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

Dentin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959789
• Other study ID #: 22564/2011
• Secondary ID: nameName of tria
• Status: Completed
• Phase: N/A
• First received: October 6, 2013
• Last updated: October 9, 2013
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Universidade Estadual de Ponta Grossa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Brazil	Universidade Paranaense - UNIPAR	Umuarama	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Ponta Grossa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth sensibility		1 year
Secondary	Color		1 year