An interventional study of Myobrace Functional Appliance and Twin Block in Malocclusion, Angle Class II, Division 1, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 9 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare the pharyngeal airway changes after treatment with Myobrace and after treatment with Twinblock in developing skeletal Class II patients.
The main question it aims to answer is: Is the efficacy of the twin-block Vs Myobrace appliances in the improvement of pharyngeal airway dimensions in adolescents having skeletal Class II malocclusion with retrognathic mandible utilizing sagittal pharyngeal airway area measurements.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's enrollment of 26 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Thirteen patients with developing skeletal Class II malocclusion will be treated with Myobrace functional appliance for six months.
Device: Myobrace Functional Appliance
Thirteen patients with developing skeletal Class II malocclusion will be treated with Twinblock functional appliance for six months.
Device: Twin Block
An Appliance for treating growing Class II patients with mandibular deficiency
An Appliance for treating growing Class II patients with mandibular deficiency
SNA
Angle formed between points Sella, Nasion and A point and describes anteroposterior position of the maxilla relative to the anterior cranial base.
Time frame: Six months
SNB
Angle formed between points Sella, Nasion and B point and describes anteroposterior position of the mandible relative to the anterior cranial base.
Time frame: Six months
ANB
Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.
Time frame: Six months
Witts appraisal
The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.
Time frame: Six months
FMA
Angle formed between mandibular plane and Frankfort horizontal plane.
Time frame: Six months
Pharyngeal air way area measurement
The upper border of Naso Pharyngeal air way area will be delineated by a line extending from the harmonium (H) to the posterior nasal spine. The lower extent of the NPAA will be traced by marking a line at the tip of the soft palate parallel to the Frankfort horizontal (FH) plane extending to the posterior wall of the pharynx. The OPAA and LPAA are differentiated by a line drawn at the level of the tip of epiglottis parallel to the FH plane to the posterior wall of the pharynx. The lower border of the LPAA is defined as a line drawn parallel to FH plane and passing through the anteroinferior most point (C5AI) of the fifth cervical vertebra. Area will be measured.
Time frame: Six months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Apr 2023, 12 months.
Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 12 months is below that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class II →