NCT04468464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 6, 2020

Last Update Submit

July 10, 2020

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

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Changes in bodily pain

    6 weeks after the first measurement

Other Outcomes (2)

  • Change in Life Quality score

    6 weeks after the first measurement

  • Change in sleep quality score

    6 weeks after the first measurement

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Occlusal Splint

Other: Occlusal Splint Treatment

Study Group

EXPERIMENTAL

Osteopathic Manuel Therapy

Other: Occlusal Splint TreatmentOther: Osteopathic Manual Treatment

Interventions

Occlusal Splint TreatmentOTHER

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.

Control GroupStudy Group
Osteopathic Manual TreatmentOTHER

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.

Study Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of TMD (anterior disc displacement)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34755, Turkey (Türkiye)

Location

Related Publications (3)

  • 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

    BACKGROUND

  • 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.

    PMID: 9503446BACKGROUND

  • 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.

    PMID: 28029069BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The Radiologist who evaluates the MRI results was blinded about the group of participants and also blinded about the diagnosis of the dentist.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both groups receive splint treatment, but study group also receives osteopathic manual treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 13, 2020

Study Start

September 15, 2018

Primary Completion

September 20, 2019

Study Completion

August 30, 2020

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)