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Completed

NCT Number: NCT06716827

Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners

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.

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Key information

Conditions

Tooth Discoloration Stomatognathic Diseases Tooth Diseases

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University, Faculty of Dentistry, Department of Orthodontics

Kayseri, 38000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-office bleaching system

Procedure

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.

Laser-assisted bleaching

Procedure

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.

Home-bleaching

Procedure

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.

Control

Other

This group of patients did not undergo any whitening procedures.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ahmet Yağcı

Other

Collaborators

  • TC Erciyes University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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