Comparing Single Needle and Double Needle Arthrocentesis for Temporomandibular Joint Disorders

NCT06757322 | Completed

• 1 other identifier: YYU/06/04.03.2020
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMJ Disc Disorder

Keywords

arthrocentesis; disc displacement without reduction; temporomandibular joint disorders

Outcome Measures

Primary Outcomes (2)

• change in mouth opening

  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.

  Until the 6th month after TMJ Arthrocentesis

• VAS Pain Scor

  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.

  Until the 6th month after TMJ Arthrocentesis

Study Arms (2)

single-needle double cannula arthrocentesis group

ACTIVE COMPARATOR

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.

Procedure: Singel Needle Double Cannula TMJ Arthrocentesis

Double-needle arthrocentesis group

ACTIVE COMPARATOR

Two needles were inserted into the TMJ and washed.

Procedure: Double Needle TMJ Arthrocentesis

Interventions

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.

single-needle double cannula arthrocentesis group

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.

Double-needle arthrocentesis group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, 65080, Turkey (Türkiye)

Location

Related Publications (12)

• Senturk MF, Cambazoglu M. A new classification for temporomandibular joint arthrocentesis techniques. Int J Oral Maxillofac Surg. 2015 Mar;44(3):417-8. doi: 10.1016/j.ijom.2014.11.014. Epub 2014 Dec 17. No abstract available.

  PMID: 25529932 BACKGROUND

• Sequeira J, Rao BHS, Kedia PR. Efficacy of Sodium Hyaluronate for Temporomandibular Joint Disorder by Single-Puncture Arthrocentesis. J Maxillofac Oral Surg. 2019 Mar;18(1):88-92. doi: 10.1007/s12663-018-1093-4. Epub 2018 Feb 27.

  PMID: 30728698 BACKGROUND

• Nagori SA, Jose A, Roychoudhury A. Comparison of intraoperative outcomes with single and double puncture techniques of arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2020 Oct;58(8):928-932. doi: 10.1016/j.bjoms.2020.04.011. Epub 2020 Jul 16.

  PMID: 32684314 BACKGROUND

• Folle FS, Poluha RL, Setogutti ET, Grossmann E. Double puncture versus single puncture arthrocentesis for the management of unilateral temporomandibular joint disc displacement without reduction: A randomized controlled trial. J Craniomaxillofac Surg. 2018 Dec;46(12):2003-2007. doi: 10.1016/j.jcms.2018.10.015. Epub 2018 Oct 26.

  PMID: 30446325 BACKGROUND

• Nagori SA, Bansal A, Jose A, Roychoudhury A. Comparison of outcomes with the single-puncture and double-puncture techniques of arthrocentesis of the temporomandibular joint: An updated systematic review and meta-analysis. J Oral Rehabil. 2021 Sep;48(9):1056-1065. doi: 10.1111/joor.13228. Epub 2021 Jul 23.

  PMID: 34273184 BACKGROUND

• Senturk MF, Tuzuner-Oncul AM, Cambazoglu M. Prospective short term comparison of outcomes after single or double puncture arthrocentesis of the temporomandibular joint. Br J Oral Maxillofac Surg. 2016 Jan;54(1):26-9. doi: 10.1016/j.bjoms.2015.11.004. Epub 2015 Nov 30.

  PMID: 26782027 BACKGROUND

• Bayramoglu Z, Tozoglu S. Comparison of single- and double-puncture arthrocentesis for the treatment of temporomandibular joint disorders: A six-month, prospective study. Cranio. 2021 Mar;39(2):151-156. doi: 10.1080/08869634.2019.1603796. Epub 2019 Apr 25.

  PMID: 31021311 BACKGROUND

• Talaat W, Ghoneim MM, Elsholkamy M. Single-needle arthrocentesis (Shepard cannula) vs. double-needle arthrocentesis for treating disc displacement without reduction. Cranio. 2016 Sep;34(5):296-302. doi: 10.1080/08869634.2015.1106810. Epub 2016 Apr 13.

  PMID: 27077267 BACKGROUND

• Senturk MF, Yazici T, Gulsen U. Techniques and modifications for TMJ arthrocentesis: A literature review. Cranio. 2018 Sep;36(5):332-340. doi: 10.1080/08869634.2017.1340226. Epub 2017 Jun 15.

  PMID: 28618972 BACKGROUND

• Siewert-Gutowska M, Pokrowiecki R, Kaminski A, Zawadzki P, Stopa Z. State of the Art in Temporomandibular Joint Arthrocentesis-A Systematic Review. J Clin Med. 2023 Jun 30;12(13):4439. doi: 10.3390/jcm12134439.

  PMID: 37445474 BACKGROUND

• Alkan A, Bas B. The use of double-needle canula method for temporomandibular joint arthrocentesis: clinical report. Eur J Dent. 2007 Jul;1(3):179-82.

  PMID: 19212563 BACKGROUND

• Tvrdy P, Heinz P, Pink R. Arthrocentesis of the temporomandibular joint: a review. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Mar;159(1):31-4. doi: 10.5507/bp.2013.026. Epub 2013 Apr 10.

  PMID: 23579112 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 3, 2025
• Study Start: January 1, 2022
• Primary Completion: March 1, 2022
• Study Completion: October 30, 2022
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)