CompletedNot Applicable

Efficacy of RME and Facemask Therapy for Class III Malocclusion

China358 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Skeletal Class III malocclusion (ANB angle ≤ 0°) with a Wits appraisal ≤ -2 mm. * Maxillary deficiency (SNA angle ≤ 80°). * Prepubertal stage of skeletal development (Cervical Vertebral Maturation Stage CS1-CS3). * Age between 7 and 12 years. * Anterior crossbite or edge-to-edge incisor relationship. * Angle Class III or end-on molar relationship. * No previous orthodontic treatment. Exclusion Criteria: * Functional Class III malocclusion with no centric relation-centric occlusion discrepancy. * Congenital craniofacial anomalies (e.g., cleft lip/palate). * Severe systemic diseases. * History of maxillofacial trauma.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Vertical Linear Cephalometric Measurements

Timeframe: Baseline, 12 Months

Change in Angular Cephalometric Measurements

Timeframe: Baseline, 12 Months

Trial details

NCT IDNCT07053683

SponsorWuhan Integrated Traditional Chinese and Western Medicine Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Skeletal Class III Malocclusion trials