Comparison of Skeletal Anchorage Versus Conventional Tooth-Borne Face Mask Therapy Following the Alt-RAMEC Protocol (MiniFM)

Murat Kaan Erdem

Status: Completed

Conditions: Class III Malocclusion; Skeletal Malocclusion; Maxillary Deficiency

Treatments: Device: Tooth-Borne Maxillary Protraction Appliance; Device: Skeletal Anchorage Supported Maxillary Protraction

Study type: Interventional

Funder types: Other

Identifiers

NCT07279662

AUDHF-FM-ALT-RAMEC-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Skeletal Anchorage Face Mask Group (Miniscrew/FM)

Experimental group

Description:

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.

Treatment:

Device: Tooth-Borne Maxillary Protraction Appliance

Conventional Face Mask Group (Appliance/FM)

Active Comparator group

Description:

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.

Treatment:

Device: Skeletal Anchorage Supported Maxillary Protraction