CLASS II DIVISION 1 MALOCCLUSIONAlAzharUNCT07676695
Twin-Block and LIPUS for TMJ Outcomes in Skeletal Class II Patients
A study testing ultrasound in people with CLASS II DIVISION 1 MALOCCLUSION, run by Al-Azhar University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 14 months
- Conditions the study is for
- CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hatem Re Abdelhamid contact
Egypt1 site, 1 recruiting
- Recruiting
Alazhar University in cairo
Cairo, 19777
Mohamed Ha Hablas, Master
About this study
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
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
Read the 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.
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Being tested
- ultrasound
- Keywords
- Class II div 1, Twin Block, CBCT, LIPUS
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
low intensity pulsed ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group only receives functional treatment with twinblock without ultrasound |
| Lipus | Experimental | This group receives low intensity pulsed ultrasound inconjunction with functional treatment using twinblock Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear measurements of condylar head
Condylar head length (mm).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start18 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLASS II DIVISION 1 MALOCCLUSIONStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hatem Refat Hablas, Al-Azhar University
- Investigators
- Khaled Fa Abdallah, Study director, Alazhar university in cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676695
- Sponsor's protocol ID
- AlAzharUU
- Acronym
- AlAzharU
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07676695
- Acronym / sponsor ID
- AlAzharU / AlAzharUU
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Keywords
- Class II div 1, Twin Block, CBCT, LIPUS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group only receives functional treatment with twinblock without ultrasound |
| Lipus | Experimental | Device: ultrasoundThis group receives low intensity pulsed ultrasound inconjunction with functional treatment using twinblock |
Who may qualify
- Ages
- 10 to 14 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundlow intensity pulsed ultrasound | Device | Lipus |
Primary outcome
linear measurements of condylar head
Time frame: 9 months
Condylar head length (mm).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatem Re Abdelhamid contact
Khaled Fa Abdallah study director
Alazhar university in cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with CLASS II DIVISION 1 MALOCCLUSION, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ha Hablas (01278988226, Mohamedhablas1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
linear measurements of condylar head (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.