Skeletal Class III MalocclusionNCT07053683
Efficacy of RME and Facemask Therapy for Class III Malocclusion
A study testing Combined RME and Facemask Therapy and Facemask Therapy Alone in people with Skeletal Class III Malocclusion, run by Wuhan Integrated Traditional Chinese and Western Medicine Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Skeletal Class III Malocclusion
- What is being tested?
- Combined RME and Facemask Therapy and Facemask Therapy Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Combined RME and Facemask Therapy, Facemask Therapy Alone
- Keywords
- Palatal Expansion Technique, Extraoral Traction Appliances, Malocclusion, Angle Class III, Cephalometry, Rapid Maxillary Expansion, Oral Health-Related Quality of Life
- Medical subject headings
- Malocclusion, Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined RME and Facemask TherapyDevice
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.
Facemask Therapy AloneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: RME+FM Group | Experimental | 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. Receives: Device: Combined RME and Facemask Therapy |
| Control: Facemask (FM) Alone Group | Active comparator | 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. Receives: Device: Facemask Therapy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline, 12 Months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class III MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lulu Wang, Wuhan Integrated Traditional Chinese and Western Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053683
- Sponsor's protocol ID
- WHH-ORTHO-2018-021
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07053683
- Acronym / sponsor ID
- WHH-ORTHO-2018-021
- Conditions
- Skeletal Class III Malocclusion
- Keywords
- Palatal Expansion Technique, Extraoral Traction Appliances, Malocclusion, Angle Class III, Cephalometry, Rapid Maxillary Expansion, Oral Health-Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Wuhan Integrated Traditional Chinese and Western Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: RME+FM Group | Experimental | Device: Combined RME and Facemask TherapyPatients 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. |
| Control: Facemask (FM) Alone Group | Active comparator | Device: Facemask Therapy AlonePatients 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined RME and Facemask TherapyThis 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 | Experimental: RME+FM Group |
| Facemask Therapy AloneThis 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. | Device | Control: Facemask (FM) Alone Group |
Primary outcome
Change in Vertical Linear Cephalometric Measurements
Time frame: Baseline, 12 Months
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).
Change in Angular Cephalometric Measurements
Time frame: Baseline, 12 Months
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).
2 secondary outcomes
Change in Dental Positional Measurements
Time frame: Baseline (T0) and 6-month follow-up (T1).
Change in Dental Cephalometric Measurements
Time frame: Baseline, 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined RME and Facemask Therapy and Facemask Therapy Alone in people with Skeletal Class III Malocclusion, run by Wuhan Integrated Traditional Chinese and Western Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vertical Linear Cephalometric Measurements (time frame: Baseline, 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.