NCT03736408

Brief Summary

Temporomandibular joint dysfunction (TMJD) includes disorders of the masticatory muscles in the stomatognathic system, temporomandibular joints and the surrounding structures. They are often associated with abnormal conditions of occlusion. The term "functional disorders" does not include all diseases of the muscular and joint system, like inflammatory, degenerative changes and cancer lesions of the muscles (multiple sclerosis, tetany, dermatomyositis). They are often the result of excessive and prolonged muscle hyperactivities and excessive work that cause non-physiological loads occurring in temporomandibular joints

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

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

Study Start

First participant enrolled

May 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 7, 2018

Last Update Submit

November 8, 2018

Conditions

Keywords

temporomandibular joint dysfunctionpain formtreatmentepidemiologcal assessment

Outcome Measures

Primary Outcomes (1)

  • Comparison of pain and painless type of the temporomandibular joint disorders.

    The aim of the study was to carry out a retrospective assessment of the frequency of the pain form of functional disorders based on the analysis of medical records (results of a physical examination and a specialized functional test) of patients treated at the Consulting Room of Temporomandibular Joint Dysfunction.

    12 months

Study Arms (2)

1. Group without Pain - TMJ disorders symptoms

1\. The symptoms concerning joints were: the type of sound symptoms (clicking or popping), their frequency and the phase of the movement of lowering and lifting the jaw during which they occurred, occurrence of the tension type headache or back pain. Hypertension of the mastication muscles is frequently connected with a parafunction activity like grinding or clenching the teeth, which cause abnormal pressure on the joints

2. Group with Pain and symptoms TMJ disorder

The pain form of the disease is manifested by spontaneous pain in the preaural region, accompanied by pain or tenderness of the mastication muscle. Pain that appears during palpation examination of temporomandibular joints is frequently not related to inflammation of the soft tissue around the temporomandibular joints, as it is claimed by several authors of the paper. The cause of this problem is a long-term overload of soft tissue causally associated with excessive muscle tension, that sometimes even persists for years

Eligibility Criteria

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

The study enrolled a group of 334 patients of both sexes, who reported to the prosthodontic treatment in Consulting Room of Temporomandibular Joint Dysfunction at Dental Institute at Jagiellonian University in Cracow, between January 2015 to June 2018, due to the pain and painless form of the temporomandibular joints dysfunctions.

You may qualify if:

  • pain and painless form of temporomandibular joints dysfunction,
  • required age range (\>18 years)
  • good general state of health

You may not qualify if:

  • the will of the patient,
  • emergence of general diseases,
  • trauma,
  • local inflammation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jagiellonian University Department of Prosthetic Dentistry

Krakow, Lesser Poland Voivodeship, 31-155, Poland

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Małgorzata Pihut, Prof.

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Prosthetic Dentistry, Clinical Professor

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 9, 2018

Study Start

May 1, 2018

Primary Completion

October 1, 2018

Study Completion

October 30, 2018

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations