An interventional study of Skeletal Anchorage Supported Maxillary Protraction and Tooth-Borne Maxillary Protraction Appliance in Class III Malocclusion, Skeletal Malocclusion and Maxillary Deficiency, sponsored by Murat Kaan Erdem. Completed at 1 site in Turkey (Türkiye). Open to participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Murat Kaan Erdem · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 40 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Murat Kaan Erdem is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Tooth-Borne Maxillary Protraction Appliance
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.
Device: Skeletal Anchorage Supported Maxillary Protraction
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.
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.
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.
Time frame: From baseline to 10 months
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.
Time frame: From baseline to 10 months
Plan to share: 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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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →
Murat Kaan Erdem