Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

NCT ID: NCT03514797

Last Updated: 2019-04-19

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

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2018-06-30

Brief Summary

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This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.

Detailed Description

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Conditions

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Tooth Discoloration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Combined technique

A single session of in-office tooth bleaching will be performed with 35% hydrogen peroxide for 45 minutes. Following, the teeth will be further bleached with customized trays filled with 10% carbamide peroxide and used for 1h per day.

Group Type EXPERIMENTAL

Bleaching Agents

Intervention Type DRUG

In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.

Bleaching Agents

Intervention Type DRUG

At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.

At-home bleaching

The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day.

Group Type ACTIVE_COMPARATOR

Bleaching Agents

Intervention Type DRUG

At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.

Interventions

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Bleaching Agents

In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.

Intervention Type DRUG

Bleaching Agents

At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good general and oral health;
* Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

Exclusion Criteria

* Presence of non-treated caries or periodontal disease;
* Prior tooth hypersensitivity;
* Presence of gingival recession;
* Teeth with cracked enamel or any hypoplasia;
* Patients using oral removable or fixed orthodontic appliances;
* Patients were pregnant or breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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André Luis Faria e Silva

OTHER

Sponsor Role lead

Responsible Party

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André Luis Faria e Silva

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universidade Federal de Sergipe

Aracaju, Sergipe, Brazil

Site Status

Countries

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Brazil

References

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Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined Bleaching Technique Using Low and High Hydrogen Peroxide In-Office Bleaching Gel. Oper Dent. 2016 Jul-Aug;41(4):388-96. doi: 10.2341/15-266-C. Epub 2016 Feb 26.

Reference Type BACKGROUND
PMID: 26919081 (View on PubMed)

Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.

Reference Type BACKGROUND
PMID: 20884923 (View on PubMed)

Other Identifiers

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Combined bleaching

Identifier Type: -

Identifier Source: org_study_id

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