NCT02741427

Efficacy of a Whitening Dentifrice on Tooth Discoloration

Safety, Acceptability and Efficacy of a Silica Dentifrice Containing Blue Pigment on Tooth Whitening: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products.

Detailed description

The study was approved by local Ethical Committee under protocol number CAAE: 035541412.7.0000.5188, and each volunteer signed an informed consent form prior to enrollment in the study. The sample size calculation was carried out based on a previous study. To detect the bleaching effect with a power of 80% and a one-tailed alpha error of 5%, a sample size of 20 subjects in each treatment group was necessary to detect a 20% difference between groups in shade change. A 20% addiction in subjects' number, taking into consideration potential loss or refusal, gave a total sample size of 75 subjects (25 in each group). The individuals were invited to participate in this clinical trial through advertisement exposed at the Federal University of Paraíba, Brazil. Basing on eligibility criteria, 75 volunteers were selected to the trial and randomized to one of the three groups of treatment: G1- brushing teeth with a conventional toothpaste; G2- brushing teeth with a silica whitening dentifrice containing blue pigment; and G3 - at-home tooth bleaching with 10% carbamide peroxide. The treatments will be detailed in another section. It was used a simple randomization to allocate the subjects, and a randomization table was prepared in the Excel Program by a member, not directly involved with the clinical part of the study. To mask the products used in the treatment groups, each toothpaste type was enveloped with an adhesive tape of a different color and the seal of the bleaching gel syringe was removed. The same examiner responsible for subject allocation did this procedure. Thus, testing with the toothpastes was double-blinded, where both evaluator and subject did not know which toothpaste was being used. The outcomes evaluated were: tooth shade, subjects' perception about tooth color appearance, and safety and acceptability of products tested, which were measured at baseline, 2-weeks, 3-weeks and 4-weeks of the beginning of treatments. For statistical analysis, data were checked for normal distribution using the Kolmogorov Smirnov test, and then it was applied the appropriated parametric or non-parametric tests. Differences were considered statistically significant when p \< 0.05.

Conditions

• Tooth Discoloration

Interventions

Type	Name	Description
OTHER	Conventional toothpaste	The participants should brush their teeth with conventional toothpaste for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on their toothbrushes, use dental floss, but not mouth rinse.
OTHER	Whitening toothpaste	The subjects should brush teeth with whitening toothpaste containing blue pigment for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on toothbrushes, use dental floss, but not mouth rinse.
OTHER	10% carbamide peroxide	The subjects should dispense the bleaching gel at night into the trays (maxillary and mandibular) and to insert them to cover at least the anterior teeth for a period of 4 h per day, over a 2-week period. Both arches should be bleached at the same time. During the period of bleaching, volunteers should receive the same toothpaste used by G1, in other words, without "whitening agents", to standardize their oral hygiene regimen

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2016-04-18
• Last updated: 2016-04-18