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

Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: i-PRF; Procedure: Arthrocentesis

Detailed Description

The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment procedures were completed by the same experienced surgeon under the local anesthesia. The procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-PRF injection was performed in the test 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35040
      • Ege University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: i-PRF group; arthrocentesis procedure plus four consecutive intra-articular injection of i-PRF.	Procedure: i-PRF; intra-articular i-PRF injection after arthrocentesis
EXPERIMENTAL: Control group; arthrocentesis procedure alone.	Procedure: Arthrocentesis; Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of maximum mouth opening	Maximum mouth opening was assessed by measuring the distance between the incisal border of upper and lower central incisors	at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of lateral movement	Lateral movement was measured from the labioincisal contact between upper central incisors to the same point of lower central incisors	at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of protrusive movement	Protrusive movement was measured from the incisal border of upper central incisors to same point of lower central incisors	at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 2, 2019
• Primary Completion (ACTUAL): December 2, 2019
• Study Completion (ACTUAL): December 2, 2019

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (ACTUAL): March 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Osteoarthritis; Arthrocentesis; injectable platelet-rich fibrin
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 19-11/47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No