Class III MalocclusionMiniFMNCT07279662
Comparison of Skeletal Anchorage Versus Conventional Tooth-Borne Face Mask Therapy Following the Alt-RAMEC Protocol
A study testing Skeletal Anchorage Supported Maxillary Protraction and Tooth-Borne Maxillary Protraction Appliance in people with Class III Malocclusion and Skeletal Malocclusion, run by Murat Kaan Erdem at 1 site in Turkey (Türkiye).
Trial summary
This study investigated two different methods of maxillary protraction in growing patients with skeletal Class III malocclusion characterized by maxillary deficiency. All participants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol to mobilize the circummaxillary sutures. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Class III Malocclusion, Skeletal Malocclusion, Maxillary Deficiency
- What is being tested?
- Skeletal Anchorage Supported Maxillary Protraction and Tooth-Borne Maxillary Protraction Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 5 Oct 2024
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 7 and 13 years.
- Skeletal Class III malocclusion with maxillary retrognathia (ANB < 0°).
- Normal or increased vertical growth pattern (SN-GoGn < 39°).
- Retrusive nasomaxillary region and/or upper lip.
- Good oral hygiene.
- No contraindication for orthodontic treatment.
- Written informed consent obtained from parents/guardians.
Who cannot join
- Systemic diseases or conditions affecting bone metabolism.
- Craniofacial syndromes or congenital anomalies.
- Functional Class III due to habitual occlusal interference.
- Previous orthodontic or orthopedic treatment.
- Severe mandibular prognathism without maxillary involvement.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Yenimahalle, 06590
About this study
Official title: Comparative Study on the Effects of Conventional and Skeletal Anchorage Supported Face Mask Applications on Dentofacial Structures Following the Alt-RAMEC Protocol
This study investigated two different methods of maxillary protraction in growing patients with skeletal Class III malocclusion characterized by maxillary deficiency. All participants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol to mobilize the circummaxillary sutures. Following this, maxillary protraction was performed using either skeletal anchorage with miniscrews placed in the zygomatic buttress region or a conventional tooth-borne rapid maxillary expansion appliance. Cephalometric radiographs were taken before treatment, after the Alt-RAMEC protocol, and after completion of face mask therapy to evaluate skeletal and dentoalveolar changes. The study aimed to determine whether skeletal anchorage provides greater maxillary advancement and reduced dental side effects compared to conventional tooth-borne anchorage.
Read the detailed description
Skeletal Class III malocclusion with maxillary deficiency can negatively affect facial profile, occlusal function, and craniofacial growth. Early orthopedic intervention may help redirect growth and improve skeletal relationships. The Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol has been introduced to enhance maxillary protraction by promoting greater disarticulation of the circummaxillary sutures.
In this prospective study, participants were randomly assigned to one of two treatment groups. Both groups used the same sequence of Alt-RAMEC activation over approximately seven weeks. In the skeletal anchorage group, miniscrews (2×11 mm) were placed in the zygomatic buttress region to directly apply orthopedic forces to the maxilla. In the conventional group, protraction forces were applied from hooks on a tooth-borne maxillary expansion appliance. In both groups, face mask therapy was performed with approximately 400 g of bilateral force applied at a 30-degree angle to the occlusal plane, worn 18-20 hours per day until a positive overjet was achieved.
Standardized lateral cephalometric radiographs were obtained at three time points: before treatment, after completion of the Alt-RAMEC protocol, and after completion of face mask therapy. Skeletal and dentoalveolar measurements were used to assess treatment effects. Primary outcomes focused on the forward movement of the maxilla, while secondary outcomes evaluated maxillary incisor inclination, molar position, mandibular rotations, and overjet correction.
This study aimed to clarify whether skeletal anchorage results in greater skeletal maxillary advancement and reduced dental compensation compared with conventional tooth-borne anchorage during facemask therapy in growing Class III patients.
- Being tested
- Skeletal Anchorage Supported Maxillary Protraction, Tooth-Borne Maxillary Protraction Appliance
- Keywords
- Face Mask Therapy, Growing Patients, Cephalometric Evaluation, Class III Orthodontic Treatment, Maxillary Protraction, Alt-RAMEC Protocol, Zygomatic Buttress Miniscrew, Miniscrew Anchorage, Skeletal Anchorage
- Medical subject headings
- Malocclusion, Angle Class III, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal Anchorage Supported Maxillary ProtractionDevice
Maxillary protraction using skeletal anchorage placed in the zygomatic buttress region following the Alt-RAMEC protocol. Two 2×11 mm miniscrews were inserted under local anesthesia, and protraction elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were attached to the face mask. Patients were instructed to wear the face mask for 18-20 hours per day until a positive overjet was achieved.
