In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.

NCT ID: NCT02816593

Last Updated: 2018-02-12

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

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-02-28

Brief Summary

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To evaluate the efficacy, safety and impact on quality of life related to oral health of home and office tooth whitening techniques in young individuals.

Detailed Description

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The aim of this study is to evaluate the efficacy, safety and impact on quality of life related to oral health of tooth whitening techniques in young individuals. It will be a randomized, parallel and single blind. Participants are divided into three groups (n = 30) according to bleaching technique to be performed (G1 = Office / hydrogen peroxide 6%; G2 = Office / hydrogen peroxide 15%; G3 = Home / carbamide peroxide 10%). The color of the teeth will be evaluated in seven different times, using the color scale Vita Master Classic 3D and spectrophotometer Vita Easy Shade Advance. IGM (1986) - the presence of tooth sensitivity by visual analogue scale and gingival security through modified gingival index will be evaluated. The impact of bleaching quality of life will be assessed using the Brazilian version of the oral impact on daily performance (OIDP). The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4). Statistical analysis include descriptive analysis and testing to compare the two bleaching techniques as the color change, sensitivity, gum irritation and impact on quality of life.

Conditions

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Discolored Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group 1 - HP 6%

Group 1: Experimental: Office; hydrogen peroxide 6%,

Group Type EXPERIMENTAL

hydrogen peroxide 6%

Intervention Type DRUG

Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application

Group 2 - HP 15%

Group 2: Experimental: Office; hydrogen peroxide 15%,

Group Type EXPERIMENTAL

hydrogen peroxide 15%

Intervention Type DRUG

Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application

Group 3 - CP 10%

Group 3: Control: Homemade; Carbamide Peroxide 10%,

Group Type ACTIVE_COMPARATOR

Carbamide Peroxide 10%

Intervention Type DRUG

Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days

Interventions

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hydrogen peroxide 6%

Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application

Intervention Type DRUG

hydrogen peroxide 15%

Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application

Intervention Type DRUG

Carbamide Peroxide 10%

Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days

Intervention Type DRUG

Other Intervention Names

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Group 1 - HP 6% Group 2 - HP 15% Group 3 - CP 10%

Eligibility Criteria

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Inclusion Criteria

* tooth color ranging from A3 or darker, teeth with no stains and restorations without whitening experience

Exclusion Criteria

* participants with gingivitis and periodontal disease, the total biofilm accumulation greater than 30%, severe crowding dental, smoking with tooth sensitivity and pregnant women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Cláudia Silami de Magalhães

Associate Professor IV, Department of Restorative Dentistry at the Federal University of Minas Gerais

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nayara Kelly Lyrio Ferraz

Role: PRINCIPAL_INVESTIGATOR

PhD student of Federal University of Minas Gerais

Locations

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Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Martin J, Vildosola P, Bersezio C, Herrera A, Bortolatto J, Saad JR, Oliveira OB Jr, Fernandez E. Effectiveness of 6% hydrogen peroxide concentration for tooth bleaching-A double-blind, randomized clinical trial. J Dent. 2015 Aug;43(8):965-72. doi: 10.1016/j.jdent.2015.05.011. Epub 2015 Jun 6.

Reference Type BACKGROUND
PMID: 26057085 (View on PubMed)

Meireles SS, Goettems ML, Dantas RV, Bona AD, Santos IS, Demarco FF. Changes in oral health related quality of life after dental bleaching in a double-blind randomized clinical trial. J Dent. 2014 Feb;42(2):114-21. doi: 10.1016/j.jdent.2013.11.022. Epub 2013 Dec 4.

Reference Type BACKGROUND
PMID: 24316342 (View on PubMed)

Other Identifiers

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FUMinasGerais01

Identifier Type: -

Identifier Source: org_study_id

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