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Status unknownNCT04468464TMDUpdated Jul 13, 2020

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

An interventional study of Occlusal Splint Treatment and Osteopathic Manual Treatment in Temporomandibular Disorders, Articular Disc Disorder (Reducing or Non-Reducing) and Osteopathy in Temporomandibular Disorders, sponsored by Yeditepe University. Status unknown at 1 site in Turkey. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-13.

Sponsored by Yeditepe University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Sep 2018, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • temporomandibular disorders, anterior disc displacement with reduction, MRI analyses, Osteopathy
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's planned enrollment of 19 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Yeditepe University is the lead sponsor of 127 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of TMD (anterior disc displacement)

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
19 participants (estimated)

Study arms

  • Active comparator
    Control Group

    Occlusal Splint

    Other: Occlusal Splint Treatment

  • Experimental
    Study Group

    Osteopathic Manuel Therapy

    Other: Occlusal Splint Treatment · Other: Osteopathic Manual Treatment

Interventions

  • OtherOcclusal 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.

  • OtherOsteopathic 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.

06

What researchers measure

Primary outcomes

  1. Change in Temporomandibular Joint Pain

    10 point scale 0- no pain 10- severe pain

    Time frame: 6 weeks after the first measurement

  2. Change in TMJ MR images

    Disc-condyle angle, disc and condyle positions were measured over TMJ images

    Time frame: 6 weeks after the first measurement

  3. Change in Mandibular Movements

    Depression, Left and Right lateralization of the mandibula was measured by the caliper

    Time frame: 6 weeks after the first measurement

  4. Change in Cervical Movement

    Cervical Region range of motions was measured by a goniometer

    Time frame: 6 weeks after the first measurement

Secondary outcomes

  1. Changes in bodily pain

    10 point scale 0- no pain 10- severe pain

    Time frame: 6 weeks after the first measurement

Other outcomes

  1. Change in Life Quality score

    A high score corresponds to a good quality of life

    Time frame: 6 weeks after the first measurement

  2. Change in sleep quality score

    A high score corresponds to a low quality of the sleep

    Time frame: 6 weeks after the first measurement

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Study locations

1 site
  • Yeditepe University
    İstanbul, Ataşehir 34755, Turkey
08

References and documents

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. PubMed 9503446 ↗
  • 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. PubMed 28029069 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04468464
Lead sponsor
Yeditepe University
Responsible party
Sponsor
First posted
Jul 13, 2020
Start date
Sep 15, 2018
Primary completion
Sep 20, 2019
Completion
Aug 30, 2020 (estimated)
Last update
Jul 13, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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