NCT04780711

Brief Summary

Temporomandibular joint (TMJ) disorders are common problems in the society and involve the masticator muscles, jaw joint and related structures. Since TMJ disorders affect functions such as eating and speaking, they can cause important problems in the daily life of the patient. Therefore, its diagnosis and treatment are of great importance. In the treatment of these patients, methods such as analgesic and anti-inflammatory drugs, splint, exercise, physical therapy modalities can be applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

March 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

February 21, 2021

Last Update Submit

August 2, 2021

Conditions

Keywords

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (3)

  • Mouth opening

    The patient opens her mouth to the maximum, the lower border of the anterior upper teeth and the distance to the upper border of the lower teeth are measured.

    Baseline

  • Tenderness in the masseter and temporal muscles on deep palpation

    Tenderness in the masseter and temporal muscles on deep palpation

    Baseline

  • Click in the temporomandibular joint

    The patient's temporomandibular joint is palpated, and it is checked whether there is click or popping when opening or closing the mouth.

    Baseline

Study Arms (1)

Diagnostic Group

Demographic data, symptoms for TMJ of the students will be recorded. Physical examination will be included range of motion of temporomandibular joint, right and left TMJ lateral range of motion, whether there is a gradual opening, during deflection and deviation during the opening and subluxation for palpation and measurements. Opening and closing clicks, crepitation and popping will be recorded during palpation. Deep palpation of the skin, masseter and temporal muscles will be determined, posture analysis will be recorded and dental interventions, missing teeth, orthodontic treatments and bruxism histories will be taken. An appropriate diagnosis will be determined for students who are found to have pathology as a result of all these examinations and information about this diagnosis will be provided.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

We planned to include 500 volunteer students between the ages of 18-35, studying at Bolu Abant Izzet Baysal University Faculty of Medicine, with or without TMJ symptoms and agreeing to participate in the study.

You may qualify if:

  • Being a medical student
  • Being between the ages of 18-35

You may not qualify if:

  • Students who do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Yakşi

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Elif Yakşi, MD

    Abant İzzet Baysal University Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 21, 2021

First Posted

March 3, 2021

Study Start

March 20, 2021

Primary Completion

July 28, 2021

Study Completion

August 1, 2021

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations