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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-PRF group | Experimental | arthrocentesis procedure plus four consecutive intra-articular injection of i-PRF. |
|
| Control group | Experimental | arthrocentesis procedure alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-PRF | Procedure | intra-articular i-PRF injection after arthrocentesis |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gözde Işık | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University, Faculty of Dentistry | Izmir | Bornova | 35040 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069237 | Arthrocentesis |
| ID | Term |
|---|---|
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Arthrocentesis |
| Procedure |
Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint. |
|
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 |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |