Evaluation of Arthrocentesis With and Without PRP Injection in Patients With Disc Displacement With Reduction.

NCT05983653 | Completed

• 1 other identifier: arthrocentesis and PRP on TMJ
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aiming To evaluate the treatment effect (anti-inflammatory and healing ) of PRP with arthrocentesis versus arthrocentesis alone on the management of anterior disc displacement with reduction

Conditions

TMJ Disc Disorder

Keywords

anterior disc displacment with reduction

Outcome Measures

Primary Outcomes (1)

• TMJ pain

  pain will be measured by Numerical rating scale from 0-10 (0 the lowest pain , 10 the greatest pain) ,will be measured before intervention , immediately after intervention and on follow up ( 1 week , 1 month , 3 month and 6 month after intervention )

  first day , after 1 week , after 1 month, 3 month and after 6 months of procedure

Secondary Outcomes (2)

• maximum mouth opening

  first day , after 1 week , after 1 month, 3 month and after 6 months of procedure

• Disc position on TMJ

  before procedure and after 6 months of procedure

Study Arms (2)

150 ml of normal saline lavage

ACTIVE COMPARATOR

in the first arm, 150 ml of normal saline lavage alone without PRP

Procedure: arthrocentesis without PRP

150 ml arthrocentesis with PRP

ACTIVE COMPARATOR

in the second arm, 150 ml of normal saline arthrocentesis with PRP

Procedure: arthrocentesis with PRP

Interventions

arthrocentesis without PRP PROCEDURE

150 ml arthrocentesis without PRP

150 ml of normal saline lavage

arthrocentesis with PRP PROCEDURE

150 ml arthrocentesis with PRP

150 ml arthrocentesis with PRP

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients were excluded from the study if they had previous TMJ surgery, a medical history of any systematic disease, and patients participating in other studies.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo Universty

Cairo, Manial, 11511, Egypt

Location

Related Publications (1)

• Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.

  PMID: 36523721 BACKGROUND

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yasmine AA Nassar

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator ,master degree candidiate

Model Details: After medical and dental history then clinical examination. A preoperative panoramic radiograph was taken as a primary survey to exclude the presence of any lesion at the area of interest and an MRI to evaluate disc position infiltration of plain anesthesia was administered to anesthetizing the auriculotemporal, posterior deep temporal, and masseter nerves. Scrubbing and draping of the patient was carried out by using betadine. Drawn canthotragal line. two needle insertion points are marked. The first will be at a distance of 10 mm from the tragus and 2 mm below the cantotragal line. The second point will be 20 mm in front of the tragus and 10 mm below this line. Two 19 gauge needles are inserted in these 2 points(upper joint space) Normal saline 200 ml is injected into the superior joint space. The second needle acts as an outflow portal * in the 1 st study group: The lavage will be 150 ml of normal saline * in the 2 nd study group: The lavage will be 150 ml of normal saline +PRP

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

EG (1)