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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: i-PRF; Procedure: Arthrocentesis

• Registration Number: NCT04810923
• Lead Sponsor: Ege University

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.

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 Timeline

• Study Start: 2019-04-02
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-02
• Status Verified: 2021-03
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-PRF group	i-PRF	arthrocentesis procedure plus four consecutive intra-articular injection of i-PRF.
Control group	Arthrocentesis	arthrocentesis procedure alone.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ege University, Faculty of Dentistry; 🇹🇷 İzmir, Bornova, Turkey