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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthrocentesis
• Intervention / Treatment: Drug: Tenoxicam Injectable Product

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tenoxicam; 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; After arthrocentesis procedure, 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint; Other Names: Arthrocentesis
Active Comparator: Control; Only arthrocentesis was given to patients in the control group	Drug: Tenoxicam Injectable Product; After arthrocentesis procedure, 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint; Other Names: Arthrocentesis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Director: Zeynep Bayramoglu, Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): November 7, 2021
• Study Completion (Actual): April 21, 2022

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Tenoxicam
• Other Study ID Numbers: 3525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No