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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
intra-articular i-PRF injection after arthrocentesis
Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.
Ege University, Faculty of Dentistry
Izmir, Bornova, Turkey (Türkiye)
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).
Time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
Change of maximum mouth opening
Maximum mouth opening was assessed by measuring the distance between the incisal border of upper and lower central incisors
Time frame: 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
Time frame: 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
Time frame: at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month
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