Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis

NCT04810923 | Completed

• 1 other identifier: 19-11/47
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; injectable platelet-rich fibrin; Arthrocentesis

Outcome Measures

Primary Outcomes (1)

• Change of Pain Level

  Pain level was measured with a visual analog scale (VAS) before treatment, and at postoperative follow-up (1st, 2nd, 3rd, 6th and 12th month).

  at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month

Secondary Outcomes (3)

• Change of maximum mouth opening

  at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month

• Change of lateral movement

  at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month

• Change of protrusive movement

  at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month

Study Arms (2)

i-PRF group

EXPERIMENTAL

arthrocentesis procedure plus four consecutive intra-articular injection of i-PRF.

Procedure: i-PRF

Control group

EXPERIMENTAL

arthrocentesis procedure alone.

Procedure: Arthrocentesis

Interventions

i-PRF PROCEDURE

intra-articular i-PRF injection after arthrocentesis

i-PRF group

Arthrocentesis PROCEDURE

Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.

Control group

Eligibility Criteria

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

You may qualify if:

• patients with osteoarthritis (OA) of one or two temporomandibular joint (TMJ)
• maximum mouth opening less than 35 mm
• impeded protrusive and lateral movements
• localized pain of the affected joint

You may not qualify if:

• systemic or malignant diseases affecting TMJ-OA assessment
• previous invasive or surgical treatments of TMJ unrelated to OA
• edentulous patients
• pregnancy

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Faculty of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gözde Işık

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: April 2, 2019
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)