- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07270653
Assesment of Tempromandibular Joint ( TMJ ) Changes After Treatment of Skeletal Class II Cases by Twinblock vs Monoblock Appliances
November 26, 2025 updated by: Fatema Mohamad, Faculty of Dental Medicine for Girls
Assessment of Tempromandibular Joint Changes After Treatment of Skeletal Class II Growing Patients by Twin Block Versus Monoblock
Assesment of TMJ changes after treatment of skeletal classII growing patients by Twinblock vs Mono block applinces
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Group (A): patients were treated by Twin block appliance Group (B): patients were treated by Mono block appliance
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Facility of dentistry, Alazhar university, girls branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- skeletal class II malocclusion
- Defecient mandible
- ANB >4
- Growing female patients
- Age from 9-12 years
Exclusion Criteria:
- TMJ disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment of skeletal class II by mandibular advancement using Twin block appliance
Twinblock group
|
Treatment of Skeletal class II by mandibular advancement using twinblock appliances ( removable myofunctional appliance)
|
|
Experimental: treatment of skeletal class II by mandibular advancement using Mono block appliance
Monoblock group
|
Treatment of Skeletal class II by mandibular advancement using Mono block appliances ( removable myofunctional appliance)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Tempromandibular changes including, condylar volume ( in cubic millimeters), length ( in millimeters) , height ( in millimeters) and position( in millimeters)
Time Frame: 8-12 months
|
full skull CBCT
|
8-12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2023
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
November 11, 2025
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
November 26, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
December 8, 2025
Last Update Submitted That Met QC Criteria
November 26, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- ORTO-108-2-G
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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