The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Baghdad
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Dentoskeletal and soft tissue changes
Study Overview
Brief Summary
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
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Skeletal and dental relationships: skeletal class III with retrognathic maxilla and normal mandible with overjet < 0 mm.
- •Concave profile with normal lower facial height (clinically and radiographically).
- •Good oral health free from caries and periodontal problems at the start of treatment.
Exclusion Criteria
- •Previous history of orthopedic and/or orthodontic treatment.
- •Patients with vertical growth pattern or backward mandibular rotation tendency.
- •Patients with gross facial asymmetry.
- •Patients with cleft lip and palate and/or craniofacial syndrome
- •Patients with bad oral habit.
- •Active periodontal disease.
- •Previous history of TMJ signs or symptoms
Arms & Interventions
Group 1 (Conventional facemask)
Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion.
Intervention: Conventional facemask appliance (Device)
Group 2 (Modified 3D printed facemask)
Modified facemask appliances will be used for growing patients who have Cl. III malocclusion.
Intervention: Modified 3D printed facemask (Device)
Outcomes
Primary Outcomes
Dentoskeletal and soft tissue changes
Time Frame: (T0) before starting the treatment and (T1) after 9 months of treatments.
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.
Secondary Outcomes
- Skeletal and soft tissue changes((T0) before starting the treatment and (T1) after 9 months of treatments.)
- Dental changes((T0) before starting any treatment and (T1) after 9 months of treatments)
Investigators
Mushriq F. Abid
Professor
University of Baghdad