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Completed

NCT Number: NCT05497570

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

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.

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Key information

Conditions

Arthrocentesis

Age range

22 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tenoxicam Injectable Product

Drug

After arthrocentesis procedure, 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint

Other names: Arthrocentesis

Primary outcomes

  1. Pain on Tmj (Visual analog scale(VAS) was used.)

    Time frame: Change from baseline pain on TMJ at six months

    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.

  2. Maximum Mouth Opening(MMO) (A ruler was used)

    Time frame: Change from baseline maximum mouth opening at six months

    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.

  3. Joint sounds (Visual analog scale was used to measure.)

    Time frame: Change from baseline joint sounds at six months

    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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2022
Registry last updated
Aug 11, 2022

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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