Endocrine DisruptorsNCT06685029
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
A study testing Clear aligner treatment and Fixed Orthodontic Appliance Treatment in people with Endocrine Disruptors, run by Ahmet Yağcı at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Endocrine Disruptors
- What is being tested?
- Clear aligner treatment and Fixed Orthodontic Appliance Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
Show all 13Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University,Faculty of Dentistry,Department of Orthodontics
Kayseri, 38000
About this 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
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.
Read the 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
- Being tested
- Clear aligner treatment, Fixed Orthodontic Appliance Treatment
- Keywords
- Bisphenol A, Clear Aligners, Direct Production.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear aligner treatmentDevice
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 Appliance TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dİrect In-House Aligner Group | Experimental | Patients in this group are treated with clear aligners produced directly by the clinician. The physical model production step is eliminated with direct production technique.Intraoral scan images were obtained from these patients with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device. Then, the 3D scan images were transferred to the Maestro 3D Dental Studio (New Age, Pisa, Italy) computer software. Using these scan images, the teeth were gradually moved according to the planned final treatment result. The number of clear paligners required is calculated by the program according to the total amount of planned tooth movement. Then, Tera Harz TC-85DAC (Graphy, Seoul, Korea) resin and Asiga MAX UV (Asiga, Sydney, Australia) 3D printer were used for the direct production of the plates designed in the program. The aligners produced were then delivered to the patients. Receives: Device: Clear aligner treatment |
| Invisalign Group | Experimental | Intraoral scan images were obtained with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device from patients who would receive Invisalign (Align Technology, Santa Clara, CA) clear aligners. These 3D intraoral scan images, together with the intraoral and extraoral photographs, radiographic records, and clinical examination findings obtained from the patients, were uploaded to the cloud software 'ClinCheck' for Invisalign . Necessary instructions were written regarding the patients' treatment plans. Afterwards, patient specific 3D treatment simulations sent to the clinician by the companies were reviewed and the necessary revisions were made. The final accepted treatment plan was approved and the aligners were produced by the relevant companies and sent to the clinic.The clear aligners produced are delivered to the patients and treatment started. Receives: Device: Clear aligner treatment |
| ClearCorrect Group | Experimental | Intraoral scan images were obtained with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device from patients who would receive Invisalign (Align Technology, Santa Clara, CA) and ClearCorrect (ClearCorrect®, Round Rock, TX, USA) clear aligners. These 3D intraoral scan images, together with the intraoral and extraoral photographs, radiographic records, and clinical examination findings obtained from the patients, were uploaded to the cloud software 'ClinCheck' for Invisalign . Necessary instructions were written regarding the patients' treatment plans. Afterwards, patient specific 3D treatment simulations sent to the clinician by the companies were reviewed and the necessary revisions were made. The final accepted treatment plan was approved and the aligners were produced by the relevant companies and sent to the clinic.The clear aligners produced are delivered to the patients and treatment started. Receives: Device: Clear aligner treatment |
| Fixed Orthodontic Treatment Group | Experimental | In the fixed orthodontic treatment group, all tooth surfaces to which brackets would be bonded were etched with 37% phosphoric acid (dline Phosphoric Acid Etching Gel UAB, Medicinos linij Karaliauciaus str. 29 LT-78348 Siauliai Lithuania) for 30 seconds, then bond (3M Unitek Transbond XT, Minnesota, U.S.A.) was applied and light was applied to all teeth separately for 5 seconds with a light device (Valo Cordless curing light Ultradent Products, Inc. 505 W. Ultradent Drive (10200 South) South Jordan, UT 84095) [165, 166]. Afterwards, composite (3M Unitek Transbond XT, Minnesota, U.S.A.) was applied to the base of the metal brackets (AO Mini Master Roth 018, Altenhofstrasse 80, 66386 St. Ingbert, Germany) and after it was placed on the tooth surface and the composite residues around the bracket were cleaned, light was applied for 5 seconds for each bracket. Then, arch wires were applied and the fixed orthodontic treatment of the patients was started. Receives: Device: Fixed Orthodontic Appliance Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bisphenol A Concentration
Bisphenol A concentration in patients' saliva is measured as ng/ml.
Measured: up to 1 year
Secondary outcomes (2)
Treatment efficiency
The total time required to complete the treatment is calculated.
Measured: up to 1 year
Treatment Effectiveness (via PAR İndex)
The percentage decrease in the PAR score is calculated for each group.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Oct 2023
- Primary completion12 Dec 2024
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endocrine DisruptorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Yağcı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Yağcı, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685029
- Sponsor's protocol ID
- TDH-2024-13280
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32221494Iliadi 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.
