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Tooth DiscolorationNCT06716827

Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners

A study testing In-office bleaching system, Laser-assisted bleaching and Home-bleaching in people with Tooth Discoloration, run by Ahmet Yağcı at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 16 to 30 years
Conditions the study is for
Tooth Discoloration
What is being tested?
In-office bleaching system, Laser-assisted bleaching and Home-bleaching
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Nov 2022to 9 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Erciyes University, Faculty of Dentistry, Department of Orthodontics

    Kayseri, 38000

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

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.

Being tested
In-office bleaching system, Laser-assisted bleaching, Home-bleaching, Control
Keywords
Clear aligner treatment, Bleaching, Home bleaching
Medical subject headings
Tooth Discoloration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-office bleaching systemProcedure or surgery

    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 bleachingProcedure or surgery

    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-bleachingProcedure or surgery

    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.

  • ControlOther

    This group of patients did not undergo any whitening procedures.

Study groups in NCT06716827
Study groupRoleWhat they receive
ConventionalExperimentalIn 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.
Receives: Procedure: In-office bleaching system
Laser-assisted bleachingExperimentalIn 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).
Receives: Procedure: Laser-assisted bleaching
Home bleachingExperimentalIn 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).
Receives: Procedure: Home-bleaching
ControlExperimentalThe 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.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 1,5 years

Secondary outcomes (1)

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

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

    Measured: up to 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start9 Nov 2022
  3. Primary completion1 Sep 2024
  4. Study completion9 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716827
Sponsor's protocol ID
TDK-2023-12793
Status last verified
Nov 2024
First submitted
26 Nov 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing In-office bleaching system, Laser-assisted bleaching and Home-bleaching in people with Tooth Discoloration, run by Ahmet Yağcı at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tooth color measurement (time frame: up to 1,5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716827, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.

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