Hyaluronic Acid and I-PRF Mixture for TMJ Disc Displacement Management
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution, Arthrocentesis followed by hyaluronic acid injection, Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture, Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture.
- Who it may be relevant to
- Registry conditions: TMJ Disc Displacement With Reduction. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Hyaluronic Acid and I-PRF Mixture for Intra-articular Injection Following Arthrocentesis in The Management of TMJ Reducible Disc Displacement: A Four Arm Comparative Trial
Overview
The aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement.
Detailed description
The purpose of this four-arm comparative clinical trial is to evaluate the efficacy of a combined intra-articular injection of Hyaluronic Acid (HA) and Injectable Platelet-Rich Fibrin (i-PRF) following arthrocentesi in patients suffering from temporomandibular joint (TMJ) reducible disc displacement.
All eligible participants will undergo standard TMJ arthrocentesis using Ringer's lactate solution to flush out inflammatory mediators and disrupt intra-articular adhesions.
Patients will be randomly assigned to one of four treatment protocols to compare therapeutic outcomes:
Group I: Arthrocentesis alone (Control). Group II: Arthrocentesis followed by intra-articular injection of Hyaluronic Acid only.
Group III: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and Betamethasone mixture.
Group IV: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and I-PRF mixture (Experimental).
Clinical outcomes include changes in maximum pain-free mouth opening, lateral/protrusive jaw movements, subjective pain intensity scores and presence or absence of clicking Clinical outcomes will be monitored and evaluated over a 6-month post-operative follow-up period to assess which intervention provides the most effective relief and functional restoration.
Interventions
- Procedure 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution - Procedure Arthrocentesis followed by hyaluronic acid injection
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid - Procedure Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture - Procedure Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture
Primary outcome measures
- Intensity of pain [Time frame: preoperative, one week, one month, 3 months and 6 months]
- Maximum interincisal opening, lateral and protrusive movements [Time frame: preoperative, one week, one month, 3 months and 6 months]
Secondary outcome measures (1)
- Clicking [Time frame: preoperative, one week, one month, 3 months and 6 months]
Eligibility criteria
Inclusion criteria
- Age: 18 - 45 years.
- Patients with disc displacement with reduction in any of the TMJs.
- arthralgia.
- Limited unassisted mouth opening.
- Co-operative patients.
Exclusion criteria
- Patients with previous history of TMJ minimally invasive interventions.
- Patients with autoimmune or connective tissue diseases affecting the joints.
- Patients with neurological disorders.
- Patients with a history of condylar fractures or ankylosis.
- Patients with psychological problems.
- Patients receiving non-steroidal anti-inflammatory drugs within 48 hours preoperatively, or systemic use of corticosteroids within 2 weeks.
- Patients on anticoagulants, suffering from platelet function disorders or fibrinogen deficiency.
- Patients with moderate to severe myogenic pain.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry Mansoura University — Al Mansurah
Identifiers
NCT: NCT07683650 · MS.25.12.93