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NCT Number: NCT04810923

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University, Faculty of Dentistry

Izmir, Bornova, 35040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-PRF

Procedure

intra-articular i-PRF injection after arthrocentesis

Arthrocentesis

Procedure

Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.

Primary outcomes

  1. Change of Pain Level

    Time frame: 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 outcomes

  1. Change of maximum mouth opening

    Time frame: 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

  2. Change of lateral movement

    Time frame: 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

  3. Change of protrusive movement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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