Efficacy of a Whitening Dentifrice on Tooth Discoloration
- Conditions
- Tooth Discoloration
- Interventions
- Other: Whitening toothpasteOther: Conventional toothpasteOther: 10% carbamide peroxide
- Registration Number
- NCT02741427
- Lead Sponsor
- Federal University of Paraíba
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- To have six maxillary anterior teeth with a mean shade of C1 or darker (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany),
- With active caries or periodontal disease,
- Presenting non-vital anterior teeth,
- Previous hypersensitivity,
- Under orthodontic treatment,
- With structural defect in the enamel,
- Who had used tooth whiteners within the previous 3 years,
- Smokers,
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G2 (group 2) - Whitening toothpaste Whitening toothpaste G2 used a whitening toothpaste containing blue pigment in daily oral regimen G1 (group 1) - Conventional toothpaste Conventional toothpaste G1 used a conventional toothpaste in daily oral regimen G3 (group 3) - 10 % Carbamide peroxide 10% carbamide peroxide G3 made an at-home tooth bleaching with 10 % Carbamide peroxide
- Primary Outcome Measures
Name Time Method Tooth shade changes from baseline until 4 weeks of the beginning of intervention Baseline, Immediately after first product application, 2 weeks and 4 weeks of the beginning of interventions The tooth shade evaluation was performed at each time frame using the digital spectrophotometer that provided tooth shade via two different methods: using the 16 shade tabs in the Vita shade guide (B1-C4); and the CIEL\*a\*b\* color system. The difference between the color coordinates was calculated as: ∆E\*= \[(∆L\*)2 + (∆a\*)2 + (∆b\*)2\]1/2, where ΔL\*, Δa\*, and Δb\* are the mathematical differences among CIE L\*, a\*, and b\* at the different time frames and baseline measurements.
- Secondary Outcome Measures
Name Time Method Tooth sensitivity and gingival irritation evaluation Daily during three weeks Each subject should record tooth sensitivity or gingival irritation on a daily basis for 3 weeks (2 weeks of treatment and 1 week after treatment). They should use a standardized grading scale ranked as follows: 0, no sensitivity; 1, mild sensitivity; 2, moderate sensitivity; 3, considerable sensitivity; and 4, severe sensitivity
Subjects' perception about improvement on tooth color 2 weeks of the beginning of interventions After two weeks of treatment, the subjects received a visual analog scale (VAS) ranging from 1 (no improvement in tooth appearance) to 7 (exceptional improvement in tooth appearance), in order to evaluate their satisfaction level with tooth appearance
Acceptability of interventions 2 weeks of the beginning of interventions The acceptability of the three products was assessed using a questionnaire containing six questions about the opinion of subjects regarding the treatment regimen adopted. The questions were scored from positive to negative answers, as follows: 1, agree; 2, neither agree nor disagree; and 3, disagree. The questions related to sufficient instruction, ease of use, comfort level, perceived taste, and overall satisfaction.