Tooth-Borne Maxillary Protraction ApplianceDevice
Maxillary protraction performed using a Hyrax-type tooth-borne expansion appliance equipped with anterior hooks after completion of the Alt-RAMEC protocol. Face mask elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were attached to the appliance. Patients were instructed to wear the face mask for 18-20 hours per day until a positive overjet was achieved.
| Study group | Role | What they receive |
|---|---|---|
| Skeletal Anchorage Face Mask Group (Miniscrew/FM) | Experimental | Participants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol followed by maxillary protraction using skeletal anchorage. Two 2×11 mm miniscrews were placed in the zygomatic buttress region to directly apply orthopedic force to the maxilla. Face mask elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were worn 18-20 hours per day until a positive overjet was achieved. Receives: Device: Tooth-Borne Maxillary Protraction Appliance |
| Conventional Face Mask Group (Appliance/FM) | Active comparator | Participants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol followed by maxillary protraction using a tooth-borne Hyrax expansion appliance with hooks for force application. Face mask elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were worn 18-20 hours per day until a positive overjet was achieved. Receives: Device: Skeletal Anchorage Supported Maxillary Protraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SNA Angle
The SNA angle measures the sagittal position of the maxilla relative to the cranial base. An increase in this value indicates forward movement of the maxilla. The change in SNA (in degrees) will be compared within each group and between treatment groups.
Measured: From baseline to 10 months
Secondary outcomes (1)
Change in A-Point to Vertical Reference Distance (A-Tvert.)
A-Tvert. measures the sagittal position of Point A relative to a vertical craniofacial reference plane. An increase in this distance indicates forward movement of the maxilla. The change will be compared within groups and between treatment groups to assess the skeletal effect of protraction.
Measured: From baseline to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start5 Jan 2023
- Primary completion5 Sep 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class III MalocclusionStudies 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
- Participants were randomly assigned to one of two parallel treatment groups: skeletal anchorage-supported face mask therapy or conventional tooth-borne face mask therapy.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murat Kaan Erdem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murat Kaan Erdem, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279662
- Sponsor's protocol ID
- AUDHF-FM-ALT-RAMEC-2025
- Acronym
- MiniFM
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset includes identifiable cephalometric imaging and clinical information from pediatric participants.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Effects of Conventional and Skeletal Anchorage Supported Face Mask Applications on Dentofacial Structures Following the Alt-RAMEC Protocol
- ClinicalTrials.gov ID
- NCT07279662
- Acronym / sponsor ID
- MiniFM / AUDHF-FM-ALT-RAMEC-2025
- Keywords
- Face Mask Therapy, Growing Patients, Cephalometric Evaluation, Class III Orthodontic Treatment, Maxillary Protraction, Alt-RAMEC Protocol, Zygomatic Buttress Miniscrew, Miniscrew Anchorage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Murat Kaan ErdemUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 12 Dec 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.
This study investigated two different methods of maxillary protraction in growing patients with skeletal Class III malocclusion characterized by maxillary deficiency. All participants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol to mobilize the circummaxillary sutures. Following this, maxillary protraction was performed using either skeletal anchorage with miniscrews placed in the zygomatic buttress region or a conventional tooth-borne rapid maxillary expansion appliance. Cephalometric radiographs were taken before treatment, after the Alt-RAMEC protocol, and after completion of face mask therapy to evaluate skeletal and dentoalveolar changes. The study aimed to determine whether skeletal anchorage provides greater maxillary advancement and reduced dental side effects compared to conventional tooth-borne anchorage.
Detailed description
Skeletal Class III malocclusion with maxillary deficiency can negatively affect facial profile, occlusal function, and craniofacial growth. Early orthopedic intervention may help redirect growth and improve skeletal relationships. The Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol has been introduced to enhance maxillary protraction by promoting greater disarticulation of the circummaxillary sutures.
