Clinical Trials Directory

Trials / Completed

CompletedNCT05671549

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Tokat Gaziosmanpasa University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREArthrocentesis of the temporomandibular jointArthrocentesis 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.

Timeline

Start date
2019-05-29
Primary completion
2021-08-25
Completion
2022-06-10
First posted
2023-01-04
Last updated
2023-01-04

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05671549. Inclusion in this directory is not an endorsement.