An interventional study of Modified 3D printed facemask and Conventional facemask appliance in Jaw Protrusions, sponsored by University of Baghdad. Recruiting at 2 sites in Iraq. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's planned enrollment of 34 is close to the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Conventional facemask appliance will be used for growing patients who have Cl. III malocclusion.
Device: Conventional facemask appliance
Modified facemask appliances will be used for growing patients who have Cl. III malocclusion.
Device: Modified 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.
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.
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.
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
Plan to share: Undecided
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Malocclusion, Angle Class III →