CClinicalTrials.gg
CompletedNCT06716827Updated Dec 4, 2024

Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners

An interventional study of In-office bleaching system and Laser-assisted bleaching in Tooth Discoloration, sponsored by Ahmet Yağcı. Completed at 1 site in Turkey. Open to participants aged 16 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Ahmet Yağcı · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Nov 2022, registered Nov 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
16 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Discoloration

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Keywords

  • Clear aligner treatment
  • Bleaching
  • Home bleaching
03

In context

Tooth Discoloration

102 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 56 is above the median of 48 across 95 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Ahmet Yağcı is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • ProcedureIn-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.

  • ProcedureLaser-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.

  • ProcedureHome-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.

  • OtherControl

    This group of patients did not undergo any whitening procedures.

06

What researchers measure

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.

    Time frame: up to 1,5 years

Secondary outcomes

  1. QLF(Quantitative light-induced fluorescence) Analysis Score

    Delta F (ΔF) - The percentage of fluorescence loss relative to a sound tooth

    Time frame: up to 1 years

07

Study locations

1 site
  • Erciyes University, Faculty of Dentistry, Department of Orthodontics
    Kayseri, 38000, Turkey
08

References and documents

Publications

  • 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. PubMed 24352384 ↗
  • 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. PubMed 10507207 ↗
  • 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. PubMed 32354432 ↗
  • 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. PubMed 21724070 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06716827
Lead sponsor
Ahmet Yağcı
Collaborators
TC Erciyes University
Responsible party
Ahmet Yağcı (PROFESSOR, TC Erciyes University) — Sponsor-investigator
First posted
Dec 4, 2024
Start date
Nov 9, 2022
Primary completion
Sep 1, 2024
Completion
Nov 9, 2024
Last update
Dec 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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