An interventional study of 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution and Arthrocentesis followed by hyaluronic acid injection in TMJ Disc Displacement With Reduction, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
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.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
Procedure: Arthrocentesis followed by hyaluronic acid injection
Procedure: Arthrocentesis followed by 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
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular 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 I-PRF mixture
Intensity of pain
Pain intensity will be evaluated subjectively using Numeric Rating Scale from zero to 10 zero indicates no pain at all 10 indicates the worst pain ever
Time frame: preoperative, one week, one month, 3 months and 6 months
Maximum interincisal opening, lateral and protrusive movements
1. Maximum interincisal opening: the distance in millimeters between the incisal edges of the central incisors in vertical direction at maximum pain free mouth opening, measured using a caliper. 2. Range of lateral and protrusive movements: the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements, measured using a caliper.
Time frame: preoperative, one week, one month, 3 months and 6 months
Clicking
clicking will be evaluated as either present or absent throughout the follow up intervals
Time frame: preoperative, one week, one month, 3 months and 6 months
Plan to share: No
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Mansoura University