Hyaluronic Acid and I-PRF Mixture for TMJ Disc Displacement Management
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
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Procedur: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
- Procedur: Arthrocentesis followed by hyaluronic acid injection
- Procedur: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture
- Procedur: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Nada Hamed
- Telefonnummer: 00201119659235
- E-post: hamednada99@mans.edu.eg
Studieorter
-
-
-
Al Mansurah, Egypten
- Rekrytering
- Faculty of Dentistry Mansoura University
-
Kontakt:
- Faculty of Dentistry Mansoura University
- Telefonnummer: 0020502267151
- E-post: dentfac@mans.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group I: Arthrocentesis only
|
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
|
|
Aktiv komparator: Group II: 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
|
|
Aktiv komparator: Group III: 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
|
|
Aktiv komparator: Group IV: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intensity of pain
Tidsram: 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
|
preoperative, one week, one month, 3 months and 6 months
|
|
Maximum interincisal opening, lateral and protrusive movements
Tidsram: preoperative, one week, one month, 3 months and 6 months
|
|
preoperative, one week, one month, 3 months and 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clicking
Tidsram: preoperative, one week, one month, 3 months and 6 months
|
clicking will be evaluated as either present or absent throughout the follow up intervals
|
preoperative, one week, one month, 3 months and 6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nada Hamed, Faculty of Dentistry Mansoura University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- MS.25.12.93
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