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

University of Baghdad34 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Jaw Protrusions

Interventions

Modified 3D printed facemaskDEVICE

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.

Conventional facemask applianceDEVICE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

College of Dentistry-University of Baghdad

Baghdad, Al-Rusafa, Iraq

RECRUITING

Mushriq Abid

Baghdad, Iraq

RECRUITING

Outcomes

Primary Outcomes

Dentoskeletal and soft tissue changes

Cephalometric analysis will be perfomed by measured different skeletal and soft tissue points in degrees at two time (T) intervals, (T0) before starting the treatment and (T1) at 9 months after treatment.

Time frame: (T0) before starting the treatment and (T1) after 9 months of treatments.

Secondary Outcomes

Skeletal and soft tissue changes

Skeletal changes by comparing the changes of SNA, SNB and ANB angles in degrees using cephalometric x-rays at two time intervals, (T0) before starting the treatment and (T1) after 9 months of treatments.

Time frame: (T0) before starting the treatment and (T1) after 9 months of treatments.

Dental changes

Dental changes will be evalauted by comparing over jet changes in millimeters assessed using study models.at two time intervals, (T0) before starting the treatment and (T1) after 9 months of treatments.

Time frame: (T0) before starting any treatment and (T1) after 9 months of treatments

Data from ClinicalTrials.gov

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