Osteoarthritis
Conditions
Keywords
Osteoarthritis, injectable platelet-rich fibrin, Arthrocentesis
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.
Interventions
PROCEDUREi-PRF
intra-articular i-PRF injection after arthrocentesis
PROCEDUREArthrocentesis
Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed