolive UK Ltd, who considered that the ad exaggerated the product's efficacy, challenged whether the claim “It removes up to 100% of surface stains in 3 days” was misleading and could be substantiated.
Procter & Gamble (Health & Beauty Care) Ltd (P&G) provided a copy of the clinical study that was conducted by an American university to assess the effect of the Oral B 3D White Luxe Perfection toothpaste and a professional tooth cleaning treatment (‘prophylaxis’) in removing extrinsic tooth stain that was followed by normal oral care hygiene over a two-week period. P&G stressed that the objective was not to compare the two treatments and that the claim was solely based on the results obtained for the treatment group that tested the Oral B 3D White Luxe Perfection toothpaste.
P&G stated that the study had been published and peer reviewed which involved 50 healthy adults with 25 subjects assigned to each of the two treatments where the prophylaxis group continued their usual oral hygiene routine. Subjects were gathered based on baseline Lobene composite score, age and gender and were then randomly assigned to one of the treatment groups according to balance and assignment schedule. Regarding the inclusion criteria of the study, P&G stated that each subject had to: be at least 18 years of age; sign an informed consent form and be given a copy; agree to delay any non-study dentistry, including dental prophylaxis and to report any dentistry received during the course of the study; have at least six scorable anterior teeth free of crowns, large restorations and calculus; and have visible stain on the facial surface of at least two anterior teeth with a mean Lobene score of >1.5. Regarding the exclusion criteria, subjects were excluded from study participation due to: severe periodontal disease; any disease or conditions that could interfere with the subject safely completing the study; fixed orthodontic appliances; and generalised malocclusion or overlapping of the teeth.
P&G explained that after baseline data was recorded and treatments administered on the first day of the study, assessments of staining were performed by an experienced examiner using the interproximal modified lobene stain index (IML) after three days and at two weeks. P&G stated that the table named “Stain reduction of subjects using Oral-B 3D White Perfection” showed that after three days the Oral B 3D White Luxe Perfection toothpaste achieved a median stain reduction of 100% and remained so after two weeks. There were no statistically significant differences between subjects using the Oral B 3D White Luxe Perfection toothpaste and those in the prophylaxis group at either the three-day or two-week measurements, which P&G believed further showed that the results were achieved after three days of use.
P&G stated that the Oral B 3D White Luxe Perfection toothpaste contained ingredients which contributed to the stain removal performance of the product.
Clearcast stated that at the pre-production script stage, they received a clinical study from P&G to support the claim “It removes up to 100% of surface stains in 3 days”, which they sent to a dental consultant for review. Clearcast were advised that the study showed that the Oral B 3D White Luxe Perfection toothpaste was as effective as a professional prophylaxis in removing stains after three days continued usage, which they believed was made sufficiently clear in the ad.
The expert was informed that only the control group received a professional cleaning consisting of scale and polish (prophylaxis) after enrolling in the study and considered its design was satisfactory in terms of blindness, numbers and randomisation. Furthermore, the expert believed that it applied a well-recognised and widely used method of evaluating tooth staining and that the prophylaxis would be regarded as the gold standard for stain removal from teeth. The expert considered that the findings showed that the Oral B 3D White Luxe Perfection toothpaste was effective as a professional prophylaxis in removing stains after three days usage.
The ASA considered that viewers would interpret the claim “It removes up to 100% of surface stains in 3 days” to mean that the Oral B 3D White Luxe Perfection toothpaste could remove surface stains by up to 100% within three days.
We took expert advice with regards to the adequacy of the study P&G had provided. We acknowledged that the study’s objective was to assess the effectiveness of the Oral B 3D White Luxe Perfection toothpaste and a professional tooth cleaning (described as prophylaxis) for removing surface stains from teeth, the latter of which we understood was the gold standard for stain removal from teeth.
We noted that the sample population of the study was 50 healthy adults divided into two groups. The treatment group used the Oral B 3D White Luxe Perfection toothpaste while the comparator group received professional tooth cleaning.
We understood that the claim “It removes up to 100% of surface stains in 3 days” was based on an in-house clinical study for P&G’s Oral B 3D White Luxe Perfection toothpaste. Whilst P&G had provided us with the full report, we understood that it was presented as an abstract at the 2016 meeting of the American Association for Dental research and was subsequently published as such in a scientific journal. Although we recognised the abstract form of the study would have been subject to an element of peer review, it might not have been commensurate with the peer review process had it been submitted in full. However, in terms of how adequate the study was, we considered that the design was satisfactory in that it was a randomised, positive control, parallel group, examiner blind investigation of two weeks’ duration. The numbers in each treatment group were adequate and of sufficient power to detect significant differences in outcomes. The two treatment groups were appropriately stratified for age and teeth stain levels. The test group were asked to brush their teeth with the Oral B 3D White Luxe Perfection toothpaste twice daily for 2 minutes and the control group underwent a full professional tooth cleaning procedure. They then continued with their normal oral hygiene throughout the two-week investigation period.
We also considered that a well recognised method was used to assess the level of stain on the surfaces of the test teeth. Furthermore, the statistical analysis for outcome measures was sufficient. The results showed that the test group that was given the Oral B 3D White Luxe Perfection toothpaste exhibited a significant difference in stain reduction when compared to baseline. Furthermore, in terms of percentage stain reduction, the test group exhibited 100% reduction of stain at 3 and 14 days after use.
We therefore considered that P&G had provided adequate evidence showing that the Oral B 3D White Luxe Perfection toothpaste could remove surface stains by up to 100% within three days and concluded that the claim “It removes up to 100% of surface stains in 3 days” had been substantiated and was not misleading.
We investigated the claim under BCAP Code rules 3.1 3.1 Advertisements must not materially mislead or be likely to do so. (Misleading advertising), 3.9 3.9 Broadcasters must hold documentary evidence to prove claims that the audience is likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation. (Substantiation) and 3.12 3.12 Advertisements must not mislead by exaggerating the capability or performance of a product or service. (Exaggeration), but did not find it in breach.
No further action necessary.