NCT02816593

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

June 21, 2016

Last Update Submit

February 8, 2018

Conditions

Discolored Teeth

Keywords

carbamide peroxideHydrogen peroxideQuality of life

Outcome Measures

Primary Outcomes (1)

  • Evaluation of color change

    Visual evaluation using color scale Vita Classical 3D Master (Vita Zahnfabrik, Germany); (B1, A1, B2, D2, A2, C1, C2, D4, A3, D3, B3, A3.5, B4, C3, A4, C4) Quantitative evaluation using a spectrophotometer Easy Shade Advance ® (Wilcos Brazil). System CIE L \* a \* b \* - L represents the value (lightness or darkness), the value of a \* is a measure red (positive a \*) or green (negative a \*); the value of b \* is a yellow extent (b \* positive) or blue (b \* negative) and the color difference between the color coordinate is calculated as ΔE \* = \[(ΔL \*) 2 + (Δa \*) 2 + (Δb \*) 2\] 1/2.

    T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months ;T6:After 12 months

Secondary Outcomes (3)

  • Tooth sensitivity assessment

    T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;

  • Evaluation of gingival irritation

    T0 (Baseline): Before treatment;T1:After one week of starting treatment;T2: After 2 weeks of starting treatment;T3: After 3 weeks of starting treatment;T4: After 30 days of starting treatment;

  • Impact assessment on quality of life

    T0 (Baseline): Before treatment;T4: After 30 days of starting treatment;

Study Arms (3)

Group 1 - HP 6%

EXPERIMENTAL

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

Drug: hydrogen peroxide 6%

Group 2 - HP 15%

EXPERIMENTAL

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

Drug: hydrogen peroxide 15%

Group 3 - CP 10%

ACTIVE COMPARATOR

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

Drug: Carbamide Peroxide 10%

Interventions

hydrogen peroxide 6%DRUG

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

Also known as: Group 1 - HP 6%
Group 1 - HP 6%
hydrogen peroxide 15%DRUG

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

Also known as: Group 2 - HP 15%
Group 2 - HP 15%
Carbamide Peroxide 10%DRUG

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

Also known as: Group 3 - CP 10%
Group 3 - CP 10%

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 26057085BACKGROUND

  • 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.

    PMID: 24316342BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Nayara Kelly Lyrio Ferraz

    PhD student of Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor IV, Department of Restorative Dentistry at the Federal University of Minas Gerais

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 28, 2016

Study Start

August 1, 2015

Primary Completion

July 1, 2017

Study Completion

February 1, 2018

Last Updated

February 12, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)