An interventional study of Combined RME and Facemask Therapy and Facemask Therapy Alone in Skeletal Class III Malocclusion, sponsored by Wuhan Integrated Traditional Chinese and Western Medicine Hospital. Completed at 1 site in China. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Wuhan Integrated Traditional Chinese and Western Medicine Hospital · Not applicable, Interventional, and Treatment
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.
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's enrollment of 358 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Wuhan Integrated Traditional Chinese and Western Medicine Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Patients received a tooth-borne Hyrax-type rapid maxillary expander. After the active expansion phase, a Petit-type facemask was delivered, applying a forward and downward protraction force of 400-500g per side for 12-14 hours per day.
Device: Combined RME and Facemask Therapy
Patients received the same facemask protraction therapy as the experimental group (same force, direction, and duration) but without undergoing RME. A removable mandibular occlusal splint was provided to disarticulate the occlusion.
Device: Facemask Therapy Alone
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.
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.
Change in Vertical Linear Cephalometric Measurements
Measured from standardized lateral cephalograms and Cone-Beam Computed Tomography (CBCT) scans. Key measurements include overbite (mm), maxillary molar vertical position (PP-Ms distance, mm), and maxillary anterior position (X-A distance, mm).
Time frame: Baseline, 12 Months
Change in Angular Cephalometric Measurements
Measured from standardized lateral cephalograms and CBCT scans. Key measurements include sagittal jaw relationship (ANB angle, degrees), mandibular plane angle (SN-MP, degrees), and palatal plane angle (SN-PP, degrees).
Time frame: Baseline, 12 Months
Change in Dental Positional Measurements
Change in cephalometric measurements assessing the position and inclination of the incisors, including the UI-NA angle, UI-LI angle (upper to lower incisor angle), UI-NA distance (upper incisor protrusion), and LI-NB distance (lower incisor position). These are measured in degrees or millimeters as appropriate.
Time frame: Baseline (T0) and 6-month follow-up (T1).
Change in Dental Cephalometric Measurements
Measured from lateral cephalograms to assess changes in the inclination of the maxillary and mandibular incisors.
Time frame: Baseline, 12 Months
Ran from Jan 2019 to primary completion in Dec 2023, 59 months.
Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 59 months is above that.
Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Wuhan Integrated Traditional Chinese and Western Medicine Hospital