DistalizationNCT07040176
Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.
A study testing Upper molar distalization in people with Distalization and Class II Malocclusion, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners… Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Distalization, Class II Malocclusion, Aligner Therapy
- What is being tested?
- Upper molar distalization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 10 Apr 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with at least half cusp bilateral Class II malocclusion between upper and lower first molars due to maxillary excess or maxillary protrusion or forward movement of the maxillary posterior teeth, where maxillary molar distalization is indicated.
- Patients in the permanent dentition period of less than 30 years of age with second molars erupted at least one half.
- Patients with good general health and healthy periodontium.
Who cannot join
- Patients with Class II malocclusion between upper and lower first molars due to mandibular deficiency or mandibular retrusion.
- Patients with less than half cusp bilateral Class II malocclusion between upper and lower first molars.
- Patients with unilateral Class II malocclusion between upper and lower first molars.
- Patients with cleft lip and palate or with other craniofacial syndromes.
- Patients with missing, or congenital missing or supernumerary teeth.
- Patients with full coverage molar restorations.
- Patients with previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Orthodontics, Faculty of Dentistry, School of Medical Sciences, Aristotle University of Thessaloniki
Thessaloniki, 54124
Aikaterini Samandara, Doctor of Dental Surgery, +30694529980, katerinasamandara@gmail.com
Aikaterini Samandara, Doctor of Dental Surgery
About this study
Official title: Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners: A Randomized Clinical Trial.
The goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics.
The main questions it aims to answer are:
Read more
Is there any difference in achieving upper molar distalization with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants and with clear aligners (Spark®) supported by Class II elastics at the end of active distalization phase?
Is there any difference between the two groups in the anchorage loss at the end of total treatment?
Additionally, the differences in the movements of premolars, canines and incisors will be analyzed in all three planes of space (sagittal, transverse, vertical), as well as the duration of treatment between the two groups and subgroup comparisons will be performed regarding age, gender, presence of maxillary third molars and severity of malocclusion.
Participants will be randomly assigned to the AMDA® or Spark® group. Treatment will take place at the Department of Orthodontics and participants will have to visit the clinic every 4-6 weeks for regular check ups. Intraoral scans, photographs and x-rays (panoramic x-ray, cephalometric x-rays) will be taken before treatment, at the end of active distalization phase and at the end of treatment.
Read the detailed description
The aim of the study is to compare distalization of maxillary first and second molars achieved with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics. All patients will be randomly assigned into two groups:
- Group I (AMDA®) consisting of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian.
- Group II (Spark®) consisting of patients that will be treated with clear aligners for both molar distalization and anterior teeth retraction.
Lateral cephalometric radiographs of the patients' heads and three-dimensional (3D) intraoral scans of the maxillary and mandibular arches will be taken:
- before treatment (T1),
- at the end of active distalization (T2), (active distalization will be completed, when first and second molars will achieve a full Class I molar relationship (not a super-Class I), and
- at the end of treatment (T3).
Cone Beam Computed Tomography (CBCT) dental scans will be taken in patients assigned to the AMDA group:
- before treatment (T1),
- after miniscrew implant insertion (Tm) CBCT dental scans in T1 will be taken for the 3D evaluation of the anterior palate and the fabrication of a surgical guide for miniscrew implant placement. CBCT dental scans in Tm will verify accuracy of miniscrew implant placement, as well as the existence of enough clearance between miniscrew implants and the roots of upper anterior teeth to ensure a safe retraction of these teeth without the risk of contacting the miniscrew implants and the resulting root resorptions. All CBCT dental scans will be taken in a certified private dental x-ray laboratory.
Completion of orthodontic treatment of all patients will be accomplished when Class I molar and canine relationships, normal overjet and overbite, a good leveling and alignment of the teeth, and a tight occlusion of the posterior teeth will be achieved.
In all these three time points the corresponding 2D and 3D analysis will include:
- angular and linear measurements of the cephalometric analysis,
- angular and linear measurements of the virtual dental casts analysis,
- two-dimensional (2D) superimpositions of the cephalometric tracings, as well as
- 3D superimpositions of the intraoral scans of the maxillary and mandibular arches.
- superimposition of CBCT scans
All patients will be treated in the Postgraduate Clinic of the Department of Orthodontics at the Aristotle University of Thessaloniki by the applicant (Mrs. Samandara) under the supervision of Professor Papadopoulos. Assistance will be provided by the postgraduate students after insertion of the appliance, during the follow up appointments for checking and re-activating the appliances.
