Clinical trial NCT06685029: Endocrine Disrupting Monomer Release in Clear Aligner Systems and Fixed Orthodontic Treatment: a Randomized Controlled Clinical Study
Official title: Comparison of Clear Aligner System Produced Directly by the Orthodontist and Indirect Clear Aligner Systems with Fixed Orthodontic Treatment in Terms of Endocrine Disrupting Monomer Release: In-vivo Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endocrine Disruptors
Keywords: Bisphenol A, Clear Aligners, Direct Production.
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty two patients were divided into 4 groups at our study: Group A - Direct In-House Aligner, Group B - Invisalign group, Group C - Clear Correct group, Group D - Fixed Orthodontic Treatment group. Digital models will be obtained from the patients included in our study. In addition, QLF records will be collected from patients at the beginning and end of treatment and saliva samples will be taken at different times of treatment. These saliva samples will be analyzed for Bisphenol A content. The groups will also be compared for the development of white spot lesions. The total treatment time of patients receiving clear aligner treatment and fixed orthodontic treatment will be measured. Treatment effectiveness will be evaluated by scoring digital 3D models taken from patients with the PAR (Peer Assessment Rating) index.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the release of endocrine disrupting monomers from clear aligners as a result of exposure to intraoral factors by measuring their concentration in saliva and to evaluate their reliability of use in terms of general health by comparing them with the fixed orthodontic treatment group. It is also aimed to compare the groups in terms of total treatment duration, treatment effectiveness and white spot lesion formation.

Detailed description: The aim of our study is to evaluate the saliva concentration of endocrine-disrupting monomers released from attachments used and clear aligners produced directly by the orthodontist in the clinic and indirectly produced by companies. Accordingly comparing them with the fixed orthodontic treatment group and assessing clear aligner's safety for general health. It is also aimed to compare the groups in terms of treatment time spent, treatment effectiveness and white spot lesion formation. Endocrine-disrupting chemicals are substances that interfere with the synthesis, metabolism, or effects of hormones, causing deviation from normal reproduction and homeostatic control in organisms. Bisphenol A (BPA), a monomer, is also included in the chemicals listed as endocrine disruptors by the World Health Organization. Different studies have suggested that Bisphenol A may cause adverse health effects by acting as an endocrine disruptor. While previous research has been conducted on BPA release or monomer leakage related to orthodontic materials, there is limited evidence regarding the safety aspects of thermoplastic aligners or retainers. The concentrations of endocrine-disrupting monomers in the saliva of patients undergoing treatment with directly produced aligners by orthodontists and indirectly produced aligners by companies will be examined in comparison to patients undergoing fixed orthodontic treatment. Patients will not receive any treatment other than routine orthodontic care.

Eligibility criteria: Inclusion Criteria:

* Absence of primary teeth in the oral cavity, with permanent teeth fully erupted,
* Presence of a non-extraction orthodontic treatment plan,
* Age range of 15 to 24 years,
* Presence of mild to moderate dental crowding (0-6 mm of crowding),
* Classification as skeletal Class I (ANB: 2±2°),
* Absence of any craniofacial anomalies,
* Normal vertical growth pattern (Sn-GoGn: 32±6°),
* No congenital tooth agenesis (excluding third molars),
* Absence of atypical tooth morphology,
* No extracted permanent teeth,
* Absence of dental caries,
* Good level of oral hygiene,
* Healthy periodontal tissues.

Exclusion Criteria:

* Presence of any systemic disease,
* History of previous fixed orthodontic treatment,
* History of allergy to any dental material,
* Use of medications containing estrogen analogs,
* Patients with a history of xerostomia and a salivary flow rate of less than 0.1 ml per minute,
* Patients with more than five composite restorations.

Primary outcomes:
measure: Bisphenol A Concentration
timeFrame: up to 1 year
Secondary outcomes:
measure: Treatment Duration
timeFrame: up to 1 year
measure: PAR(Peer Assessment Rating) Score
timeFrame: up to 1 year
measure: QLF(Quantitative light-induced fluorescence) Analysis Score
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University,Faculty of Dentistry,Department of Orthodontics
Study officials:
References:
citation: Kassam SK, Stoops FR. Are clear aligners as effective as conventional fixed appliances? Evid Based Dent. 2020 Mar;21(1):30-31. doi: 10.1038/s41432-020-0079-5.
citation: Iliadi A, Koletsi D, Papageorgiou SN, Eliades T. Safety Considerations for Thermoplastic-Type Appliances Used as Orthodontic Aligners or Retainers. A Systematic Review and Meta-Analysis of Clinical and In-Vitro Research. Materials (Basel). 2020 Apr 14;13(8):1843. doi: 10.3390/ma13081843.
citation: Raghavan AS, Pottipalli Sathyanarayana H, Kailasam V, Padmanabhan S. Comparative evaluation of salivary bisphenol A levels in patients wearing vacuum-formed and Hawley retainers: An in-vivo study. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):471-476. doi: 10.1016/j.ajodo.2016.07.022.
citation: Yazdi M, Daryanavard H, Ashtiani AH, Moradinejad M, Rakhshan V. A systematic review of biocompatibility and safety of orthodontic clear aligners and transparent vacuum-formed thermoplastic retainers: Bisphenol-A release, adverse effects, cytotoxicity, and estrogenic effects. Dent Res J (Isfahan). 2023 Mar 28;20:41. eCollection 2023.