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Comparison of Ertty Gap III and Facemask Therapy for Skeletal Class III Correction

NCT07771660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-08-18

No results posted yet for this study

Summary

This clinical study compared two orthopedic treatment approaches for growing patients with skeletal Class III malocclusion associated primarily with maxillary deficiency: the Ertty Gap III appliance and facemask therapy. Participants assigned to active treatment received either Ertty Gap III or facemask therapy, while an untreated historical Class III group was used as a reference for growth-related changes. The main objective was to compare the skeletal effects of the two treatment approaches, particularly changes in the sagittal relationship between the maxilla and mandible. Dentoalveolar, vertical skeletal, and soft tissue changes were also evaluated. Lateral cephalometric radiographs obtained before treatment and after correction of the anterior crossbite and achievement of a positive overjet were used for the assessments.

Conditions

  • Skeletal Class III Malocclusion

Interventions

DEVICE

Ertty Gap III Appliance

The Ertty Gap III appliance is an intraoral orthopedic appliance designed for maxillary protraction in growing patients with skeletal Class III malocclusion. The maxillary component consists of a sagittally oriented 90° inverted Hyrax expansion screw with an acrylic pad extending from the palatal rugae toward the premaxillary region and posterior occlusal build-ups. The mandibular component consists of a lip bumper-lingual arch assembly supported by the mandibular first permanent molars. Bilateral 5/16-inch, 8-ounce Class III intermaxillary elastics are applied between the maxillary first-molar region and the mandibular lip-bumper notches. The sagittal Hyrax screw is activated once weekly with two consecutive quarter-turns. Patients are instructed to wear the appliance and intermaxillary elastics full time, except during meals, oral hygiene, and contact sports. Patients are monitored at 4-week intervals.

DEVICE

Facemask Therapy

Conventional maxillary protraction was performed using a Petit-type facemask in combination with a 0.80-mm full-coverage vacuum-formed maxillary splint covering all maxillary teeth. Hooks were incorporated into the splint in the premolar region for attachment of bilateral protraction elastics. Maxillary expansion was not performed in order to isolate the effects of maxillary protraction. Bilateral protraction elastics delivered approximately 350 g of force per side, with the force vector directed approximately 30° downward from the occlusal plane. The applied force was verified using a force gauge at appliance delivery and at each follow-up visit. Participants were instructed to wear the facemask and elastics full time except during meals, oral hygiene, and contact sports. Follow-up visits were scheduled at 4-week intervals to assess appliance integrity, reinforce compliance, verify elastic force levels, and make necessary adjustments.

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • Ayse T Altug, DDS, PhD, Professor · Ankara University, Faculty of Dentistry, Department of Orthodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-10
Primary Completion
2025-12-09
Completion
2025-12-09

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771660 on ClinicalTrials.gov