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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Conventional facemask) | Active Comparator | Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion. |
|
| Group 2 (Modified 3D printed facemask) | Experimental | Modified facemask appliances will be used for growing patients who have Cl. III malocclusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified 3D printed facemask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | (T0) before starting the treatment and (T1) after 9 months of treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | (T0) before starting the treatment and (T1) after 9 months of treatments. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry-University of Baghdad | Recruiting | Baghdad | Al-Rusafa | 01110 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41121454 | Derived | Abdulkareem GB, Cobourne MT, Abid M. The effectiveness of novel 3D printed customized facemask appliance for treatment of class III malocclusion: a randomized clinical trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf075. doi: 10.1093/ejo/cjaf075. |
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| ID | Term |
|---|---|
| D008313 | Malocclusion, Angle Class III |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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
|
| Conventional facemask appliance | Device | 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. |
|
| 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. |
| (T0) before starting any treatment and (T1) after 9 months of treatments |
| Mushriq Abid | Recruiting | Baghdad | 01110 | Iraq |
|