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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04468464
Other study ID # ACorekci
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 15, 2018
Est. completion date August 30, 2020

Study information

Verified date July 2020
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 19
Est. completion date August 30, 2020
Est. primary completion date September 20, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Disease
  • Joint Diseases
  • Osteopathy in Temporomandibular Disorders
  • Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing)
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
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.

Locations

Country Name City State
Turkey Yeditepe University Istanbul Atasehir

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in Life Quality score A high score corresponds to a good quality of life 6 weeks after the first measurement
Other Change in sleep quality score A high score corresponds to a low quality of the sleep 6 weeks after the first measurement
Primary Change in Temporomandibular Joint Pain 10 point scale 0- no pain 10- severe pain 6 weeks after the first measurement
Primary Change in TMJ MR images Disc-condyle angle, disc and condyle positions were measured over TMJ images 6 weeks after the first measurement
Primary Change in Mandibular Movements Depression, Left and Right lateralization of the mandibula was measured by the caliper 6 weeks after the first measurement
Primary Change in Cervical Movement Cervical Region range of motions was measured by a goniometer 6 weeks after the first measurement
Secondary Changes in bodily pain 10 point scale 0- no pain 10- severe pain 6 weeks after the first measurement