Clinical trial Recruiting at 1 site Interventional Ages 10 Months to 14 Months

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.

More CLASS II DIVISION 1 MALOCCLUSION trials

Quick facts

Study typeInterventional
Ages10 Months to 14 Months
SexAll
Enrollment24 (estimated)
SponsorAl-Azhar University
Academic / other
Locations1 site (Cairo)
StatusRecruiting
StartedJune 18, 2026
Main results expectedJune 30, 2027
Study endsJune 30, 2027
Registry record updatedJune 30, 2026
Trial IDNCT07676695 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.