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
Studieoversigt
Status
Betingelser
Intervention / Behandling
- 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
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Nada Hamed
- Telefonnummer: 00201119659235
- E-mail: hamednada99@mans.edu.eg
Studiesteder
-
-
-
Al Mansurah, Egypten
- Rekruttering
- Faculty of Dentistry Mansoura University
-
Kontakt:
- Faculty of Dentistry Mansoura University
- Telefonnummer: 0020502267151
- E-mail: dentfac@mans.edu.eg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensity of pain
Tidsramme: 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
Tidsramme: preoperative, one week, one month, 3 months and 6 months
|
|
preoperative, one week, one month, 3 months and 6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clicking
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nada Hamed, Faculty of Dentistry Mansoura University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MS.25.12.93
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .