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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05187325
Other study ID # KAEK/2021.11.309
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date February 17, 2022

Study information

Verified date March 2022
Source Kanuni Sultan Suleyman Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date February 17, 2022
Est. primary completion date February 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
there is no intervention

Locations

Country Name City State
Turkey Kanuni Sultan Suleyman Training and Research Hospital Istanbul Kucukcekmece

Sponsors (1)

Lead Sponsor Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary mouth opening distance 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
Primary bruxism bruxism is a stereotyped movement disorder characterized by grinding or clenching of the teeth 1 day
Primary limitation of the movement of the temporomandibular joint limitation of the movement of the temporomandibular joint 1 day
Primary temporomandibular joint noises noises of the temporomandibular joint 1 day
Primary locking of the temporomandibular joint locking of the temporomandibular joint 1 day
Primary Graded Chronic pain Scale v.2.0 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
Primary Jaw Functional Limitation Scale-8 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
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