An interventional study of ultrasound in CLASS II DIVISION 1 MALOCCLUSION, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 10 Months to 14 Months. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
Evaluation of the efficacy of early treatment of skeletal class II patients with twin-block in conjunction with low intensity pulsed ultrasound on temporomandibular joint region: a prospective clinical trial
In this study, twelve male and twelve female children with Class II malocclusion and retrognathic mandible were chosen from the outpatient clinics of the Department of Orthodontics at Al-Azhar University-Boys in Cairo. Their ages varied from nine to twelve.
The patients were split into two groups at random: the low intensity pulsed ultrasound group, which had an average age of 10.55 years, received daily direct application for the first ten days following the placing of the Twin Block appliance, then at least three times a week until mandibular advancement was achieved. LIPUS therapy was administered extra orally on the TMJ region bilaterally using a Sonopower DUO machine, India, LHC-2000.on the right and left sides at the TMJ. Sonication was accomplished by gently massaging the area of interest with 1.5 MHz frequency pulses with a 200-microsecond pulse width, for 20 minutes throughout each session, sonication was repeated at an average intensity of 30 mW/cm2. The control group, which received treatment with a twin block appliance without LIPUS, had an average age of 10.64 years. As part of the authorized orthodontic treatment plan for every patient in the research, the twin block was employed for nine months in both groups.
Prior to and during the Twin Block treatment phase, all patients had CBCT. in addition to the standard orthodontic records. Dentoskeletal measures and TMJ parameters were gathered, recorded, and statistically evaluated to compare changes in the variables within each group and between the two groups.
Version 23 of the SPSS software was used for statistical analysis. A significance criterion of p \< 0.05 was established.
124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.
This study's planned enrollment of 24 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.
Browse Malocclusion, Angle Class II studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
This group only receives functional treatment with twinblock without ultrasound
This group receives low intensity pulsed ultrasound inconjunction with functional treatment using twinblock
Device: ultrasound
low intensity pulsed ultrasound
linear measurements of condylar head
Condylar head length (mm).
Time frame: 9 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
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 planned 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.
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Malocclusion, Angle Class II →