NCT05187325

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 15, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

December 25, 2021

Last Update Submit

March 15, 2022

Conditions

Temporomandibular Joint DisordersMyofascial Trigger Point PainJaw DiseasesPain

Keywords

temporomandibular jointdisc displacement with reductiontrigger pointpain level

Outcome Measures

Primary Outcomes (7)

  • 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

  • bruxism

    bruxism is a stereotyped movement disorder characterized by grinding or clenching of the teeth

    1 day

  • limitation of the movement of the temporomandibular joint

    limitation of the movement of the temporomandibular joint

    1 day

  • temporomandibular joint noises

    noises of the temporomandibular joint

    1 day

  • locking of the temporomandibular joint

    locking of the temporomandibular joint

    1 day

  • 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

  • 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

Study Arms (2)

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.

Other: no intervention

disc displacement with reduction

the participants have only temporomandibular joint disc displacement with reduction.

Other: no intervention

Interventions

no interventionOTHER

there is no intervention

disc displacement with reductionmyofascial trigger point and disc displacement with reduction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersMyofascial Pain SyndromesJaw DiseasesPain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 11, 2022

Study Start

December 15, 2021

Primary Completion

February 15, 2022

Study Completion

February 17, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

TU(1)