Clinical trial NCT06756412: The Effects of an Exercise Regimen Following TMJ Arthrocentesis
Official title: Investigation of the Efficacy of an Exercise Regimen Following Arthrocentesis in the Management of Temporomandibular Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Disorders
Keywords: Temporomandibular Joint Disorders
Arthrocentesis
Temporomandibular joint
Exercise Therapy
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Admitted patients with the history of limited mouth opening and TMJ arthralgia

Brief summary: The goal of this study is to evaluate the short- and long-term effects of a self-administered exercise program on pain levels, jaw movement range, and jaw function in patients with temporomandibular joint (TMJ) disorders. The main question it aims to answer is:

Does adding a self-administered exercise program to arthrocentesis improve pain, mouth opening, and jaw function compared to arthrocentesis alone in patients with TMJ disorders?

Participants with acute or chronic TMJ pain lasting at least three months and limited mouth opening will undergo arthrocentesis, with one group also following an exercise regimen. Outcomes will be assessed over a 6-month follow-up period.


Eligibility criteria: Inclusion Criteria:

* Limited mouth opening (\<35mm) and joint pain complaints according to the DC/TMD examination form,
* Pain complaints for 3 months or longer,
* Able to understand Turkish in spoken and written language,
* Patients who can read the written consent form and give signed consent will be included in the study.

Exclusion Criteria:

* Those with serious neurological disorders,
* Those with autoimmune disorders involving muscles or joints,
* Those with a history of alcoholism,
* Patients diagnosed with malignancy,
* Patients who have previously undergone surgery or radiotherapy in the head and neck region,
* Those with other TMD diagnoses that do not cause restriction or pain in mouth opening,
* Those who have received other treatments for the neck or TMJ regions in the last 3 months,
* Those with a history of surgical treatment for the temporomandibular joint,
* Those with a history of allergy to any of the agents used in the treatment process,
* Those who use drugs that affect the musculoskeletal system, and
* Pregnant patients will not be included in the study.

Primary outcomes:
measure: Maximum Amount of Mouth Opening
timeFrame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
measure: Pain Intensity
timeFrame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
Secondary outcomes:
measure: Jaw Function Limitation
timeFrame: Measurements will be conducted at five time points, from enrollment through the 6-month follow-up period: (1) pre-arthrocentesis, (2) postoperative 1st week, (3) postoperative 1st month, (4) postoperative 3rd month, and (5) postoperative 6th month.
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University, Faculty of Dentistry
Study officials:
affiliation: Uşak University
name: Mehmet A Güngör, Prof Dr
role: STUDY_DIRECTOR
References:
citation: Lindfors E, Arima T, Baad-Hansen L, Bakke M, De Laat A, Giannakopoulos NN, Glaros A, Guimaraes AS, Johansson A, Le Bell Y, Lobbezoo F, Michelotti A, Muller F, Ohrbach R, Wanman A, Magnusson T, Ernberg M. Jaw Exercises in the Treatment of Temporomandibular Disorders-An International Modified Delphi Study. J Oral Facial Pain Headache. 2019 Fall;33(4):389-398. doi: 10.11607/ofph.2359. Epub 2019 Jun 24.
citation: Hosgor H, Bas B, Celenk C. A comparison of the outcomes of four minimally invasive treatment methods for anterior disc displacement of the temporomandibular joint. Int J Oral Maxillofac Surg. 2017 Nov;46(11):1403-1410. doi: 10.1016/j.ijom.2017.05.010. Epub 2017 Jun 9.
citation: Bas B, Kazan D, Kutuk N, Gurbanov V. The Effect of Exercise on Range of Movement and Pain After Temporomandibular Joint Arthrocentesis. J Oral Maxillofac Surg. 2018 Jun;76(6):1181-1186. doi: 10.1016/j.joms.2018.01.003. Epub 2018 Jan 12.