- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07643402
Clinical and Jaw Tracking Assessment Following Intra-articular Injection of PRP and HA in TMJ Disc Displacement With Reduction
September 2, 2026 updated by: Eslam Elbatal, Mansoura University
Biomechanical Assessment of Platelet Rich Plasma and Hyaluronic Acid Intra-articular Injection in Temporomandibular Joint Internal Derangement Using a Jaw Tracking Device
Assessment of intra-articular injection of hyaluronic acid and prp within TMJ using the Zebris jaw tracking device as an objective method
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35516
- Faculty of Dentistry, Mansoura University
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- The patients' ages range from 18 to 45.
- Patients experienced clicking sounds, painful joints, and restricted mouth opening.
- Individuals whose MRI confirms a unilateral internal abnormality with reduction.
- A patient who did not respond to conservative treatment. 5 • The patient's capacity and willingness to finish the course of therapy and subsequent appointments.
Exclusion Criteria
- A patient suffering from a connective tissue or inflammatory condition.
- A patient who has had TMJ surgery in the past.
- A history of injecting any kind of material into the target TMJ.
- Drug allergy history.
- A patient who has previously had fibrous or bony adhesion.
- A patient experiencing psychological issues.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hyaluronic acid + PRP
patients with disc displacement with reduction will undergo intra-articular injection with hyaluronic acid and prp
|
A combination of Autologous Platelet-Rich Plasma prepared from the patient's blood and hyaluronic acid injected intra-articularly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mandibular movements assessed using the zebris JMA
Time Frame: Baseline, 1month
|
changes in mandibular movements assessed using the Zebris Jaw Motion Analyzer (JMA) system following treatment
|
Baseline, 1month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clicking sound
Time Frame: Baseline, 6 months
|
changes in clicking sound following treatment
|
Baseline, 6 months
|
|
Pain Assessment using the Visual Analogue Scale
Time Frame: baseline, 1 week, 1 month, 3months, 6 months
|
Changes in pain intensity assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate greater pain severity.
Measurements will be obtained at baseline, 1 week, 1 month, 3 months, and 6 months following intra-articular injection of hyaluronic acid and platelet-rich plasma (PRP) in patients with temporomandibular joint disc displacement with reduction.
|
baseline, 1 week, 1 month, 3months, 6 months
|
|
MRI assessment of the temporomandibular joint
Time Frame: At baseline and 6 months after treatment
|
MRI assessment of the temporomandibular joint, including disc position and retrodiscal tissue changes,
|
At baseline and 6 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2025
Primary Completion (Actual)
November 15, 2025
Study Completion (Actual)
May 5, 2026
Study Registration Dates
First Submitted
June 7, 2026
First Submitted That Met QC Criteria
June 7, 2026
First Posted (Actual)
June 11, 2026
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Muscular Diseases
- Joint Diseases
- Jaw Diseases
- Infections
- Neurodegenerative Diseases
- Sleep Wake Disorders
- Mandibular Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Central Nervous System Infections
- Craniomandibular Disorders
- Prion Diseases
- Sleep Initiation and Maintenance Disorders
- Temporomandibular Joint Disorders
- Insomnia, Fatal Familial
- Carbohydrates
- Glycosaminoglycans
- Polysaccharides
- Hyaluronic Acid
Other Study ID Numbers
- MS.25.03.12
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.