- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Jossaria P Sousa, Master, Federal University of Paraíba
Publications and helpful links
General Publications
- Meireles SS, Santos IS, Bona AD, Demarco FF. A double-blind randomized clinical trial of two carbamide peroxide tooth bleaching agents: 2-year follow-up. J Dent. 2010 Dec;38(12):956-63. doi: 10.1016/j.jdent.2010.08.003. Epub 2010 Aug 13.
- Walsh TF, Rawlinson A, Wildgoose D, Marlow I, Haywood J, Ward JM. Clinical evaluation of the stain removing ability of a whitening dentifrice and stain controlling system. J Dent. 2005 May;33(5):413-8. doi: 10.1016/j.jdent.2004.10.021. Epub 2004 Dec 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUofParabia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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