In this prospective study, participants were randomly assigned to one of two treatment groups. Both groups used the same sequence of Alt-RAMEC activation over approximately seven weeks. In the skeletal anchorage group, miniscrews (2×11 mm) were placed in the zygomatic buttress region to directly apply orthopedic forces to the maxilla. In the conventional group, protraction forces were applied from hooks on a tooth-borne maxillary expansion appliance. In both groups, face mask therapy was performed with approximately 400 g of bilateral force applied at a 30-degree angle to the occlusal plane, worn 18-20 hours per day until a positive overjet was achieved.
Standardized lateral cephalometric radiographs were obtained at three time points: before treatment, after completion of the Alt-RAMEC protocol, and after completion of face mask therapy. Skeletal and dentoalveolar measurements were used to assess treatment effects. Primary outcomes focused on the forward movement of the maxilla, while secondary outcomes evaluated maxillary incisor inclination, molar position, mandibular rotations, and overjet correction.
This study aimed to clarify whether skeletal anchorage results in greater skeletal maxillary advancement and reduced dental compensation compared with conventional tooth-borne anchorage during facemask therapy in growing Class III patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel treatment groups: skeletal anchorage-supported face mask therapy or conventional tooth-borne face mask therapy.
| Arm | Type | Receives |
|---|---|---|
| Skeletal Anchorage Face Mask Group (Miniscrew/FM) | Experimental | Device: Tooth-Borne Maxillary Protraction ApplianceParticipants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol followed by maxillary protraction using skeletal anchorage. Two 2×11 mm miniscrews were placed in the zygomatic buttress region to directly apply orthopedic force to the maxilla. Face mask elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were worn 18-20 hours per day until a positive overjet was achieved. |
| Conventional Face Mask Group (Appliance/FM) | Active comparator | Device: Skeletal Anchorage Supported Maxillary ProtractionParticipants underwent the Alternate Rapid Maxillary Expansion and Constriction (Alt-RAMEC) protocol followed by maxillary protraction using a tooth-borne Hyrax expansion appliance with hooks for force application. Face mask elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were worn 18-20 hours per day until a positive overjet was achieved. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age between 7 and 13 years.
- Skeletal Class III malocclusion with maxillary retrognathia (ANB < 0°).
- Normal or increased vertical growth pattern (SN-GoGn < 39°).
- Retrusive nasomaxillary region and/or upper lip.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Systemic diseases or conditions affecting bone metabolism.
- Craniofacial syndromes or congenital anomalies.
- Functional Class III due to habitual occlusal interference.
- Previous orthodontic or orthopedic treatment.
- Severe mandibular prognathism without maxillary involvement.
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 |
|---|---|---|
| Skeletal Anchorage Supported Maxillary ProtractionMaxillary protraction using skeletal anchorage placed in the zygomatic buttress region following the Alt-RAMEC protocol. Two 2×11 mm miniscrews were inserted under local anesthesia, and protraction elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were attached to the face mask. Patients were instructed to wear the face mask for 18-20 hours per day until a positive overjet was achieved. | Device | Conventional Face Mask Group (Appliance/FM) |
| Tooth-Borne Maxillary Protraction ApplianceMaxillary protraction performed using a Hyrax-type tooth-borne expansion appliance equipped with anterior hooks after completion of the Alt-RAMEC protocol. Face mask elastics delivering approximately 400 g of bilateral force at a 30° downward angle to the occlusal plane were attached to the appliance. Patients were instructed to wear the face mask for 18-20 hours per day until a positive overjet was achieved. | Device | Skeletal Anchorage Face Mask Group (Miniscrew/FM) |
Primary outcome
Change in SNA Angle
Time frame: From baseline to 10 months
The SNA angle measures the sagittal position of the maxilla relative to the cranial base. An increase in this value indicates forward movement of the maxilla. The change in SNA (in degrees) will be compared within each group and between treatment groups.
1 secondary outcome
Change in A-Point to Vertical Reference Distance (A-Tvert.)
Time frame: From baseline to 10 months
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 12 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset includes identifiable cephalometric imaging and clinical information from pediatric participants.
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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 Skeletal Anchorage Supported Maxillary Protraction and Tooth-Borne Maxillary Protraction Appliance in people with Class III Malocclusion and Skeletal Malocclusion, run by Murat Kaan Erdem 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 7 inclusion and 5 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 12 Dec 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?
Change in SNA Angle (time frame: From baseline to 10 months). 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 12 Dec 2025.