The Clinical Effects of Myofascial Trigger Points in Disc Replacement With Reduction

March 15, 2022 updated by: Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital

The Effect of Myofascial Trigger Points on Clinical Symptoms, Pain and Limitation of Temporomandibular Joint Function in Disc Displacement With Reduction

This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. These two groups will be compared for clinical findings, pain severity and limitation of the temporomadibular function.

Study Overview

Detailed Description

This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. The participants' ages will be between 18-65 years of both genders.

These two groups will be compared for clinical findings with DC/TMD Axis I- Symptom Questionnaire, pain levels in the last 1 month with DC/TMD Axis II-Graded Chronic Pain Scale, and limitation of the temporomadibular function with DC/TMD Axis II-Jaw Functional Limitation Scale-8.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34303
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The participants who ages between 18-65 years of both genders with disc displacement with reduction with/ without myofascial trigger points in master muscles will be included in the study.

Description

Inclusion Criteria:

  • 18-65 years old of both genders.
  • Presence of disc displacement with reduction with/without myofascial trigger points in master muscles.
  • Being accepted of the participation in the study.

Exclusion Criteria:

  • Lack of cognitive ability to understand test instructions, illiteracy, aphasia, presence of a known psychiatric illness
  • Refusal to participate in the study
  • Patients under the age of 18 and over the age of 65
  • Having other temporomandibular joint disorders other than the diagnosis of RDD and/or myofascial trigger points

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
myofascial trigger point and disc displacement with reduction
the participants have myofascial trigger points in master muscle and also temporomandibular joint disc displacement with reduction.
there is no intervention
disc displacement with reduction
the participants have only temporomandibular joint disc displacement with reduction.
there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mouth opening distance
Time Frame: 1 day
Maximal opening of mouth is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite.
1 day
bruxism
Time Frame: 1 day
bruxism is a stereotyped movement disorder characterized by grinding or clenching of the teeth
1 day
limitation of the movement of the temporomandibular joint
Time Frame: 1 day
limitation of the movement of the temporomandibular joint
1 day
temporomandibular joint noises
Time Frame: 1 day
noises of the temporomandibular joint
1 day
locking of the temporomandibular joint
Time Frame: 1 day
locking of the temporomandibular joint
1 day
Graded Chronic pain Scale v.2.0
Time Frame: 1 day
Version 2 of the GCPS includes, in addition to the 3 items for pain intensity and 4 items for function, one item for number of days of pain.
1 day
Jaw Functional Limitation Scale-8
Time Frame: 1 day
The JFLS was initially developed as an 8-item global scale for overall functional limitation of the masticatory system; based on the resultant items and supporting psychometric data, the instrument was re-developed in order to expand measured constructs to also include masticatory limitation, vertical mobility limitation, and verbal and non-verbal communication limitation.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

December 25, 2021

First Submitted That Met QC Criteria

December 25, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It will be decided after the publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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