- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187325
The Clinical Effects of Myofascial Trigger Points in Disc Replacement With Reduction
The Effect of Myofascial Trigger Points on Clinical Symptoms, Pain and Limitation of Temporomandibular Joint Function in Disc Displacement With Reduction
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kucukcekmece
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Istanbul, Kucukcekmece, Turkey, 34303
- Kanuni Sultan Suleyman Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK/2021.11.309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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