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Completed

NCT Number: NCT06757322

Comparing Single Needle and Double Needle Arthrocentesis for Temporomandibular Joint Disorders

The purpose of this study was to compare the clinical success and efficacy of single-needle, double-cannula arthrocentesis with conventional arthrocentesis techniques in patients with temporomandibular joint disorders. Patients with nonreducible disc displacement complained of limited mouth opening and/or pain. All treated patients had baseline and follow-up (with mouth opening and VAS). Comparisons were made within and between groups.

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Key information

Conditions

TMJ Disc Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, 65080, Turkey (Türkiye)

About this study

The patients included in the study were evaluated in the preoperative, 1week, 1-3, and 6 months after the procedure. Double-needle group: two needles were inserted into the joint and washed. In the single-needle group, two needles were bent (from their lower parts) before the procedure and their pointed ends were joined by placing acrylic on the plastic parts from a single point. The resulting combined needle was directed to the upper joint space and washed. 13 underwent single-needle double cannula arthrocentesis and 15 underwent double needle arthrocentesis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with complaints of pain and restricted mouth opening and who had not received any previous treatment.
  • Patients with a diagnosis of disc displacement without reduction characterized by persistent or frequent TMJ pain, history of joint clicking, limited mouth opening with deviation to the affected side, limited lateral movement to the opposite side, limited protrusive movements with deviation to the affected side were included.

Exclusion criteria

  • Patients with systemic inflammatory joint disease, facial growth disorder, and direct trauma to the TMJ were excluded.

Treatment and study plan

Singel Needle Double Cannula TMJ Arthrocentesis

Procedure

Artocentesis describes the lavage of the TMJ by introducing a saline/ringer lactate solution through a needle inserted into the upper joint cavity. TMJ arthrocentesis was first introduced as a double needle entry method by Nitzan et al in 1991. The single needle technique was developed by Singh and Varghese and introduced in 2013. The single needle method is a more simplified modification of the first method.

Double Needle TMJ Arthrocentesis

Procedure

Artocentesis describes the lavage of the TMJ by introducing a saline/ringer lactate solution through a needle inserted into the upper joint cavity. TMJ arthrocentesis was first introduced as a double needle entry method by Nitzan et al in 1991.

Primary outcomes

  1. change in mouth opening

    Time frame: Until the 6th month after TMJ Arthrocentesis

    The maximum mouth opening of the patients was noted in centimeters before arthrocentesis and in the control sessions, and the changes between the sessions were compared.

  2. VAS Pain Scor

    Time frame: Until the 6th month after TMJ Arthrocentesis

    The VAS pain assessments of the patients before and during the arthrocentesis and control sessions were noted and changes between sessions were compared. The VAS score is an assessment in which we note the patient's pain assessment between 0 and 10. '0' means no pain, while '10' means the worst possible pain. As the number increases, it indicates that the patient's pain increases.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study title

Comparison of Single Needle-Double Cannula and Double Needle Arthrocentesis in Temporomandibular Joint Disorders

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

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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