Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
AlAzharU
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
1 other identifier
interventional
24
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedStudy Start
First participant enrolled
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 30, 2026
June 1, 2026
1 year
June 16, 2026
June 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
linear measurements of condylar head
Condylar head length (mm).
9 months
Study Arms (2)
Control
NO INTERVENTIONThis group only receives functional treatment with twinblock without ultrasound
Lipus
EXPERIMENTALThis group receives low intensity pulsed ultrasound inconjunction with functional treatment using twinblock
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alazhar University in cairo
Cairo, 19777, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Khaled Fa Abdallah
Alazhar university in cairo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 30, 2026
Study Start
June 18, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share