Endocrine Disruptors
Conditions
Keywords
Bisphenol A, Clear Aligners, Direct Production.
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 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.
Interventions
DEVICEClear 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.
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.
Sponsors
Ahmet Yağcı
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Fifty two patients were divided into 4 groups at 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 study. In addition, 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bisphenol A Concentration | up to 1 year | Bisphenol A concentration in patients' saliva is measured as ng/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficiency | up to 1 year | The total time required to complete the treatment is calculated. |
| Treatment Effectiveness (via PAR İndex) | up to 1 year | The percentage decrease in the PAR score is calculated for each group. |
Countries
Turkey (Türkiye)
Outcome results
None listed