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

NCT07279662 | Completed

• 1 other identifier: AUDHF-FM-ALT-RAMEC-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Malocclusion; Skeletal Malocclusion; Maxillary Deficiency

Keywords

Face Mask Therapy; Growing Patients; Cephalometric Evaluation; Class III Orthodontic Treatment; Maxillary Protraction; Alt-RAMEC Protocol; Zygomatic Buttress Miniscrew; Miniscrew Anchorage; Skeletal Anchorage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in A-Point to Vertical Reference Distance (A-Tvert.)

  From baseline to 10 months

Study Arms (2)

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.

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.

Device: Skeletal Anchorage Supported Maxillary Protraction

Interventions

Skeletal Anchorage Supported Maxillary Protraction 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.

Conventional Face Mask Group (Appliance/FM)

Tooth-Borne Maxillary Protraction Appliance 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.

Skeletal Anchorage Face Mask Group (Miniscrew/FM)

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murat Kaan Erdem: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, Yenimahalle, 06590, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III; Retrognathia

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatment providers and participants could not be masked due to the nature of orthodontic appliances.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, DDS

Model Details: Participants were randomly assigned to one of two parallel treatment groups: skeletal anchorage-supported face mask therapy or conventional tooth-borne face mask therapy.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 12, 2025
• Study Start: January 5, 2023
• Primary Completion: September 5, 2024
• Study Completion: October 5, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)