Clinical trial NCT04468464: Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging
Official title: Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing)
Osteopathy in Temporomandibular Disorders
Keywords: temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both groups receive splint treatment, but study group also receives osteopathic manual treatment
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the impact of osteopathic manual treatment in patients with an anterior disc displacement over sleep and health quality, pain scores and the movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.

Detailed description: Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental Hospital patients will be sent to the Radiology Department. MRI images will be gathered in sagittal, coronal and axial plane for each patient before and after treatment. Volunteers will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy + osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle, disc and condyle displacements will be measured and compared inter and intra groups.

Eligibility criteria: Inclusion Criteria:

• Clinical diagnosis of TMD (anterior disc displacement)

Exclusion Criteria:

* Active orthodontic treatment
* Systemic diseases
* Oral or dental pathologies
* Dental implant placement
* Exodontia within 6 months
* Cranial and cervical trauma or surgery
* Taking antidepressant medication
* Contraindication of MRI scans

Primary outcomes:
measure: Change in Temporomandibular Joint Pain
timeFrame: 6 weeks after the first measurement
measure: Change in TMJ MR images
timeFrame: 6 weeks after the first measurement
measure: Change in Mandibular Movements
timeFrame: 6 weeks after the first measurement
measure: Change in Cervical Movement
timeFrame: 6 weeks after the first measurement
Secondary outcomes:
measure: Changes in bodily pain
timeFrame: 6 weeks after the first measurement
Other outcomes:
measure: Change in Life Quality score
timeFrame: 6 weeks after the first measurement
measure: Change in sleep quality score
timeFrame: 6 weeks after the first measurement
Locations:
city: İstanbul
country: Turkey
facility: Yeditepe University
state: Ataşehir
Study officials:
References:
citation: Kalamir, A., Pollard, H., Vitiello, A. L., & Bonello, R. (2007). Manual therapy for temporomandibular disorders: A review of the literature. Journal of Bodywork and Movement Therapies, 11(1), 84-90. https://doi.org/10.1016/j.jbmt.2006.07.003
citation: Kurita H, Kurashina K, Ohtsuka A, Kotani A. Change of position of the temporomandibular joint disk with insertion of a disk-repositioning appliance. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Feb;85(2):142-5. doi: 10.1016/s1079-2104(98)90416-4.
citation: Gesslbauer C, Vavti N, Keilani M, Mickel M, Crevenna R. Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. Disabil Rehabil. 2018 Mar;40(6):631-636. doi: 10.1080/09638288.2016.1269368. Epub 2016 Dec 28.