Effectiveness of a 3D printed facemask for treating jaw protrusions
The Effectiveness of Modified 3D Printed Customized Facemask Appliance for Treatment of Class III Malocclusion: A Randomized Clinical Trial
This study is testing if a new 3D printed facemask works better than a regular facemask to help young patients with jaw protrusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 2 sites (Baghdad, Al-Rusafa and 1 other locations) |
| Trial ID | NCT06250127 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a modified 3D printed customized maxillary protraction facemask compared to a conventional facemask in treating Class III malocclusion in young patients. It is a multicenter randomized trial where participants are divided into two groups, one receiving the modified facemask and the other the conventional appliance. The study will assess treatment outcomes using lateral cephalometric x-rays, study models, photographs, and patient questionnaires before and after treatment. The goal is to determine which appliance provides better correction of jaw protrusions.
Who should consider this trial
Good fit: Ideal candidates are young patients with skeletal Class III malocclusion characterized by a retrognathic maxilla and normal mandible.
Not a fit: Patients with previous orthodontic treatment, significant facial asymmetry, or certain dental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for young patients with Class III malocclusion.
How similar studies have performed: While the use of facemasks in orthodontics is established, the specific application of a modified 3D printed facemask is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baghdad, Al-Rusafa and 1 other locations
- College of Dentistry-University of Baghdad — Baghdad, Al-Rusafa, Iraq (Recruiting)
- Mushriq Abid — Baghdad, Iraq (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.