The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-08-01

Brief Summary

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A randomized clinical trial to introduce a modified 3D printed customized maxillary protraction facemask and evaluate its efficacy in comparison with the conventional maxillary protraction facemask therapy in correction of Class III malocclusion of young patients

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Detailed Description

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It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: conventional facemask appliance will be used while group two, the modified facemask appliances. Lateral cephalometric x-ray, Study models, photographs, and patient questionnaire will be taken before starting the treatment (T0) and at the end of treatment (T1). The effectiveness of the two appliances will be assessed and measured comparing patient's records before and after treatment.

Conditions

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Jaw Protrusions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinding to treatment allocation is possible only for the outcomes assessor because the clinicians know the intervention. The trial documents will be labeled with ID number, which be used for participant identification and data collection without unmasking the allocation group

Study Groups

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Group 1 (Conventional facemask)

Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion.

Group Type ACTIVE_COMPARATOR

Conventional facemask appliance

Intervention Type DEVICE

Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months.

Group 2 (Modified 3D printed facemask)

Modified facemask appliances will be used for growing patients who have Cl. III malocclusion.

Group Type EXPERIMENTAL

Modified 3D printed facemask

Intervention Type DEVICE

modified 3D printed customized maxillary protraction facemask will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months.

Interventions

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Modified 3D printed facemask

modified 3D printed customized maxillary protraction facemask will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months.

Intervention Type DEVICE

Conventional facemask appliance

Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion, hyrax expansion appliance and applying an elastic force of 300-500 gram per side for 12-14 hours per day. Treatment time 9 months.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet \< 0 mm.
2. Concave profile with normal lower facial height (clinically and radiographically).
3. Good oral health free from caries and periodontal problems at the start of treatment.

Exclusion Criteria

1. Previous history of orthopedic and/or orthodontic treatment.
2. Patients with vertical growth pattern or backward mandibular rotation tendency.
3. Patients with gross facial asymmetry.
4. Patients with cleft lip and palate and/or craniofacial syndrome
5. Patients with bad oral habit.
6. Active periodontal disease.
7. Previous history of TMJ signs or symptoms

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes