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

Primary Purpose

Discolored Teeth

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
hydrogen peroxide 6%
hydrogen peroxide 15%
Carbamide Peroxide 10%
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discolored Teeth focused on measuring carbamide peroxide, Hydrogen peroxide, Quality of life

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Minas Gerais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1 - HP 6%

Group 2 - HP 15%

Group 3 - CP 10%

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tooth sensitivity assessment
It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe.
Evaluation of gingival irritation
The Modified Gingival Index (IGM) The criteria are as follows: 0: Absence of inflammation;1: mild inflammation - slight change in color and texture of the gum; 2: mild inflammation involving the entire gingival margin; 3: moderate inflammation, shiny surface and edema; 4: Severe inflammation, spontaneous bleeding and severe edema.
Impact assessment on quality of life
The Brazilian version of the oral impact on daily performance (OIDP) will be used to assess the impact on quality of life. The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4) to assess the perception of changes in oral health after treatment.

Full Information

First Posted
June 21, 2016
Last Updated
February 8, 2018
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT02816593
Brief Title
In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.
Official Title
In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.: Effectiveness, Security and Impact on Quality of Life Related to Oral Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discolored Teeth
Keywords
carbamide peroxide, Hydrogen peroxide, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - HP 6%
Arm Type
Experimental
Arm Description
Group 1: Experimental: Office; hydrogen peroxide 6%,
Arm Title
Group 2 - HP 15%
Arm Type
Experimental
Arm Description
Group 2: Experimental: Office; hydrogen peroxide 15%,
Arm Title
Group 3 - CP 10%
Arm Type
Active Comparator
Arm Description
Group 3: Control: Homemade; Carbamide Peroxide 10%,
Intervention Type
Drug
Intervention Name(s)
hydrogen peroxide 6%
Other Intervention Name(s)
Group 1 - HP 6%
Intervention Description
Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application
Intervention Type
Drug
Intervention Name(s)
hydrogen peroxide 15%
Other Intervention Name(s)
Group 2 - HP 15%
Intervention Description
Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application
Intervention Type
Drug
Intervention Name(s)
Carbamide Peroxide 10%
Other Intervention Name(s)
Group 3 - CP 10%
Intervention Description
Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days
Primary Outcome Measure Information:
Title
Evaluation of color change
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Tooth sensitivity assessment
Description
It will be registered according to the Visual Analogue Scale (VAS), according to the criteria: none, mild, moderate or severe.
Time Frame
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;
Title
Evaluation of gingival irritation
Description
The Modified Gingival Index (IGM) The criteria are as follows: 0: Absence of inflammation;1: mild inflammation - slight change in color and texture of the gum; 2: mild inflammation involving the entire gingival margin; 3: moderate inflammation, shiny surface and edema; 4: Severe inflammation, spontaneous bleeding and severe edema.
Time Frame
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;
Title
Impact assessment on quality of life
Description
The Brazilian version of the oral impact on daily performance (OIDP) will be used to assess the impact on quality of life. The instrument will be applied in interview form at two different times at baseline (T0) and thirty days after the first evaluation (T4) to assess the perception of changes in oral health after treatment.
Time Frame
T0 (Baseline): Before treatment;T4: After 30 days of starting treatment;

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayara Kelly Lyrio Ferraz
Organizational Affiliation
PhD student of Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26057085
Citation
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.
Results Reference
background
PubMed Identifier
24316342
Citation
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.
Results Reference
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In-office and At-home Tooth Bleaching Using Low Concentration Peroxides.

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