Jaw Protrusions
Conditions
Keywords
Orthopedic appliance, Maxillary protraction, Petit facemask, Cl III malocclusion
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.
Interventions
DEVICEModified 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.
DEVICEConventional 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.
Sponsors
University of Baghdad
Study design
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
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dentoskeletal and soft tissue changes | (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
| Measure | Time frame | Description |
|---|---|---|
| Skeletal and soft tissue changes | (T0) before starting the treatment and (T1) after 9 months of treatments. | 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. |
| Dental changes | (T0) before starting any treatment and (T1) after 9 months of treatments | 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. |
Countries
Iraq
Outcome results
None listed