- Being tested
- Upper molar distalization
- Keywords
- Class II malocclusion, Distalization, Orthodontics, Aligners, Miniscrew implants
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper molar distalizationProcedure or surgery
This study aims to compare upper molar distalization movement achieved with a non-compliance miniscrew implant supported appliance (AMDA®) with distalization of upper molars achieved with clear aligners (Spark®) supported by Class II elastics.
| Study group | Role | What they receive |
|---|---|---|
| AMDA® (Advanced Molar Distalization Appliance) | Active comparator | The AMDA arm consists of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian. Receives: Procedure: Upper molar distalization |
| Spark® | Active comparator | The Spark® arm consists of patients that will be treated with clear aligners and elastics for both molar distalization and anterior teeth retraction. Receives: Procedure: Upper molar distalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars.
Measured: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.
Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.
Measured: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars.
Measured: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.
Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.
Measured: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Secondary outcomes (2)
Duration of active distalization phase
Comparison of the duration of active distalization between the two approaches (AMDA® and Spark®).
Measured: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, at the end of distalization phase (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Duration of total treatment
Comparison of the duration of total treatment between the two approaches (AMDA® and Spark®).
Measured: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start10 Apr 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
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 DistalizationStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katerina Samandara-Bouzani, Aristotle University Of Thessaloniki
- Investigators
- Moschos Papadopoulos, Professor, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040176
- Sponsor's protocol ID
- protoc.numb. 21/14-12-2023
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD (Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code will be shared.
Publications
Wilmes B, Drescher D. Application and effectiveness of the Beneslider: a device to move molars distally. World J Orthod. 2010 Winter;11(4):331-40.
PubMed 21490998Ravera S, Castroflorio T, Garino F, Daher S, Cugliari G, Deregibus A. Maxillary molar distalization with aligners in adult patients: a multicenter retrospective study. Prog Orthod. 2016;17:12. doi: 10.1186/s40510-016-0126-0. Epub 2016 Apr 18.
PubMed 27041551Papadopoulos MA, Melkos AB, Athanasiou AE. Noncompliance maxillary molar distalization with the first class appliance: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 May;137(5):586.e1-586.e13; discussion 586-7. doi: 10.1016/j.ajodo.2009.10.033.
PubMed 20451774Antonarakis GS, Kiliaridis S. Maxillary molar distalization with noncompliance intramaxillary appliances in Class II malocclusion. A systematic review. Angle Orthod. 2008 Nov;78(6):1133-40. doi: 10.2319/101507-406.1.
PubMed 18947282
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07040176
- Acronym / sponsor ID
- protoc.numb. 21/14-12-2023
- Keywords
- Class II malocclusion, Distalization, Orthodontics, Aligners, Miniscrew implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Jun 2025 (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 goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics.
The main questions it aims to answer are:
Is there any difference in achieving upper molar distalization with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants and with clear aligners (Spark®) supported by Class II elastics at the end of active distalization phase?
Is there any difference between the two groups in the anchorage loss at the end of total treatment?
Additionally, the differences in the movements of premolars, canines and incisors will be analyzed in all three planes of space (sagittal, transverse, vertical), as well as the duration of treatment between the two groups and subgroup comparisons will be performed regarding age, gender, presence of maxillary third molars and severity of malocclusion.
Participants will be randomly assigned to the AMDA® or Spark® group. Treatment will take place at the Department of Orthodontics and participants will have to visit the clinic every 4-6 weeks for regular check ups. Intraoral scans, photographs and x-rays (panoramic x-ray, cephalometric x-rays) will be taken before treatment, at the end of active distalization phase and at the end of treatment.
Detailed description
The aim of the study is to compare distalization of maxillary first and second molars achieved with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics. All patients will be randomly assigned into two groups:
- Group I (AMDA®) consisting of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian.
- Group II (Spark®) consisting of patients that will be treated with clear aligners for both molar distalization and anterior teeth retraction.
Lateral cephalometric radiographs of the patients' heads and three-dimensional (3D) intraoral scans of the maxillary and mandibular arches will be taken:
- before treatment (T1),
- at the end of active distalization (T2), (active distalization will be completed, when first and second molars will achieve a full Class I molar relationship (not a super-Class I), and
- at the end of treatment (T3).
Cone Beam Computed Tomography (CBCT) dental scans will be taken in patients assigned to the AMDA group:
- before treatment (T1),
- after miniscrew implant insertion (Tm) CBCT dental scans in T1 will be taken for the 3D evaluation of the anterior palate and the fabrication of a surgical guide for miniscrew implant placement. CBCT dental scans in Tm will verify accuracy of miniscrew implant placement, as well as the existence of enough clearance between miniscrew implants and the roots of upper anterior teeth to ensure a safe retraction of these teeth without the risk of contacting the miniscrew implants and the resulting root resorptions. All CBCT dental scans will be taken in a certified private dental x-ray laboratory.
Completion of orthodontic treatment of all patients will be accomplished when Class I molar and canine relationships, normal overjet and overbite, a good leveling and alignment of the teeth, and a tight occlusion of the posterior teeth will be achieved.
In all these three time points the corresponding 2D and 3D analysis will include:
- angular and linear measurements of the cephalometric analysis,
- angular and linear measurements of the virtual dental casts analysis,
- two-dimensional (2D) superimpositions of the cephalometric tracings, as well as
- 3D superimpositions of the intraoral scans of the maxillary and mandibular arches.
- superimposition of CBCT scans
All patients will be treated in the Postgraduate Clinic of the Department of Orthodontics at the Aristotle University of Thessaloniki by the applicant (Mrs. Samandara) under the supervision of Professor Papadopoulos. Assistance will be provided by the postgraduate students after insertion of the appliance, during the follow up appointments for checking and re-activating the appliances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMDA® (Advanced Molar Distalization Appliance) | Active comparator | Procedure: Upper molar distalizationThe AMDA arm consists of patients that will be treated initially for molar distalization with a miniscrew implant supported device (AMDA®) and for anterior teeth retraction (after molar distalization) with the same device and fixed appliances. The miniscrew implants will be inserted in the anterior region of the palate, especially 6-9 mm posterior to the incisive foramen and 3-6 mm paramedian. |
| Spark® | Active comparator | Procedure: Upper molar distalizationThe Spark® arm consists of patients that will be treated with clear aligners and elastics for both molar distalization and anterior teeth retraction. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with at least half cusp bilateral Class II malocclusion between upper and lower first molars due to maxillary excess or maxillary protrusion or forward movement of the maxillary posterior teeth, where maxillary molar distalization is indicated.
- Patients in the permanent dentition period of less than 30 years of age with second molars erupted at least one half.
- Patients with good general health and healthy periodontium.
Key exclusion criteria (7 listed)
- Patients with Class II malocclusion between upper and lower first molars due to mandibular deficiency or mandibular retrusion.
- Patients with less than half cusp bilateral Class II malocclusion between upper and lower first molars.
- Patients with unilateral Class II malocclusion between upper and lower first molars.
- Patients with cleft lip and palate or with other craniofacial syndromes.
- Patients with missing, or congenital missing or supernumerary teeth.
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 |
|---|---|---|
| Upper molar distalizationThis study aims to compare upper molar distalization movement achieved with a non-compliance miniscrew implant supported appliance (AMDA®) with distalization of upper molars achieved with clear aligners (Spark®) supported by Class II elastics. | Procedure or surgery | AMDA® (Advanced Molar Distalization Appliance), Spark® |
Primary outcome
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
Time frame: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars.
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.
Time frame: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Cephalometric analysis performed in lateral x-rays and cast analysis performed in intraoral scans will provide us with linear measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.
Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved).
Time frame: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars.
Angular measurements for anteroposterior changes of maxillary first molar distalization movement at the end of total orthodontic treatment.
Time frame: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Cephalometric analysis performed in lateral x-rays will provide us with angular measurements assessing the anteroposterior movement of maxillary first molars at the end of orthodontic treatment.
2 secondary outcomes
Duration of active distalization phase
Time frame: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, at the end of distalization phase (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).
Duration of total treatment
Time frame: T1: Baseline records, (initial records before the beginning of treatment). T3: End of treatment records (records taken at the end of orthodontic treatment after removal of all orthodontic appliances), an average of 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Background: PubMed 21490998Wilmes B, Drescher D. Application and effectiveness of the Beneslider: a device to move molars distally. World J Orthod. 2010 Winter;11(4):331-40.
- Background: PubMed 27041551Ravera S, Castroflorio T, Garino F, Daher S, Cugliari G, Deregibus A. Maxillary molar distalization with aligners in adult patients: a multicenter retrospective study. Prog Orthod. 2016;17:12. doi: 10.1186/s40510-016-0126-0. Epub 2016 Apr 18.
- Background: PubMed 20451774Papadopoulos MA, Melkos AB, Athanasiou AE. Noncompliance maxillary molar distalization with the first class appliance: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 May;137(5):586.e1-586.e13; discussion 586-7. doi: 10.1016/j.ajodo.2009.10.033.
- Background: PubMed 18947282Antonarakis GS, Kiliaridis S. Maxillary molar distalization with noncompliance intramaxillary appliances in Class II malocclusion. A systematic review. Angle Orthod. 2008 Nov;78(6):1133-40. doi: 10.2319/101507-406.1.
- Individual participant dataSharing planned: Yes. All collected IPD (Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code will be shared.
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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.
Moschos Papadopoulos, Professor study chair
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper molar distalization in people with Distalization and Class II Malocclusion, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Jun 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aikaterini Samandara, Doctor of Dental Surgery (+306945299800, katerinasamandara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear measurements for anteroposterior changes of maxillary first molar distalization movement at the end of active distalization (until Class I molar relationship is achieved). (time frame: T1: Baseline records (initial records before the beginning of treatment). T2: 8-12 months, end of distalization phase records (records taken at the end of upper molar distalization, when upper first molars will be bilaterally in Class I malocclusion).). The study lists 4 primary outcomes in all. 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 NCT07040176, 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 27 Jun 2025.