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

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Arthrocentesis of the temporomandibular joint
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Arthrocentesis, Closed lock, Stabilization splint

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: The patients; 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.

Sites / Locations

  • Tokat Gaziosmanpasa University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chronic Closed-Lock

Acute Closed-Lock

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2023
Last Updated
January 3, 2023
Sponsor
Tokat Gaziosmanpasa University
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1. Study Identification

Unique Protocol Identification Number
NCT05671549
Brief Title
Combined Arthrocentesis and Occlusal Splint Therapy for Closed Locks of the TMJ
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
June 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tokat Gaziosmanpasa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Arthrocentesis, Closed lock, Stabilization splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Closed-Lock
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acute Closed-Lock
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Arthrocentesis of the temporomandibular joint
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline Pain intensity with Visual analog scale
Description
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.
Time Frame
At the initial visit before arthrocentesis procedure.
Title
Baseline Pain intensity with McGill pain questionnaire
Description
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.
Time Frame
At the initial visit before arthrocentesis procedure.
Title
Change From Baseline Maximum Mouth Opening on Postoperative Follow Up Visits
Description
All patients' maximal mouth opening were measured and recorded as the distance between upper and lower right central incisors.
Time Frame
At the initial visit, at the session of arthrocentesis postoperatively, at the first week
Title
Postoperative Pain intensity with Visual analog scale
Description
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.
Time Frame
At first week follow-up visit
Title
Postoperative Pain intensity with McGill pain questionnaire
Description
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.
Time Frame
At first week follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: The patients; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet K. Tümer, AssocProfDr
Organizational Affiliation
Alanya Alaaddin Keykubat University
Official's Role
Study Director
Facility Information:
Facility Name
Tokat Gaziosmanpasa University, Faculty of Dentistry
City
Tokat
ZIP/Postal Code
60100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data regarding participants were made available in the manuscript
Citations:
PubMed Identifier
33028488
Citation
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.
Results Reference
background
PubMed Identifier
28222947
Citation
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.
Results Reference
result

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

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