IN-OFFICE TOOTH BLEACHING WITH 37% CARBAMIDE PEROXIDE

NCT02935114 | Completed Phase 3

• 1 other identifier: UFSSergipe
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Tooth Sensitivity

Keywords

Tooth Bleaching; Tooth Bleaching Agents; Tooth Whitening; Hydrogen Peroxide; Carbamide Peroxide

Outcome Measures

Primary Outcomes (1)

• 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 ΔE and Δ00.

  Prior to bleaching procedure, after 7, 14 and 37 days.

Secondary Outcomes (2)

• Risk to the tooth sensitivity

  During the bleaching procedure, immediately after bleaching agent removal and up to 24 hours after each session.

• Level of tooth sensitivity

  During the bleaching procedure, immediately after bleaching agent removal and up to 24 hours after each session.

Study Arms (2)

37% Carbamide Peroxide

EXPERIMENTAL

* 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

Drug: 37% Carbamide Peroxide

35% Hydrogen Peroxide

ACTIVE COMPARATOR

* 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

Drug: 35% hydrogen Peroxide

Interventions

37% Carbamide Peroxide DRUG

* 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

37% Carbamide Peroxide

35% hydrogen Peroxide DRUG

* 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

35% Hydrogen Peroxide

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients included in this clinical trial will be at least 18 years old with good oral health. Only patients presenting canine upper teeth with shade mismatching with 2.5 M2 (Vita Bleach guide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.

You may not qualify if:

• Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, pregnant or breastfeeding will be also excluded.

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Carbamide Peroxide; Hydrogen Peroxide

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Urea; Amides; Organic Chemicals

Study Officials

• Aline C Peixoto

  Universidade Federal de Sergipe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share