Clinical trial NCT04810923: Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis
Official title: Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
injectable platelet-rich fibrin
Arthrocentesis
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Pain Level
timeFrame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Secondary outcomes:
measure: Change of maximum mouth opening
timeFrame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
measure: Change of lateral movement
timeFrame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
measure: Change of protrusive movement
timeFrame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University, Faculty of Dentistry
state: Bornova
Study officials:
affiliation: Ege University
name: Gözde Işık
role: PRINCIPAL_INVESTIGATOR
References: