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Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

Primary Purpose

Tooth Discoloration

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Bleaching Agents
Bleaching Agents
Sponsored by
André Luis Faria e Silva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring Tooth bleaching, Hydrogen peroxide, Carbamide peroxide, Tooth Bleaching Agents

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de Sergipe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined technique

At-home bleaching

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Time to tooth color satisfaction
Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained

Secondary Outcome Measures

Color change
Values of delta E measured with a spectrophotometer from color at baseline
Tooth sensitivity
Maximum level of tooth sensitivity reported by participants using an analogue visual scale. The distance between the patient's marking and the no pain border was recorded in cm.

Full Information

First Posted
April 13, 2018
Last Updated
April 17, 2019
Sponsor
André Luis Faria e Silva
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1. Study Identification

Unique Protocol Identification Number
NCT03514797
Brief Title
Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color
Official Title
Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
André Luis Faria e Silva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration
Keywords
Tooth bleaching, Hydrogen peroxide, Carbamide peroxide, Tooth Bleaching Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined technique
Arm Type
Experimental
Arm Description
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.
Arm Title
At-home bleaching
Arm Type
Active Comparator
Arm Description
The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day.
Intervention Type
Drug
Intervention Name(s)
Bleaching Agents
Intervention Description
In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
Intervention Type
Drug
Intervention Name(s)
Bleaching Agents
Intervention Description
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.
Primary Outcome Measure Information:
Title
Time to tooth color satisfaction
Description
Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained
Time Frame
up to 1 month after beginning the tooth bleaching procedures
Secondary Outcome Measure Information:
Title
Color change
Description
Values of delta E measured with a spectrophotometer from color at baseline
Time Frame
up to 1 month after beginning the tooth bleaching procedures
Title
Tooth sensitivity
Description
Maximum level of tooth sensitivity reported by participants using an analogue visual scale. The distance between the patient's marking and the no pain border was recorded in cm.
Time Frame
1, 2, 3, and 4 week after beginning the tooth bleaching procedures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidade Federal de Sergipe
City
Aracaju
State/Province
SE
ZIP/Postal Code
49060100
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26919081
Citation
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.
Results Reference
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PubMed Identifier
20884923
Citation
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.
Results Reference
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Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

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