Endocrine Disrupting Monomer Release in Clear Aligner Systems and Fixed Orthodontic Treatment: a Randomized Controlled Clinical Study

Not Applicable

Active, not recruiting

• Conditions: Endocrine Disruptors

• Registration Number: NCT06685029
• Lead Sponsor: Ahmet Yağcı

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.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bisphenol A Concentration	up to 1 year	Bisphenol A concentration in patients' saliva is measured as ng/ml.

Secondary Outcome Measures

Name	Time	Method
Treatment Duration	up to 1 year	The total time required to complete the treatment is calculated.
PAR(Peer Assessment Rating) Score	up to 1 year	The percentage decrease in the PAR score is calculated.
QLF(Quantitative light-induced fluorescence) Analysis Score	up to 1 year	Delta F (ΔF) - The percentage of fluorescence loss relative to a sound tooth tissue, Delta F maximum (ΔFmax)- The loss of maximum fluorescence intensity throughout the entire range, Delta Q (ΔQ)- The multiplication of the lesion area by the percentage of loss of fluorescence relative to intact tooth tissue; Lesion area (WS) (px2)- ΔF equal to or lower than a specific threshold value (5% by default) values measured.

Trial Locations

Locations (1)

Erciyes University,Faculty of Dentistry,Department of Orthodontics; 🇹🇷 Kayseri, Turkey