In-office Bleaching With a 2-day Interval Between Sessions: Tooth Sensitivity

Completed

• Conditions: Dentin Sensitivity

• Registration Number: NCT01959789
• Lead Sponsor: Universidade Estadual de Ponta Grossa

Brief Summary

The calcium containing 35% hydrogen peroxide gel employed in this study can be re-applied 2 days after the first bleaching session without increasing the bleaching-induced tooth sensitivity

Detailed Description

The in-office bleaching uses 35% hydrogen peroxide gel which is applied in 2 to 3 sessions usually with one week interval between sessions, without a scientific and plausible reason for this recommendation (. The aim of this study was to evaluate the tooth sensitivity (TS) risk using a shorter interval between clinical sessions. Methods: In this randomized, single-blind study, 40 young patients with color C2 or darker were selected and randomly divided in two groups. In the 7-day group, two bleaching sessions with a 35% hydrogen peroxide gel (Whiteness HP Blue Calcium - FGM) were performed with a one-week interval and in the 2-day group, the same protocol was performed but with a 2-day interval. TS was recorded on a 0-10 visual analog scale up to 48 h after bleaching. The color evaluation was performed at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The absolute risk of TS (%) was evaluated by Fisher´s exact. The TS intensity was evaluated by two-way repeated measured ANOVA and color changes (ΔSGU and ΔE) were evaluated by Student´s t-test (alpha = 5%).

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-12
• Study Completion: 2012-08
• Status Verified: 2013-10
• Study First Submitted: 2013-10-06
• Study First Submitted QC: 2013-10-09
• Last Update Submitted: 2013-10-09
• Study First Posted: 2013-10-10
• Last Update Posted: 2013-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

The participants should have:

At least six maxillary and mandibular anterior teeth caries-free. Without restorations on the labial surfaces. The central incisors should be C2 or darker according to a value-oriented shade guide (Vita Lumin).

Exclusion Criteria

Pre-existing anterior restorations. Pregnant/lactating. Severe internal tooth discoloration (tetracycline stains, fluorosis, pulpless teeth).

Taking any drug with anti-inflammatory and antioxidant action. Bruxism habits or any other pathology that could cause Tooth Sensbility (such as recession, dentine exposure).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tooth sensibility	1 year

Secondary Outcome Measures

Name	Time	Method
Color	1 year

Trial Locations

Locations (1)

Universidade Paranaense - UNIPAR; 🇧🇷 Umuarama, Paraná, Brazil