Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color

April 17, 2019 updated by: André Luis Faria e Silva

Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SE
      • Aracaju, SE, Brazil, 49060100
        • Universidade Federal de Sergipe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Bleaching Agents
In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
Drug: Bleaching Agents
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.
Active Comparator: At-home bleaching
The teeth will be bleached only with customized trays filled with 10% carbamide peroxide and used for 1h per day.
Drug: Bleaching Agents
In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
Drug: Bleaching Agents
At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to tooth color satisfaction
Time Frame: up to 1 month after beginning the tooth bleaching procedures
Time in days performing at-home bleaching necessary to participant reports that is satisfied with the tooth color obtained
up to 1 month after beginning the tooth bleaching procedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Color change
Time Frame: up to 1 month after beginning the tooth bleaching procedures
Values of delta E measured with a spectrophotometer from color at baseline
up to 1 month after beginning the tooth bleaching procedures
Tooth sensitivity
Time Frame: 1, 2, 3, and 4 week after beginning the tooth bleaching procedures
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.
1, 2, 3, and 4 week after beginning the tooth bleaching procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

André Luis Faria e Silva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Combined bleaching

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe