Combined Arthrocentesis and Occlusal Splint Therapy for Closed Locks of the TMJ

NCT05671549 | Completed

• 1 other identifier: 83116987-381
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective cohort study is to evaluate the effectiveness of combined arthrocentesis and occlusal stabilization splint therapy in patients diagnosed with disc displacement without reduction of temporomandibular joint-induced closed locks. The main questions it aims to answer are:

• Is there a difference in the treatment response between chronic and acute closed-lock conditions?
• On which dimensions of pain did the treatment have positive effects? Participants will be preoperatively examined and assigned to one of the two study groups.
• All participants undergo a single session of TMJ arthrocentesis.
• Following the arthrocentesis session, all participants will use preoperatively fabricated occlusal splints.
• Participants will be recalled in one week to evaluate the outcomes. Researchers will compare acute and chronic closed-lock groups to see if there are differences between pain intensities and mouth-opening amounts postoperatively.

Conditions

Temporomandibular Joint Disorders

Keywords

Arthrocentesis; Closed lock; Stabilization splint

Outcome Measures

Primary Outcomes (5)

• Baseline Pain intensity with Visual analog scale

  The pain intensity measurement was performed with the Visual analog scale (VAS), in which 0 referred to 'no pain,' 5 referred to 'moderate pain,' and ten referred to 'excruciating pain.' The patients were asked to mark their pain intensities on the VAS scale.

  At the initial visit before arthrocentesis procedure.

• Baseline Pain intensity with McGill pain questionnaire

  The pain intensity measurement was performed with the McGill Pain Questionnaire form. According to the word groups chosen by the participants, the total score of the questionnaire varies between 0-78. An increase in the total score is interpreted as the severity of pain intensity.

  At the initial visit before arthrocentesis procedure.

• Change From Baseline Maximum Mouth Opening on Postoperative Follow Up Visits

  All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.

  At the initial visit, at the session of arthrocentesis postoperatively, at the first week

• Postoperative Pain intensity with Visual analog scale

  The pain intensity measurement was performed with the Visual analog scale (VAS), in which 0 referred to 'no pain,' 5 referred to 'moderate pain,' and ten referred to 'excruciating pain.' The patients were asked to mark their pain intensities on the VAS scale.

  At first week follow-up visit

• Postoperative Pain intensity with McGill pain questionnaire

  The pain intensity measurements were performed with the McGill Pain Questionnaire form. According to the word groups chosen by the participants, the total score of the questionnaire varies between 0-78. An increase in the total score is interpreted as the severity of pain intensity.

  At first week follow-up visit

Study Arms (2)

Chronic Closed-Lock

ACTIVE COMPARATOR

The participants will be enrolled in this group regarding the duration (longer than three months) of their symptoms. The allocated participants will undergo one session of the arthrocentesis procedure. The prefabricated occlusal stabilization splints will be applied. The participants' preoperative, postoperative immediate, and postoperative seventh-day pain intensities and maximum mouth-opening amounts will be recorded and analyzed.

Procedure: Arthrocentesis of the temporomandibular joint

Acute Closed-Lock

ACTIVE COMPARATOR

The participants will be enrolled in this group regarding the duration (shorter than three months) of their symptoms. The allocated participants will undergo one session of the arthrocentesis procedure. The prefabricated occlusal stabilization splints will be applied. The participants' preoperative, postoperative immediate, and postoperative seventh-day pain intensities and maximum mouth-opening amounts will be recorded and analyzed.

Procedure: Arthrocentesis of the temporomandibular joint

Interventions

Arthrocentesis of the temporomandibular joint PROCEDURE

Arthrocentesis of the temporomandibular joint is a minimally invasive method performed under local anesthesia to irrigate the upper temporomandibular joint cavity with biocompatible substances. The procedure aims to wash out intra-articular inflammatory substances, reduce pain and restore the function of the related joint.

Acute Closed-Lock; Chronic Closed-Lock

Eligibility Criteria

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

You may qualify if:

• individuals over the age of 18
• completion of the arthrocentesis treatment without any complications;
• the presence of preoperative information and postoperative follow-up data;
• persistent complaints despite conservative methods (behavioral modification, diet restrictions, non-steroid anti-inflammatory drugs, and physical therapy) for at least three months.

You may not qualify if:

• diagnosed with any connective tissue, neurological, dermatological, inflammatory diseases, and TMD other than DDWoR,
• who underwent TMJ surgeries, arthrocentesis procedures, TMJ ankylosis surgery,
• previously used occlusal splints,
• who developed complications in the application of arthrocentesis in the current study (low-volume lavage, extravasation, inability to reach the upper joint space, e.g.),
• with lack of teeth to affect the fabrication of the occlusal stabilization splint,
• with a history of radiotherapy of the head and neck.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (3)

• Hosgor H. Is arthrocentesis plus hyaluronic acid superior to arthrocentesis alone in the treatment of disc displacement without reduction in patients with bruxism? J Craniomaxillofac Surg. 2020 Nov;48(11):1023-1027. doi: 10.1016/j.jcms.2020.07.008. Epub 2020 Jul 25.

  PMID: 33028488 BACKGROUND

• Tatli U, Benlidayi ME, Ekren O, Salimov F. Comparison of the effectiveness of three different treatment methods for temporomandibular joint disc displacement without reduction. Int J Oral Maxillofac Surg. 2017 May;46(5):603-609. doi: 10.1016/j.ijom.2017.01.018. Epub 2017 Feb 20.

  PMID: 28222947 RESULT

• Erdil A, Demirsoy MS, Tumer MK. Evaluation of the effects of arthrocentesis combined with occlusal stabilization splint on disc displacement without reduction-induced acute and closed lock. A prospective cohort study. J Stomatol Oral Maxillofac Surg. 2023 Oct;124(5):101438. doi: 10.1016/j.jormas.2023.101438. Epub 2023 Mar 12.

  PMID: 36918123 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehmet K. Tümer, AssocProfDr

  Alanya Alaaddin Keykubat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in the related department

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: January 4, 2023
• Study Start: May 29, 2019
• Primary Completion: August 25, 2021
• Study Completion: June 10, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)