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

Primary Purpose

Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing), Osteopathy in Temporomandibular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Occlusal Splint Treatment
Osteopathic Manual Treatment
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing) focused on measuring temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

Occlusal Splint

Osteopathic Manuel Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in bodily pain
10 point scale 0- no pain 10- severe pain

Full Information

First Posted
July 6, 2020
Last Updated
July 10, 2020
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04468464
Brief Title
Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging
Acronym
TMD
Official Title
Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing), Osteopathy in Temporomandibular Disorders
Keywords
temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both groups receive splint treatment, but study group also receives osteopathic manual treatment
Masking
InvestigatorOutcomes Assessor
Masking Description
The Radiologist who evaluates the MRI results was blinded about the group of participants and also blinded about the diagnosis of the dentist.
Allocation
Randomized
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Occlusal Splint
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Osteopathic Manuel Therapy
Intervention Type
Other
Intervention Name(s)
Occlusal Splint Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manual Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Temporomandibular Joint Pain
Description
10 point scale 0- no pain 10- severe pain
Time Frame
6 weeks after the first measurement
Title
Change in TMJ MR images
Description
Disc-condyle angle, disc and condyle positions were measured over TMJ images
Time Frame
6 weeks after the first measurement
Title
Change in Mandibular Movements
Description
Depression, Left and Right lateralization of the mandibula was measured by the caliper
Time Frame
6 weeks after the first measurement
Title
Change in Cervical Movement
Description
Cervical Region range of motions was measured by a goniometer
Time Frame
6 weeks after the first measurement
Secondary Outcome Measure Information:
Title
Changes in bodily pain
Description
10 point scale 0- no pain 10- severe pain
Time Frame
6 weeks after the first measurement
Other Pre-specified Outcome Measures:
Title
Change in Life Quality score
Description
A high score corresponds to a good quality of life
Time Frame
6 weeks after the first measurement
Title
Change in sleep quality score
Description
A high score corresponds to a low quality of the sleep
Time Frame
6 weeks after the first measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Yeditepe University
City
İstanbul
State/Province
Ataşehir
ZIP/Postal Code
34755
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
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PubMed Identifier
9503446
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.
Results Reference
background
PubMed Identifier
28029069
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.
Results Reference
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Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging

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