Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners

NCT06716827 | Completed

• 1 other identifier: TDK-2023-12793
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Discoloration

Keywords

Clear aligner treatment; Bleaching; Home bleaching

Outcome Measures

Primary Outcomes (1)

• Tooth color measurement

  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 Outcomes (1)

• QLF(Quantitative light-induced fluorescence) Analysis Score

  up to 1 years

Study Arms (4)

Conventional

EXPERIMENTAL

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

Laser-assisted bleaching

EXPERIMENTAL

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

Home bleaching

EXPERIMENTAL

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

Control

EXPERIMENTAL

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

Interventions

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.

Conventional

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.

Laser-assisted bleaching

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.

Home bleaching

Control OTHER

This group of patients did not undergo any whitening procedures.

Control

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahmet Yağcı: lead
• TC Erciyes University: collaborator

Study Sites (1)

Erciyes University, Faculty of Dentistry, Department of Orthodontics

Kayseri, 38000, Turkey (Türkiye)

Location

Related Publications (4)

• Consolaro A, Consolaro RB, Francischone L. Clarifications, guidelines and questions about the dental bleaching "associated" with orthodontic treatment. Dental Press J Orthod. 2013 Sep-Oct;18(5):4-10. doi: 10.1590/s2176-94512013000500002.

  PMID: 24352384 RESULT

• Hegedus C, Bistey T, Flora-Nagy E, Keszthelyi G, Jenei A. An atomic force microscopy study on the effect of bleaching agents on enamel surface. J Dent. 1999 Sep;27(7):509-15. doi: 10.1016/s0300-5712(99)00006-8.

  PMID: 10507207 RESULT

• Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.

  PMID: 32354432 RESULT

• Jadad E, Montoya J, Arana G, Gordillo LA, Palo RM, Loguercio AD. Spectrophotometric evaluation of color alterations with a new dental bleaching product in patients wearing orthodontic appliances. Am J Orthod Dentofacial Orthop. 2011 Jul;140(1):e43-7. doi: 10.1016/j.ajodo.2010.11.021.

  PMID: 21724070 RESULT

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: November 9, 2022
• Primary Completion: September 1, 2024
• Study Completion: November 9, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)