Clinical trial NCT05497570: Injection of Tenoxicam Versus Arthrocentesis Alone in the Treatment of Temporomandibular Joint Osteoarthritis
Official title: Does Intra-articular Injection of Tenoxicam After Arthrocentesis Heal Outcomes of Temporomandibular Joint Osteoarthritis? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthrocentesis
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with TMJ-OA.

Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment.

Detailed description: Temporomandibular joint osteoarthritis (TMJ-OA) is a very painful disease that disrupts the patient's comfort of life. Arthrocentesis alone or in combination with intraarticular injections is highly effective in the treatment of TMJ-OA. It reduces pain, increases mouth opening, and improves jaw movements. In intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids, and non-steroidal anti-inflammatory drugs (NSAIDS) are used. Tenoxicam is an NSAID that is used systemically or locally in joint diseases such as acute or chronic inflammatory rheumatoid arthritis and osteoarthritis. It has been reported that its long-lasting analgesic effect and anti-inflammatory effect are higher in intra-articular administration than in oral and intravenous administrations , to our knowledge, there has been no such study analysing the effectiveness of intra-articular application of tenoxicam in patients with TMJ-OA. The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with TMJ-OA.

Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of TMJ-OA
* 18 years of age and older
* Sufficient clinical data at baseline and follow-up.

Exclusion Criteria:

* Uncontrolled systemic disease
* Neurological disease
* Previous TMJ surgery
* Malignant disease in the head and neck region

Primary outcomes:
measure: Pain on Tmj (Visual analog scale(VAS) was used.)
timeFrame: Change from baseline pain on TMJ at six months
measure: Maximum Mouth Opening(MMO) (A ruler was used)
timeFrame: Change from baseline maximum mouth opening at six months
measure: Joint sounds (Visual analog scale was used to measure.)
timeFrame: Change from baseline joint sounds at six months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
affiliation: Ataturk University
name: Zeynep Bayramoglu
role: STUDY_DIRECTOR
References: