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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810923
• Other study ID #: 19-11/47
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: December 2, 2019

Study information

• Verified date: March 2021
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• i-PRF
intra-articular i-PRF injection after arthrocentesis
• Arthrocentesis
Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.

Locations

Country	Name	City	State
Turkey	Ege University, Faculty of Dentistry	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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