Safety and efficacy of Philips take-home teeth whitening gel in custom whitening trays

Objectives

The primary objective was to assess changes in tooth shade after use of Philips tooth whitening products containing hydrogen peroxide (HP) or carbamide peroxide (CP). Safety and user experience associated with the whitening products were also assessed during the study.

Methodology

This was a randomized, single-blind, parallel-design clinical trial with subjects undergoing 14 days of tooth whitening. Subjects were generally healthy adults aged 18–75 years who exhibited an average tooth shade of 2M2 (13) or darker on the facial surface of a minimum of 4 out of 6 maxillary anterior teeth, per a VITA Bleached guide 3D Master shade guide (VBG). At the screening visit, eligible subjects were randomized to one of six treatment groups per Table 1 (below) and provided with a standard manual toothbrush, string floss and dentifrice for use during the study. All groups used custom whitening trays created after enrollment. At the baseline visit, VBG scores were recorded and subjects received their whitening product. Subjects returned to the clinic for VBG assessments after 3-day, 9-day, and 14-day use periods. A final study visit to confirm efficacy and safety was conducted one week following the last application. For analysis, tooth shade was converted to a numeric value (1 to 29) for each tooth assessed. Overall shade was calculated as the average of the designated 4–6 anterior teeth, with a positive shade change indicating a whitening effect. To assess safety, each subject self-reported tooth sensitivity, whereas the investigator recorded gingival irritation using incidences of gingival erythema, edema and sloughing.

Safety

Adverse events (AEs) were reported by 24 participants, with 22 participants experiencing AEs related to the study products. All AEs were mild to moderate in severity. Subject-reported moderate tooth sensitivity included 2 subjects after 3 days use, 6 subjects after 9 days use, and 1 subject after 14 days use. Gingival irritation included 6 reports after 3 days use, 3 reports after 9 days use, and 2 reports after 14 days use. Examiner-reported erythema included 6 reports after 3 days use, 2 reports after 9 days use, and 2 reports after 14 days use. There were no reports of edema or sloughing at any visit.

User Experience

Subjects’ user experience results are presented in Table 3 (below). The results show a clear positive rating for ease of use, ease of following instructions, satisfaction with results, and perceived lasting results. Additionally, over 90% of the subjects were willing to recommend the whitening products.

Results

Of 309 subjects enrolled, 293 were dispensed treatment at baseline and 279 subjects completed the study. Sixteen discontinued before treatment, and 14 discontinued after treatment. The data analysis included all randomized subjects with a baseline and at least one post-baseline efficacy observation. See Table 2 (below).

The VBG score (least squares mean and standard error) for each group is presented in Table 2 (page 2) at baseline and after 3-, 9- and 14-days use of the whitening gel, as well as for the 1-week post-use evaluation. The change in VBG score after 3-, 9- and 14-days use is graphically presented in Figure 1, with a greater change representing more whitening.

Conclusions

In-home use of Philips Whitening products significantly whitened teeth as measured by the VITA Bleachedguide 3D Master shade guide. The efficacy was significantly improved for all whitening products after 3-, 9- and 14-days use. The take-home whitening products were safe to use and associated with little to no sensitivity. Across all products and dosing regimens, participants consistently rated the Philips Zoom! take-home whitening products positively for ease of use, easy-to-follow instructions, satisfaction with results, and perceived lasting effects.

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