Tooth Discoloration Clinical Trial
— Brief6%Official title:
Efectiveness of a Brief Protocol by a Low (6%) Concentration Gel Peroxide Hydrogen of Teeth Bleaching
Verified date | November 2015 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | Chile: Comité de Ética Científico |
Study type | Interventional |
The purpose of this clinical study was to evaluate, the effectiveness and sensitivity post-treatment of a 6% hydrogen peroxide with nitrogen-doped titanium dioxide light activated bleaching agent, the impact of shorter interval times on tooth sensitivity and to compare the efficacy with 2 different application protocols. This is a clinical randomized double-blind split-mouth study. 31 patients were treated with: one upper hemi arcade with one application of 36 minutes and the other hemi arcade with 3 applications of 12 minutes each with a 6% hydrogen peroxide. Two sessions were appointed with 48h of intervals between them. Tooth colour was registered by VITA Classical amd VITA Bleach guide by two blinded assessors in the beginning, immediately after each session. Tooth colour variation and sensitivity were compared between both application protocols
Status | Completed |
Enrollment | 31 |
Est. completion date | October 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Healthy patients with Anterior teeth without restorations, previous bleaching procedures, cervical lesions, or dental pain Exclusion Criteria: - Pregnant or lactating, - Had moderate or severe fluorosis, - Tetracycline stains, - Orthodontic treatment, - Periodontal disease, - Orofacial tumors, - Trauma, - Tooth malformation, - Were taking analgesic, anti-inflammatory, or antibiotic drugs |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Chile | Eduardo Fernandez | Santiago | N/A = Not Applicable |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Chile,
Martín J, Vildósola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernández E. Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching—A double-blind, randomized clinical trial. J Dent. 2015 Aug;43(8):965-72. doi: 10.1016/j.jdent.2015.05.011. Epub 2015 Jun 6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efectiveness by color difference ( using the spectrophotometer Vita Easy Shade) | The shade was determined using the obtained parameters L*, a*, and b* by Spectrophotometer . The color alteration after each session was given by the differences between the values obtained at the session and the baseline (?E). ?E was calculated using the following formula: ?E = [(?L*)2 + (?a*)2 + (?b*)2]1/2 . | 1 month | Yes |
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