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

NCT ID: NCT07279662

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2024-10-05

Brief 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. 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.

Conditions

Class III Malocclusion; Skeletal Malocclusion; Maxillary Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Skeletal Anchorage Face Mask Group (Miniscrew/FM)

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.

Group Type: EXPERIMENTAL

Tooth-Borne Maxillary Protraction Appliance

Intervention Type: DEVICE

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.

Conventional Face Mask Group (Appliance/FM)

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.

Group Type: ACTIVE_COMPARATOR

Skeletal Anchorage Supported Maxillary Protraction

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Tooth-Borne Maxillary Protraction Appliance

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Murat Kaan Erdem

OTHER

Sponsor Role: lead

Responsible Party

Murat Kaan Erdem

PhD, DDS

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ankara University Faculty of Dentistry

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AUDHF-FM-ALT-RAMEC-2025

Identifier Type: -

Identifier Source: org_study_id