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

NCT05497570 | Completed Phase 1

• 1 other identifier: 3525
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthrocentesis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Tenoxicam

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

Only arthrocentesis was given to patients in the control group

Drug: Tenoxicam Injectable Product

Interventions

Tenoxicam Injectable Product DRUG

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

Also known as: Arthrocentesis

Control; Tenoxicam

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Bayramoglu Z, Yavuz GY, Keskinruzgar A, Koparal M, Kaya GS. Does intra-articular injection of tenoxicam after arthrocentesis heal outcomes of temporomandibular joint osteoarthritis? A randomized clinical trial. BMC Oral Health. 2023 Mar 8;23(1):131. doi: 10.1186/s12903-023-02852-z.

  PMID: 36890529 DERIVED

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Zeynep Bayramoglu

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 11, 2022
• Study Start: May 3, 2019
• Primary Completion: November 7, 2021
• Study Completion: April 21, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)