Efficacy of a Whitening Dentifrice on Tooth Discoloration

April 13, 2016 updated by: Jossaria Pereira de Sousa, Federal University of Paraíba

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth shade changes from baseline until 4 weeks of the beginning of intervention
Time Frame: 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.
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
Time Frame: 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
2 weeks of the beginning of interventions
Tooth sensitivity and gingival irritation evaluation
Time Frame: 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
Daily during three weeks
Acceptability of interventions
Time Frame: 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.
2 weeks of the beginning of interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jossaria P Sousa, Master, Federal University of Paraíba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tooth Discoloration

Clinical Trials on Conventional toothpaste

3
Subscribe