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Comparative 3D Assessment of Class III Malocclusion Treatments

NCT07179354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-09-23

No results posted yet for this study

Summary

This clinical trial compares three different treatment methods used to correct jaw problems in children with Class III malocclusion (a condition where the lower jaw is positioned forward relative to the upper jaw). The treatments include:

Rapid maxillary expansion with face mask (RME/FM),

Mini maxillary protractor (MMP),

Modified splints with elastics and chin cup (SEC III).

The study aims to understand how each treatment affects the bones and soft tissues of the face, such as how much the upper jaw moves forward or the lower jaw moves backward, as well as changes in teeth alignment and facial appearance. Results showed that different treatments work best for different aspects: some are better for moving the upper jaw forward, while others are better for repositioning the lower jaw. This information helps doctors choose the most suitable treatment plan for each patient.

Conditions

  • Class III Skeletal Malocclusion

Interventions

DEVICE

Rapid Maxillary Expansion with Face Mask (RME/FM)

A tooth- and tissue-borne rapid maxillary expansion appliance with an expansion screw was used to achieve transverse maxillary expansion, followed by Petit-type face mask therapy. Expansion protocol: two quarter-turns per day for 10-14 days, then one quarter-turn per day until cusp-to-cusp relationship was achieved. Face mask elastics applied 16 hours/day at 350-500 g per side, with a 30° downward and forward vector relative to the occlusal plane.

DEVICE

Mini Maxillary Protractor (MMP)

An intraoral mini maxillary protraction appliance was used to advance the maxilla. Force was applied through intraoral elastics connected to intraoral anchorage units. The protocol was designed to deliver orthopedic forward traction of the maxilla without an external face mask.

DEVICE

Modified Splint with Elastics and Chin Cup (Modified SEC III)

A modified splint appliance combined with intraoral elastics and an orthopedic chin cup was used to achieve skeletal mandibular retrusion and Class III correction. The appliance applied orthopedic forces through combined vertical and horizontal components, promoting backward positioning of the mandible while maintaining transverse maxillary relationships.

Sponsors & Collaborators

  • TC Erciyes University

    lead OTHER

Principal Investigators

  • Gökhan Çoban, Associate Professor, PhD, · Erciyes University, Faculty of Dentistry, Department of Orhodontics

  • Tuba Ünlü Çiftçi, Research Assistant · Erciyes University, Faculty of Dentistry, Department of Orhodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2025-01-09
Completion
2025-03-03

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 NCT07179354 on ClinicalTrials.gov