NCT06685029

A Comparison of Direct 3D Printed Clear Aligner System and Indirect Clear Aligner Systems With Fixed Orthodontic Treatment in Terms of Endocrine Disrupting Monomer Release, Treatment Effectiveness and Efficiency

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Ahmet Yağcı · Academic / Other
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Not accepted

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 treatment effectiveness and efficiency.

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 effectivenes and total time spent . 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.

Conditions

• Endocrine Disruptors

Interventions

Type	Name	Description
DEVICE	Clear aligner treatment	Clear aligners are appliances that allow the teeth to be gradually moved to the desired final position, as planned in the computer program, in a way that each aligner will perform a part of the total movement with its use.
DEVICE	Fixed Orthodontic Appliance Treatment	Fixed orthodontic treatment is a type of orthodontic treatment performed by applying brackets and wires to the teeth and is considered the gold standard for orthodontic treatments.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-12-12
• Completion: 2025-02-18
• First posted: 2024-11-12
• Last updated: 2025-09-25

Locations

1 site across 1 country: Turkey (Türkiye)