NCT03065608

Brief Summary

Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures. The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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

January 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

February 17, 2017

Last Update Submit

February 22, 2017

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

  • By means of the CRP-level it will be verified if the temporomandibular joint dysfunctions are associated with inflammations of the temporomandibular joints.

    The aim of the study is to avaluation of the level of C-reactive protein in patients treated prosthetically due to the pain form of temporomandibular joints dysfunction.

    12 months

Study Arms (2)

Study Group

The study group included 36 patients with pain form of dysfunction.

Control Group

The control group consisted of 36 patients with painless form of disorder.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study enrolled a group of 72 patients, aged 21 to 48 years, 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 February 2017, due to the pain and painless form of the temporomandibular joints dysfunction, and acoustic symptoms, accompanied by excessive tension of masticatory muscle. Symptoms persisted from 3 to 12 months prior to beginning of the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Małgorzata Pihut, Associate Professor

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

  • Piotr Ceranowicz, MD,PhD,

    Jagiellonian University

    STUDY CHAIR

  • Andrzej Gala, DDS,PhD,

    Jagiellonian University

    STUDY CHAIR

  • Mieszko Więckiewicz, DMD,PhD,

    Wroclaw Medical University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 28, 2017

Study Start

January 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share