Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging (TMD)

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.

Study Overview

• Status: Unknown
• Conditions: Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing); Osteopathy in Temporomandibular Disorders
• Intervention / Treatment: Other: Occlusal Splint Treatment; Other: Osteopathic Manual Treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ataşehir
    • İstanbul, Ataşehir, Turkey, 34755
      • Yeditepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control Group; Occlusal Splint	Other: Occlusal Splint Treatment; Occlusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure.
EXPERIMENTAL: Study Group; Osteopathic Manuel Therapy	Other: Occlusal Splint Treatment; Occlusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure.; Other: Osteopathic Manual Treatment; Osteopathy treats the body as a whole and applied by hands over the related structures of the body. TMJ, Cervical, Thoracal, Lumbar vertebra mobilization was applied as well as the fascial and visceral mobilization. Patients also used occlusal splint for 6 weeks during the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Temporomandibular Joint Pain	10 point scale 0- no pain 10- severe pain	6 weeks after the first measurement
Change in TMJ MR images	Disc-condyle angle, disc and condyle positions were measured over TMJ images	6 weeks after the first measurement
Change in Mandibular Movements	Depression, Left and Right lateralization of the mandibula was measured by the caliper	6 weeks after the first measurement
Change in Cervical Movement	Cervical Region range of motions was measured by a goniometer	6 weeks after the first measurement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in bodily pain	10 point scale 0- no pain 10- severe pain	6 weeks after the first measurement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Life Quality score	A high score corresponds to a good quality of life	6 weeks after the first measurement
Change in sleep quality score	A high score corresponds to a low quality of the sleep	6 weeks after the first measurement

Collaborators and Investigators

• Sponsor: Yeditepe University

Publications and helpful links

General Publications

• 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
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2018
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ANTICIPATED): August 30, 2020

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (ACTUAL): July 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 10, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Disease; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: ACorekci

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No