Clinical trial NCT06716827: Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners
Official title: Comparison of Different Teeth Bleaching Methods Performed During Fixed and Clear Aligner Orthodontic Treatments: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Discoloration
Keywords: Clear aligner treatment
Bleaching
Home bleaching
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2024-12-04
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tooth color measurement
timeFrame: up to 1,5 years
Secondary outcomes:
measure: QLF(Quantitative light-induced fluorescence) Analysis Score
timeFrame: up to 1 years
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University, Faculty of Dentistry, Department of Orthodontics
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.