NCT07053683

Efficacy of RME and Facemask Therapy for Class III Malocclusion

Enhanced Efficacy of Early Orthopedic Intervention With Rapid Maxillary Expansion and Facemask Protraction on Skeletal and Quality of Life Outcomes in Class III Malocclusion: A Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Wuhan Integrated Traditional Chinese and Western Medicine Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This multicenter randomized controlled trial compares the efficacy of Rapid Maxillary Expansion (RME) combined with facemask (FM) protraction versus FM protraction alone in treating growing children with skeletal Class III malocclusion. The study aims to evaluate the differences in vertical skeletal changes and Oral Health-Related Quality of Life (OHRQoL) between the two treatments.

Detailed description

Skeletal Class III malocclusion is a challenging craniofacial anomaly, particularly prevalent in Asian populations. Early orthopedic intervention aims to correct the discrepancy and guide favorable growth. While facemask (FM) protraction is a standard treatment, its efficacy can be enhanced by Rapid Maxillary Expansion (RME), which is thought to disarticulate the circummaxillary sutures and facilitate a better orthopedic response. This prospective, multicenter, randomized controlled trial was designed to rigorously compare the combined RME+FM therapy against FM therapy alone. The study's primary objective was to assess the impact of these interventions on vertical skeletal dimensions, a key concern in Class III treatment. The secondary objective was to evaluate the patient-centered outcome of Oral Health-Related Quality of Life (OHRQoL). Eligible patients aged 7-12 were randomly assigned to one of two treatment groups. Cephalometric and OHRQoL data were collected at baseline and after 12 months of active treatment to determine if the combined approach offers superior clinical outcomes.

Conditions

• Skeletal Class III Malocclusion

Interventions

Type	Name	Description
DEVICE	Combined RME and Facemask Therapy	This intervention involves two components. First, a tooth-borne Hyrax-type rapid maxillary expander is banded to the maxillary first permanent and deciduous molars. The screw is activated twice daily until posterior crossbite is overcorrected. Second, immediately following expansion, a Petit-type facemask is used to apply orthopedic protraction forces to the maxilla.
DEVICE	Facemask Therapy Alone	This intervention involves the use of a Petit-type facemask to apply orthopedic protraction forces (400-500g per side, 12-14 hours/day) to the maxilla. A removable mandibular occlusal splint (flat bite plane) is used concurrently to facilitate anterior crossbite correction.

Timeline

• Start date: 2019-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2025-07-08
• Last updated: 2025-08-22

Locations

1 site across 1 country: China