PubMed 32295303Raghavan 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.
PubMed 28257731Yazdi 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.
PubMed 37180685
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06685029
- Acronym / sponsor ID
- TDH-2024-13280
- Conditions
- Endocrine Disruptors
- Keywords
- Bisphenol A, Clear Aligners, Direct Production.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ahmet YağcıUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dİrect In-House Aligner Group | Experimental | Device: Clear aligner treatmentPatients in this group are treated with clear aligners produced directly by the clinician. The physical model production step is eliminated with direct production technique.Intraoral scan images were obtained from these patients with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device. Then, the 3D scan images were transferred to the Maestro 3D Dental Studio (New Age, Pisa, Italy) computer software. Using these scan images, the teeth were gradually moved according to the planned final treatment result. The number of clear paligners required is calculated by the program according to the total amount of planned tooth movement. Then, Tera Harz TC-85DAC (Graphy, Seoul, Korea) resin and Asiga MAX UV (Asiga, Sydney, Australia) 3D printer were used for the direct production of the plates designed in the program. The aligners produced were then delivered to the patients. |
| Invisalign Group | Experimental | Device: Clear aligner treatmentIntraoral scan images were obtained with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device from patients who would receive Invisalign (Align Technology, Santa Clara, CA) clear aligners. These 3D intraoral scan images, together with the intraoral and extraoral photographs, radiographic records, and clinical examination findings obtained from the patients, were uploaded to the cloud software 'ClinCheck' for Invisalign . Necessary instructions were written regarding the patients' treatment plans. Afterwards, patient specific 3D treatment simulations sent to the clinician by the companies were reviewed and the necessary revisions were made. The final accepted treatment plan was approved and the aligners were produced by the relevant companies and sent to the clinic.The clear aligners produced are delivered to the patients and treatment started. |
| ClearCorrect Group | Experimental | Device: Clear aligner treatmentIntraoral scan images were obtained with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device from patients who would receive Invisalign (Align Technology, Santa Clara, CA) and ClearCorrect (ClearCorrect®, Round Rock, TX, USA) clear aligners. These 3D intraoral scan images, together with the intraoral and extraoral photographs, radiographic records, and clinical examination findings obtained from the patients, were uploaded to the cloud software 'ClinCheck' for Invisalign . Necessary instructions were written regarding the patients' treatment plans. Afterwards, patient specific 3D treatment simulations sent to the clinician by the companies were reviewed and the necessary revisions were made. The final accepted treatment plan was approved and the aligners were produced by the relevant companies and sent to the clinic.The clear aligners produced are delivered to the patients and treatment started. |
| Fixed Orthodontic Treatment Group | Experimental | Device: Fixed Orthodontic Appliance TreatmentIn the fixed orthodontic treatment group, all tooth surfaces to which brackets would be bonded were etched with 37% phosphoric acid (dline Phosphoric Acid Etching Gel UAB, Medicinos linij Karaliauciaus str. 29 LT-78348 Siauliai Lithuania) for 30 seconds, then bond (3M Unitek Transbond XT, Minnesota, U.S.A.) was applied and light was applied to all teeth separately for 5 seconds with a light device (Valo Cordless curing light Ultradent Products, Inc. 505 W. Ultradent Drive (10200 South) South Jordan, UT 84095) [165, 166]. Afterwards, composite (3M Unitek Transbond XT, Minnesota, U.S.A.) was applied to the base of the metal brackets (AO Mini Master Roth 018, Altenhofstrasse 80, 66386 St. Ingbert, Germany) and after it was placed on the tooth surface and the composite residues around the bracket were cleaned, light was applied for 5 seconds for each bracket. Then, arch wires were applied and the fixed orthodontic treatment of the patients was started. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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°),
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear aligner treatmentClear 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 | ClearCorrect Group, Dİrect In-House Aligner Group, Invisalign Group |
| Fixed Orthodontic Appliance TreatmentFixed 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. | Device | Fixed Orthodontic Treatment Group |
Primary outcome
Bisphenol A Concentration
Time frame: up to 1 year
Bisphenol A concentration in patients' saliva is measured as ng/ml.
2 secondary outcomes
Treatment efficiency
Time frame: up to 1 year
Treatment Effectiveness (via PAR İndex)
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 32221494Kassam 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.
- Background: PubMed 32295303Iliadi 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.
- Background: PubMed 28257731Raghavan 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.
- Background: PubMed 37180685Yazdi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear aligner treatment and Fixed Orthodontic Appliance Treatment in people with Endocrine Disruptors, run by Ahmet Yağcı at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bisphenol A Concentration (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06685029, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.