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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02935114
Other study ID # UFSSergipe
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2016
Last updated November 12, 2016
Start date May 2016
Est. completion date November 2016

Study information

Verified date November 2016
Source Universidade Federal de Sergipe
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior superior teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the tooth sensitivity before, during and 24 hours after the procedure.

Materials and Methods: Fifty patients will be selected for this single-blind, parallel, randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or 35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes for two sessions with a 7-day interval. The sensitivity level will be assessed before, during and 24 hours after the procedure using verbal and analogic visual analogue (VAS) scales. Color alteration will be assessed by a bleach guide scale 7 days after each session and 30 days after the last session. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by McNemar's test. Data on the sensitivity level for both scales will be subjected to the Mann-Whitney tests (α = 0.05). The color change will be measured with a spectrophotometer using the CIE L * a * b * and the L*, a * and b * parameter delta data, and ΔE and Δ00, will be individually subjected to two-way repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time (α = 0.05).


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
37% Carbamide Peroxide
no Gingival dam protection (as manufacturer´s instruction) 37% Carbamide Peroxide application (2 sessions of 45 minutes) Tooth sensitivity (Verbal and visual scale) and color evaluation
35% hydrogen Peroxide
Gingival dam protection (as manufacturer´s instruction) 35% Hydrogen Peroxide application (2 sessions of 45 minutes) Tooth sensitivity (Verbal and visual scale) and color evaluation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Sergipe

Outcome

Type Measure Description Time frame Safety issue
Primary Color evaluation Clinical efficacy of bleaching agent 37% carbamide peroxide compared to 35% hydrogen peroxide (active control). The color change will be measured with a spectrophotometer using the CIE L * a * b * and the L*, a * and b * parameter delta data, and ?E and ?00. Prior to bleaching procedure, after 7, 14 and 37 days. Yes
Secondary Risk to the tooth sensitivity The tooth sensitivity will be evaluated using a 5-point Verbal rating scale (VRS), where 0 = none, 1 = mild, 2 = moderate, 3 = considerable and 4 = severe. Score different from 0 will determine presence of sensitivity. The risk of tooth sensitivity will be determined by relative risk assessed by ratio between absolute risk of experimental condition by those observed in control. The 95% confidence interval will be calculated. During the bleaching procedure, immediately after bleaching agent removal and up to 24 hours after each session. Yes
Secondary Level of tooth sensitivity The tooth sensitivity also will be evaluated using a analogic visual analogue (VAS) consisted of a scale 10 cm in length ranging from 0 (absence of pain) to 10 (unsupportable pain). The patient set his or her level of sensitivity by pointing on the scale corresponding to this level, while the distance from this point to the 0 border will be recorded. During the bleaching procedure, immediately after bleaching agent removal and up to 24 hours after each session. Yes
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