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

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

Study Overview

• Status: Recruiting
• Conditions: CLASS II DIVISION 1 MALOCCLUSION
• Intervention / Treatment: Device: ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ha Hablas; Phone Number: 01278988226; Email: Mohamedhablas1995@gmail.com
• Study Contact Backup: Name: Hatem Re Abdelhamid; Phone Number: 01002706800

Study Locations

• Egypt
  • Cairo, Egypt, 19777
    • Recruiting
    • Alazhar University in cairo
    • Contact: Mohamed Ha Hablas, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This group only receives functional treatment with twinblock without ultrasound
Experimental: Lipus; This group receives low intensity pulsed ultrasound inconjunction with functional treatment using twinblock	Device: ultrasound; low intensity pulsed ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
linear measurements of condylar head	Condylar head length (mm).	9 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Khaled Fa Abdallah, Alazhar University in cairo

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: CBCT; Twin Block; LIPUS; Class II div 1
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: AlAzharUU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No