Efficacy of a Whitening Dentifrice on Tooth Discoloration

Federal University of Paraíba

Status and phase: Completed; Phase 4

Conditions: Tooth Discoloration

Treatments: Other: 10% carbamide peroxide; Other: Whitening toothpaste; Other: Conventional toothpaste

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02741427

FUofParabia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

G1 (group 1) - Conventional toothpaste

Placebo Comparator group

Description:

G1 used a conventional toothpaste in daily oral regimen

Treatment:

Other: Conventional toothpaste

G2 (group 2) - Whitening toothpaste

Experimental group

Description:

G2 used a whitening toothpaste containing blue pigment in daily oral regimen

Treatment:

Other: Whitening toothpaste

G3 (group 3) - 10 % Carbamide peroxide

Active Comparator group

Description:

G3 made an at-home tooth bleaching with 10 % Carbamide peroxide

Treatment:

Other: 10% carbamide peroxide