- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07571265
Intra-articular Injection for the Relief of Temporomandibular Joint Pain
A Comparative Study on the Impact of Intra-articular Injections of Hyaluronic Acid, Platelet-rich Plasma and Triamcinolone Acetonide on the Relief of Temporomandibular Joint Pain
Study Overview
Status
Conditions
Detailed Description
Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.
The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.
The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.
Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.
In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cairo Governorate
-
Al Manyal, Cairo Governorate, Egypt, 11553
- Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
- 2. Age ≥ 18 years < 50
Exclusion Criteria:
- 1. Previous TMJ surgery
- 2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
- 3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
- 4. pregnant women or breastfeeding ones
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: platelet rich plasma(PRP)
|
|
|
Active Comparator: triamcinolone acetonide
|
|
|
Active Comparator: hyaluronic acid
|
|
|
Placebo Comparator: saline(placebo)
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.
|
preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
|
pain-free mouth opening
Time Frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
The maximum mouth opening measured with a caliper in millimeters.
|
preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
crepitus sounds
Time Frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
asking the patient at every appointment
|
preoperative as baseline then after one week, 1 month, 3 months and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed MA el saadany, master, mohamed_mostafa@dentistry.cu.edu.eg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intra articular injections
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Temporomandibular Arthritis
-
LabrhaCompletedTemporomandibular Arthritis | Arthritis of Temporomandibular JointFrance
-
Medical University of ViennaRecruitingArthritis of Temporomandibular JointAustria
-
Wroclaw Medical UniversityEnrolling by invitationTemporomandibular Joint Disorders | Temporomandibular Disorder | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisPoland
-
Josip Juraj Strossmayer University of OsijekUniversity of Rijeka Faculty of Dental MedicineActive, not recruitingRheumatoid Arthritis | Temporomandibular DisordersCroatia
-
Karolinska InstitutetUniversity of Oslo; University of BergenCompletedTemporomandibular Joint Disorders | Temporomandibular Joint Disc Displacement | Temporomandibular Joint Osteoarthritis | Temporomandibular ArthritisSweden
-
Örebro University, SwedenNot yet recruitingOsteoarthritis | Ankylosis | TMJ Disorder
-
Malin CollinKarolinska InstitutetActive, not recruitingJuvenile Idiopathic Arthritis | Temporomandibular ArthritisSweden
-
Dr. Amit DruyanSheba Medical CenterRecruitingTemporomandibular Joint OsteoarthritisIsrael
-
Cairo UniversityNot yet recruitingTemporomandibular Joint Osteoarthritis
Clinical Trials on platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection
-
Assistance Publique Hopitaux De MarseilleNot yet recruiting
-
Tri-Service General HospitalCompletedHemophilia | Hemophilic Arthropathy
-
Cairo UniversityTanta UniversityCompleted
-
South Valley UniversityCompleted
-
Istanbul UniversityCompletedKnee OsteoarthritisTurkey
-
Guangdong Hongzhi Biotechnology Co.Third Affiliated Hospital, Sun Yat-Sen University; Shantou Central Hospital; Nanfang...Enrolling by invitation
-
Mansoura UniversityCompletedTMJ Disc DisorderEgypt
-
Tri-Service General HospitalCompletedKnee OsteoarthritisTaiwan
-
Mahidol UniversityCompletedAdhesive Capsulitis of the ShoulderThailand
-
Universidade do PortoUnidade Local de Saude Gaia EspinhoNot yet recruitingKnee OsteoarthritisPortugal