Injection of Tenoxicam Versus Arthrocentesis Alone in the Treatment of Temporomandibular Joint Osteoarthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Intra-articular Injection of Tenoxicam After Arthrocentesis Heal Outcomes of Temporomandibular Joint Osteoarthritis? A Randomized Clinical Trial

Conditions
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Arthrocentesis

Intervention / Treatment
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* Drug: Tenoxicam Injectable Product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tenoxicam<br>The Tenoxicam group (n:16) received both arthrocentesis and a 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint. | Drug: Tenoxicam Injectable Product<br>* After arthrocentesis procedure, 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint<br>* Other names: Arthrocentesis;|
| Active Comparator: Control<br>Only arthrocentesis was given to patients in the control group | Drug: Tenoxicam Injectable Product<br>* After arthrocentesis procedure, 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint<br>* Other names: Arthrocentesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Tmj (Visual analog scale(VAS) was used.) | Pain scores of Temporomandibular joint on a visual analog scale.To measure the VAS value, a 10-cm-long numbered line was created. The patient chose a point on the line, the corresponding value was measured with a ruler, and a score was given. 0 means no pain and best outcome score; 10 means maximum pain and the worst score. | Change from baseline pain on TMJ at six months | 
| Maximum Mouth Opening(MMO) (A ruler was used) | MMO was gaged with a ruler between the incisal edges of the maxillar and mandibular central incisors when the patient open the mouth maximum. The score was written in mm. | Change from baseline maximum mouth opening at six months | 
| Joint sounds (Visual analog scale was used to measure.) | Temporomandibular joint sounds was measured with Visual analog scale (VAS).To measure the VAS value, a 10-cm-long numbered line was created. The patient chose a point on the line, the corresponding value was measured with a ruler, and a score was given. 0 means no sounds and best outcome score; 10 means maximum sound and the worst score. | Change from baseline joint sounds at six months |