NCT06041633

Brief Summary

TMD (temporomandibular disorders) is the name for a collective syndrome of disorders that includes abnormal function of the muscles of mastication, the temporomandibular joints and surrounding structures. It is one of the most significant causes of orofacial pain, along with dental pain. In TMD syndrome, the cause of pain is often due to overloading of the masticatory muscles rather than primary changes in the joints themselves. Nowadays, doctors who treat patients with TMD have no doubt that one of the very important etiological factors of this condition is psycho-emotional disorders (excessive nervous excitability, anxiety, depression), which has been confirmed by numerous authors of studies on this subject \[4-11\]. The etiology of TMD is complex and multifactorial. Numerous factors may also contribute to the development of the disorder. An important factor affecting the state of masticatory function is an increase in stress levels (psycho-emotional tension). Structures such as the hypothalamus, reticular formation and limbic system have a decisive influence on the emotional state of each patient The activity of the limbic system, which governs the emotions of adults, and the additional connections of the gamma loops to the masticatory muscles, determine that increased emotional tension translates into a significant increase in the "contractile" activity of the masticatory muscles. TMD and functional disorder of the masticatory muscles are the most common complaint of the patients, seeking treatment in dental office. The two main symptoms of TMD problems are pain and dysfunction. Myalgia -the most common cause is an increased level of muscle use. It is related to vasocontraction of relevant arteries and accumulation of metabolic waste product in the muscles. Activities such as daytime clenching of the teeth and bruxism, habits of chewing gum, biting lips, finger nails or cheeks are factors that cause significant strain on the masticatory muscles and temporomandibular joints.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

September 11, 2023

Last Update Submit

September 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionanire

    The questionnaire survey includes a total of 30 questions, regarding the emotional state of the of the respondents over the past 4 weeks such as lowered mood, states of emotional irritability, feelings of sadness, lack of desire for daily activities, lack of concentration, or desire for self-isolation and critical thoughts toward one's own person person, or nervousness, fearfulness. Responses in each question included: \* no, \* a few times in the past 4 weeks, \*a few times during the week, and \*continuously/continually. The scores for each question were: 0 points for most favorable response and 4 points for the most unfavorable patient response. The result of the questionnaire was divided into four sections; A, B, C,D.

    2021-2023

Study Arms (2)

Clinical

One hundred and thirty patients diagnosed with TMD constituted the study group (group I)

Diagnostic Test: Clinical

Control

One hundred and thirty patients were excluded from having TMD based on the RDC/ TMD questionnaire, and these patients constituted the control group (group II).

Diagnostic Test: Clinical

Interventions

ClinicalDIAGNOSTIC_TEST

Questionnaire

ClinicalControl

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of Patients of University Clinic

You may qualify if:

  • (i) good general health, with no craniofacial trauma in the last 5 years and without severe mental conditions (ii) the presence of TMD symptoms (pain in the masticatory muscles, limitation of mouth opening range, clicking or popping in the temporomandibular joints. For control group there was absences of these symptoms.
  • (iii) consent of the patient to participate in the research project

You may not qualify if:

  • (i). willingness to resign out of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniwersytecka Klinika Stomatologiczna

Krakow, 31-155, Poland

RECRUITING

Related Publications (1)

  • Pihut ME, Kostrzewa-Janicka J, Orczykowska M, Bieganska-Banas J, Gibas-Stanek M, Gala A. Initial assessment of the psycho-emotional state of patients with temporomandibular disorders: A pilot study. Dent Med Probl. 2024 Jan-Feb;61(1):153-159. doi: 10.17219/dmp/178325.

Central Study Contacts

Andrzej Gala, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Małgorzata Pihut

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

October 1, 2021

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

September 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations