Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners

November 29, 2024 updated by: Ahmet Yağcı

Comparison of Different Teeth Bleaching Methods Performed During Fixed and Clear Aligner Orthodontic Treatments: A Randomized Controlled Clinical Trial

The aim of this study is to compare the effectiveness of different whitening methods used during orthodontic treatment with fixed appliances and clear aligners. It also aims to examine the effect of different whitening methods on white spot lesions and the color change they cause in the teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During orthodontic treatment, if oral hygiene is not properly maintained or in long-term treatments, tooth discoloration may occur. In clear aligner treatment, failure to regularly clean the aligners or the consumption of staining foods and beverages while wearing the aligners can lead to staining and yellowing of the tooth surfaces.

The aim of this study is to compare the effectiveness of different whitening methods used during orthodontic treatment with fixed appliances and clear aligners. It also aims to examine the effect of different whitening methods on white spot lesions using quantitative light-induced fluorescence (QLF) and to evaluate the color changes in the teeth during the treatment process.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

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

  • Turkey
      • Kayseri, Turkey, 38000
        • Erciyes University, Faculty of Dentistry, Department of Orthodontics

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • No previous orthopedic or orthodontic treatment
  • Mild or moderate malocclusion
  • Non-smokers and non-alcohol consumers
  • Consumes no more than 3 cups of tea or coffee per day
  • Good oral hygiene and healthy periodontal tissues
  • No cavities, restorations, pigmentation, or white spot lesions on the anterior teeth
  • Chronological age between 16-30 years, regardless of bone age

Exclusion Criteria:

  • Individuals requiring extraction-based treatment
  • Individuals who have previously undergone whitening treatment
  • Individuals with endogenous tooth discoloration
  • Individuals with genetic tooth pigmentation
  • Individuals in the mixed dentition phase

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional
In this group, 14 patients (7 with fixed appliances and 7 with clear aligners) underwent conventional whitening procedures during the treatment process. As the whitening agent, an in-office bleaching system containing 35% hydrogen peroxide (Whiteness HP, FGM) was chosen.
Procedure: In-office bleaching system
As the whitening agent, an in-office bleaching system containing 35% hydrogen peroxide (Whiteness HP, FGM) was chosen. The gingiva was isolated using an isolation material (Opaldam, Ultradent Products Inc.), which was light-cured with a standard curing light. The whitening gel was applied to the labial surfaces of the maxillary incisors and canines with a 1mm thickness and left for 20 minutes. After cleaning the teeth with an aspiration tip, the whitening procedure was repeated.
Experimental: Laser-assisted bleaching
In this group, 14 patients (7 with fixed appliances and 7 with clear aligners) underwent laser whitening with a 940 nm diode laser and a 35% hydrogen peroxide gel (Whiteness HP, FGM).
Procedure: Laser-assisted bleaching
Whitening was performed 10 days prior to treatment, with laser treatment applied without removing brackets in the fixed appliance group and without cleaning attachments in the aligner group. The laser was applied to the buccal surface of the teeth with a 1mm distance for 30 seconds in three applications. After a 10-minute rest, the laser procedure was repeated.
Experimental: Home bleaching
In the home whitening group, 14 patients (7 with fixed appliances and 7 with clear aligners) underwent a 14-day home whitening treatment during the treatment process using a 16% carbamide peroxide gel (Opalescence PF, Ultradent Products Inc., South Jordan, UT, USA).
Procedure: Home-bleaching
The whitening trays were custom-made for the fixed appliance patients, and they used them for 2-4 hours each evening after brushing their teeth. In the transparent aligner group, whitening was done using the aligners worn for treatment.
Experimental: Control
The 14 patients randomly selected (7 with fixed appliances and 7 with clear aligners) served as the control group. No whitening procedures were performed on the patients in this group.
Other: Control
This group of patients did not undergo any whitening procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth color measurement
Time Frame: up to 1,5 years
The screenshots of the scanning records taken at the beginning and end of the treatment were captured, and the L*, a*, b* values were measured using Photoshop software.
up to 1,5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QLF(Quantitative light-induced fluorescence) Analysis Score
Time Frame: up to 1 years
Delta F (ΔF) - The percentage of fluorescence loss relative to a sound tooth
up to 1 years

Collaborators and Investigators

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

Sponsor

Ahmet Yağcı

Collaborators

TC Erciyes University

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)

November 9, 2022

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

November 9, 2024

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDK-2023-12793

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

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.

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