TMJ Disc Displacement With Reduction
Conditions
Keywords
TMJ, Disc Displacement With Reduction, Arthrocentesis, Hyaluronic Acid, I-PRF
Brief summary
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
PROCEDURE18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
PROCEDUREArthrocentesis 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
PROCEDUREArthrocentesis 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
PROCEDUREArthrocentesis 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 - 45 years. 2. Patients with disc displacement with reduction in any of the TMJs. 3. arthralgia. 4. Limited unassisted mouth opening. 5. Co-operative patients.
Exclusion criteria
1. Patients with previous history of TMJ minimally invasive interventions. 2. Patients with autoimmune or connective tissue diseases affecting the joints. 3. Patients with neurological disorders. 4. Patients with a history of condylar fractures or ankylosis. 5. Patients with psychological problems. 6. Patients receiving non-steroidal anti-inflammatory drugs within 48 hours preoperatively, or systemic use of corticosteroids within 2 weeks. 7. Patients on anticoagulants, suffering from platelet function disorders or fibrinogen deficiency. 8. Patients with moderate to severe myogenic pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | preoperative, one week, one month, 3 months and 6 months | 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 |
| Maximum interincisal opening, lateral and protrusive movements | preoperative, one week, one month, 3 months and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clicking | preoperative, one week, one month, 3 months and 6 months | clicking will be evaluated as either present or absent throughout the follow up intervals |
Countries
Egypt
Contacts
CONTACTNada Hamed
PRINCIPAL_INVESTIGATORNada Hamed
Faculty of Dentistry Mansoura University
Outcome results
None listed