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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Arthrocentesis only | Active Comparator |
| |
| Group II: Arthrocentesis followed by hyaluronic acid injection | Active Comparator |
| |
| Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture | Active Comparator |
| |
| Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution | Procedure | 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | preoperative, one week, one month, 3 months and 6 months |
| Maximum interincisal opening, lateral and protrusive movements |
| preoperative, one week, one month, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clicking | clicking will be evaluated as either present or absent throughout the follow up intervals | preoperative, one week, one month, 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nada Hamed | Contact | 00201119659235 | hamednada99@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nada Hamed | Faculty of Dentistry Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Mansoura University | Recruiting | Al Mansurah | Egypt |
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| Arthrocentesis followed by hyaluronic acid injection | Procedure | 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid |
|
| Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture | Procedure | 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture |
|
| Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture | Procedure | 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture |
|