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 range7 Years – 12 Years

SexALL

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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.

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