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

NCT ID: NCT01959789

Last Updated: 2013-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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%).

Conditions

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Dentin Sensitivity

Keywords

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Randomized Controlled Clinical Trial Tooth Bleaching

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Standard treatment

No interventions assigned to this group

2 days

bleaching treatments made in 2 days

No interventions assigned to this group

Eligibility Criteria

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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).

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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).

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Estadual de Ponta Grossa

OTHER

Sponsor Role lead

Responsible Party

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Eloisa Andrade de Paula

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eloisa A Paula, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual de Ponta Grossa

Locations

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Universidade Paranaense - UNIPAR

Umuarama, Paraná, Brazil

Site Status

Countries

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Brazil

References

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de Paula EA, Nava JA, Rosso C, Benazzi CM, Fernandes KT, Kossatz S, Loguercio AD, Reis A. In-office bleaching with a two- and seven-day intervals between clinical sessions: A randomized clinical trial on tooth sensitivity. J Dent. 2015 Apr;43(4):424-9. doi: 10.1016/j.jdent.2014.09.009. Epub 2014 Sep 23.

Reference Type DERIVED
PMID: 25257824 (View on PubMed)

Other Identifiers

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name

Identifier Type: REGISTRY

Identifier Source: secondary_id

Name of trial

Identifier Type: REGISTRY

Identifier Source: secondary_id

22564/2011

Identifier Type: -

Identifier Source: org_study_id