Efficacy of a Whitening Dentifrice on Tooth Discoloration

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tooth Discoloration

Intervention / Treatment
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* Other: Conventional toothpaste
* Other: Whitening toothpaste
* Other: 10% carbamide peroxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have six maxillary anterior teeth with a mean shade of C1 or darker (Vitapan Classical, Vita Zahnfabrik, Bad Sackingen, Germany), Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: G1 (group 1) - Conventional toothpaste<br>G1 used a conventional toothpaste in daily oral regimen | Other: Conventional toothpaste<br>* 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.<br>* Other names: Colgate Máxima Proteção Anticáries;|
| Experimental: G2 (group 2) - Whitening toothpaste<br>G2 used a whitening toothpaste containing blue pigment in daily oral regimen | Other: Whitening toothpaste<br>* 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.<br>* Other names: Close up White Now;|
| Active Comparator: G3 (group 3) - 10 % Carbamide peroxide<br>G3 made an at-home tooth bleaching with 10 % Carbamide peroxide | Other: 10% carbamide peroxide<br>* 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<br>* Other names: Whiteness perfect 10%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth shade changes from baseline until 4 weeks of the beginning of intervention | 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. | Baseline, Immediately after first product application, 2 weeks and 4 weeks of the beginning of interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects' perception about improvement on tooth color | 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 | 2 weeks of the beginning of interventions | 
| Tooth sensitivity and gingival irritation evaluation | 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 | Daily during three weeks | 
| Acceptability 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. | 2 weeks of the beginning of interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth discoloration, Toothpaste, Tooth bleaching, Clinical trial