CompletedNot Applicable

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

Turkey (Türkiye)52 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

15 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bisphenol A Concentration

Timeframe: up to 1 year

Trial details

NCT IDNCT06685029

SponsorAhmet Yağcı

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-12

View on ClinicalTrials.gov More Endocrine Disruptors trials