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
Studienübersicht
Status
Intervention / Behandlung
- Verfahren: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
- Verfahren: Arthrocentesis followed by hyaluronic acid injection
- Verfahren: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture
- Verfahren: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Nada Hamed
- Telefonnummer: 00201119659235
- E-Mail: hamednada99@mans.edu.eg
Studienorte
-
-
-
Al Mansurah, Ägypten
- Rekrutierung
- Faculty of Dentistry Mansoura University
-
Kontakt:
- Faculty of Dentistry Mansoura University
- Telefonnummer: 0020502267151
- E-Mail: dentfac@mans.edu.eg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Group I: Arthrocentesis only
|
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
|
|
Aktiver 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
|
|
Aktiver 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
|
|
Aktiver 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Intensity of pain
Zeitfenster: 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
Zeitfenster: preoperative, one week, one month, 3 months and 6 months
|
|
preoperative, one week, one month, 3 months and 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clicking
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Nada Hamed, Faculty of Dentistry Mansoura University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- MS.25.12.93
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .