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

NCT ID: NCT05671549

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-29
• Study Completion Date: 2022-06-10

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.

Detailed Description

The study sample constituted patients diagnosed with DDWoR with limited opening according to the Turkish version of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD Axis 1 questionnaire and examination form). The included patients with DDWoR-induced complaints persisting for more than three months were considered chronic (Group 1), and those with a shorter duration were considered acute (Group 2). For clinical diagnosis of DDWoR, Significant limitation of mouth opening, less than 35 mm assisted mouth opening, less than 4 mm increase in mouth opening with passive stretching, less than 7 mm contralateral movement of the mandible, and deviation of the mandible to the affected side during mouth opening was considered sufficient. The DC/TMD questionnaire and clinical examination diagnoses were confirmed by magnetic resonance images (MRI).

Preoperative and postoperative clinical examinations consisted of recording demographic information, amount of maximum mouth opening (MMO), and determination of McGill Pain Questionnaire (MPQ) and Visual Analog Scale (VAS) scores. MMO values were determined as the distance between the incisal edges of upper and lower central teeth and recorded in millimeters. MPQ scores were obtained with the questionnaire form consisting of four subsections. In the first subsection of the questionnaire, besides the patient's demographic data, the location of the current pain and whether it comes from superficial or deep tissues are questioned. In the second subsection, there are 20-word groups containing 78 words that ask the Sensory (groups 1-10), Affective (groups 11-15), Evaluative (group 16), and Miscellaneous (groups 17-20) components of current pain. In the third subsection, the relationship of pain with time is questioned. There are word groups to determine the continuity of pain, its frequency, and factors that increase or reduce pain. In the fourth subsection, five-word groups ranging from "mild" pain to "unbearable" pain to determine the severity of the pain; There are also six questions to assess the severity of pain that the patient can accept or experience without discomfort, which is also defined as "experienceable=target pain." The obtainable MPQ scores range from 0 to 78. The higher the scores, the greater the pain. Also, preoperative and postoperative VAS scores were obtained by marking a point on a 10 cm line. The score was calculated as the distance in centimeters between the zero and the marked points.

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic Closed-Lock

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.

Group Type: ACTIVE_COMPARATOR

Arthrocentesis of the temporomandibular joint

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Arthrocentesis of the temporomandibular joint

Intervention Type: 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.

Interventions

Arthrocentesis of the temporomandibular joint

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokat Gaziosmanpasa University

OTHER

Sponsor Role: lead

Responsible Party

Aras Erdil

Researcher in the related department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet K. Tümer, AssocProfDr

Role: STUDY_DIRECTOR

Alanya Alaaddin Keykubat University

Locations

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 33028488 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28222947 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36918123 (View on PubMed)

Other Identifiers

83116987-381

Identifier Type: -

Identifier Source: org_study_id