Treating Growing Patients With Mandibular Prognathism and Maxillary Constriction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized controlled trial intends to test the efficacy of two treatment protocols in the correction of Class III malocclusion with maxillary constriction. We have to options, either to modify the growth using inter-maxillary traction based on an upper fixed appliance that is used in the same time for rapid maxillary expansion or to inhibit mandibular growth by a removable mandibular retractor (RMR) supplied with an expansion screw.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Pain and Functional Impairments When Treating Class III Malocclusion Using Two Treatment Procedures

NCT06877780

Class III Malocclusion Maxillary Deficiency

COMPLETED NA

Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects

NCT03159962

Malocclusion, Angle Class II Malocclusion

COMPLETED NA

Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances

NCT02144324

Class III Malocclusion in Growing Patients

COMPLETED NA

Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

NCT03172442

Class III Malocclusion

COMPLETED NA

Comparative 3D Assessment of Class III Malocclusion Treatments

NCT07179354

Class III Skeletal Malocclusion

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Class III Malocclusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RMR with SME

The removable mandibular retractor (RMR) will inhibit mandibular growth. This appliance will be supplemented with a medline screw that is used for slow maxillary expansion (SME).

Group Type EXPERIMENTAL

RMR+SME

Intervention Type DEVICE

Patients will be asked to wear this removable appliance for 16 hours daily. The expansion screw is activated twice a week.

BAIMT with RME

Bone-anchored intermaxillary traction (BAIMT) will be used for Class III correction.

This upper part of the appliance is used for rapid maxillary expansion (RME).

Group Type ACTIVE_COMPARATOR

BAIMT+RME

Intervention Type DEVICE

The elastics are worn 18 hours per day to achieve the sagittal correction. The RME appliance on the upper jaw is activated twice daily until the required expansion is achieved.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RMR+SME

Patients will be asked to wear this removable appliance for 16 hours daily. The expansion screw is activated twice a week.

Intervention Type DEVICE

BAIMT+RME

The elastics are worn 18 hours per day to achieve the sagittal correction. The RME appliance on the upper jaw is activated twice daily until the required expansion is achieved.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. growing male and female patients aged between 12 and 15 years
2. Angle's class III malocclusion
3. skeletal class III relationship judged clinically and confirmed radiographically (-4 \< ANB \< + 1)
4. An anterior crossbite involving two or more teeth or an edge-to-edge incisor relationship with or without an anterior shift of the lower jaw upon closure
5. normal inclination of the lower incisors or slightly proclined (i.e., the IMPA between 85° and 100°
6. maxillary constriction requiring expansion judged clinically and confirmed radiographically
7. permanent dentition
8. no previous orthodontic treatment

Exclusion Criteria

1. skeletal class III malocclusion caused predominantly by maxillary deficiency (SNA\<78° with a normal SNB angle)
2. severe skeletal class III presenting mainly due to mandibular protrusion (ANB \< - 4° with no functional shift on closure)
3. contraindications for the use of the mini-screws, such as osteoporosis (addressed with cortisone and its derivatives) or those undergoing radiation treatment
4. a convergence between the mandibular canine root and the first premolar root ,which was assessed radiographically
5. facial asymmetry, characterized by a mandibular midline deviation exceeding 2 mm from the facial midline
6. MM angle \>35° or SN-MP angle \> 40°
7. The existence of cleft lip or craniofacial syndromes and/or palate abnormalities and
8. The existence of supernumerary teeth or missing ones except for the third molars.

Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No