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

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.

Study Overview

• Status: Completed
• Conditions: Class III Malocclusion; Maxillary Deficiency; Skeletal Malocclusion
• Intervention / Treatment: Device: Tooth-Borne Maxillary Protraction Appliance; Device: Skeletal Anchorage Supported Maxillary Protraction

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06590
      • Ankara University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 10 months

Collaborators and Investigators

• Sponsor: Murat Kaan Erdem

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): October 5, 2024

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Growing Patients; Skeletal Anchorage; Face Mask Therapy; Cephalometric Evaluation; Class III Orthodontic Treatment; Maxillary Protraction; Alt-RAMEC Protocol; Zygomatic Buttress Miniscrew; Miniscrew Anchorage
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Tooth Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Malocclusion; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retrognathia; Malocclusion, Angle Class III
• Other Study ID Numbers: AUDHF-FM-ALT-RAMEC-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the dataset includes identifiable cephalometric imaging and clinical information from pediatric participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No