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

University of Baghdad

Status: Enrolling

Conditions: Jaw Protrusions

Treatments: Device: Conventional facemask appliance; Device: Modified 3D printed facemask

Study type: Interventional

Funder types: Other

Identifiers

NCT06250127

882423

Details and patient eligibility

About

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

Full description

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Group 1 (Conventional facemask)

Active Comparator group

Description:

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

Treatment:

Device: Conventional facemask appliance

Group 2 (Modified 3D printed facemask)

Experimental group

Description:

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

Treatment:

Device: Modified 3D printed facemask