Angle Class IINCT06011382
Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®)
A study testing Advanced Molar Distalization Appliance (amda®) and Buccal mini-implants in people with Angle Class II, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Angle Class II
- What is being tested?
- Advanced Molar Distalization Appliance (amda®) and Buccal mini-implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRomania
- Study dates
- 20 Jun 2022to 20 Jun 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients to have permanent dentition
- with or without the 2nd molar erupted
- bilateral Class II molar relationships (a quarter to 1 molar cusp).
Who cannot join
- Past orthodontic treatment
- crossbites,
- severe carious lesions,
- poor oral hygiene,
- mobility of the maxillary first molars,
- anterior open bites,
- vertical growth pattern,
- tongue habits.
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy "Grigore T. Popa"
Iași, 70015
UMF Grigore T. Popa, +40759481645, karvelas93@gmail.com
Nikolaos Karvelas, PhD student
About this study
Official title: Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.
Read the detailed description
The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of:
- Group I: patients treated with amda®
- Group II: patients treated with buccal mini-implants
More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points:
- point T0: baseline data - before initiation of the treatment
- point T1: immediately after distalization (8-12 months)
- Conditions
- Angle Class II
- Being tested
- Advanced Molar Distalization Appliance (amda®), Buccal mini-implants
- Keywords
- amda®, maxillary molar distalization, randomized controlled trial, orthodontics
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Molar Distalization Appliance (amda®)Device
AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization
Buccal mini-implantsDevice
Buccal mini-implants for maxillary molar distalization
| Study group | Role | What they receive |
|---|---|---|
| patients treated with amda® | Active comparator | two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization. Receives: Device: Advanced Molar Distalization Appliance (amda®) |
| patients treated with buccal mini-implants | Active comparator | from initiation of treatment until completion of maxillary molar distalization. Receives: Device: Buccal mini-implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteroposterior position changes of upper first molars.
Anteroposterior position movement in mm of the upper first molars
Measured: 8-12 months
Measurements on the lateral cephalograms and digital 3D model casts.
Angular measurements of the lateral cephalograms and digital models
Measured: 8-12 months
Measurements on the lateral cephalograms and digital 3D model casts.
Linear measurements of the lateral cephalograms and digital models
Measured: 8-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start20 Jun 2022
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class IIStudies 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
- Two arm parallel randomized controlled trial with 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Nikolaos Karvelas, Grigore T. Popa University of Medicine and Pharmacy
- Investigators
- Nikolaos Karvelas, PhD student, Principal investigator, Grigore T Popa University, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011382
- Sponsor's protocol ID
- NKarvelas
- Status last verified
- Aug 2023
- First submitted
- 13 Jun 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be availaible upon request
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06011382
- Acronym / sponsor ID
- NKarvelas
- Conditions
- Angle Class II
- Keywords
- amda®, maxillary molar distalization, randomized controlled trial, orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Aristotle University Of Thessaloniki
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 25 Aug 2023 (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 randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.
Detailed description
The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of:
- Group I: patients treated with amda®
- Group II: patients treated with buccal mini-implants
More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points:
- point T0: baseline data - before initiation of the treatment
- point T1: immediately after distalization (8-12 months)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm parallel randomized controlled trial with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| patients treated with amda® | Active comparator | Device: Advanced Molar Distalization Appliance (amda®)two different treatment groups will be evaluated, from initiation of treatment until completion of maxillary molar distalization. |
| patients treated with buccal mini-implants | Active comparator | Device: Buccal mini-implantsfrom initiation of treatment until completion of maxillary molar distalization. |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- All patients to have permanent dentition
- with or without the 2nd molar erupted
- bilateral Class II molar relationships (a quarter to 1 molar cusp).
Key exclusion criteria (8 listed)
- Past orthodontic treatment
- crossbites,
- severe carious lesions,
- poor oral hygiene,
- mobility of the maxillary first molars,
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 |
|---|---|---|
| Advanced Molar Distalization Appliance (amda®)AMDA is a prefabricated device anchored to the palate by miniscrews and it is a noncompliance appliance for maxillary molar distalization | Device | patients treated with amda® |
| Buccal mini-implantsBuccal mini-implants for maxillary molar distalization | Device | patients treated with buccal mini-implants |
Primary outcome
Anteroposterior position changes of upper first molars.
Time frame: 8-12 months
Anteroposterior position movement in mm of the upper first molars
Measurements on the lateral cephalograms and digital 3D model casts.
Time frame: 8-12 months
Angular measurements of the lateral cephalograms and digital models
Measurements on the lateral cephalograms and digital 3D model casts.
Time frame: 8-12 months
Linear measurements of the lateral cephalograms and digital models
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No. The data will be availaible upon request
Related trials for Angle Class II
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Malocclusion, Angle Class II, Malocclusion, Angle Class III
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Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
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Malocclusion Class II, Malocclusion, Angle Class I
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.
Nikolaos Karvelas, PhD student principal investigator
Grigore T Popa University, Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Molar Distalization Appliance (amda®) and Buccal mini-implants in people with Angle Class II, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 8 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. 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 Romania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikolaos Karvelas, PhD student (+40 759481645, karvelas93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anteroposterior position changes of upper first molars. (time frame: 8-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2023.