Twin Block and Low-Intensity Pulsed Ultrasound for Class II Division 1 Malocclusion in Kids
Official title: 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
Run by Al-Azhar University · NCT07676695 · Data updated 2026-11-12
This study tests whether adding low-intensity pulsed ultrasound to a twin-block appliance helps improve jaw alignment in children with Class II Division 1 malocclusion.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Months to 14 Months |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | June 18, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07676695 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 9–12 with skeletal Class II due to retrognathic mandible, no prior orthodontic treatment, and requiring mandibular advancement with a Twin Block appliance.
✕Probably not a fit
Patients with TMJ disorders, prognathic maxilla, poor oral hygiene, or previous orthodontic treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective clinical trial, 24 children aged 9–12 with skeletal Class II due to a retrognathic mandible were randomized to receive a Twin Block appliance alone or with daily low-intensity pulsed ultrasound (LIPUS) therapy. LIPUS was applied bilaterally to the temporomandibular joint region during the initial 10 days and then at least three times per week until mandibular advancement was achieved, across a nine-month treatment period. CBCT and standard orthodontic records were collected to measure dentoskeletal and TMJ parameters before and during treatment. The trial aims to determine if adding LIPUS enhances treatment-related changes compared with Twin Block alone.
Why it matters
Potential benefit: If successful, LIPUS could enhance skeletal and TMJ outcomes during early correction of Class II malocclusion.
How similar studies have gone: Prior studies in similar populations have explored adjunctive therapies with orthodontic appliances, but this exact combination (Twin Block plus LIPUS for TMJ-targeted outcomes) is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Skeletal class II due to retrognathic mandible. * Angle's class II Molar relationship. * All patients involved in the study were in stages II and III based on the modified cervical vertebral maturation stages (CVMS) by Bacetti et al.5 * Proclined upper incisors * Increased overjet \> 5 mm. * Aligned lower arch or average inclination * Minimal crowding of lower arch. * No history of previous orthodontic treatment. Exclusion Criteria: * Skeletal class II due to prognathic maxilla. * Patient with gross facial asymmetry. * Previous orthodontic or orthopedic treatment. * Clinical signs and symptoms of any Temporomandibular joint disorders. * Increased anterior facial vertical dimension. * Poor oral hygiene.
Where it's running
-
Alazhar University in cairo
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed Ha Hablas
- Email: Mohamedhablas1995@gmail.com
- Phone: 01278988226
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Clear twin block for growing patients with class II malocclusion
This study tests whether wearing a clear twin block appliance for 3 months helps correct dento-skeletal differences in kids aged 9–12 with Class II Division 1 malocclusion.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.