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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: i-PRF
* Procedure: Arthrocentesis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, injectable platelet-rich fibrin, Arthrocentesis