Genetic Polymorphisms and Their Association With Temporomandibular Disorders (GenPolTMD)

January 4, 2021 updated by: Iva Alajbeg, Croatian Science Foundation
Temporomandibular disorders (TMD) are the most common orofacial pain disorders of non-dental origin with the prevalence of 6.1-10.2%, and incidence of 3.9%. Observable pathology is mostly absent, and the etiology often remains unknown. Since some other painful conditions of unknown origin (eg. fibromyalgia), also imply genetic factors, the aim of the study is to investigate genetic predisposition in relation to the risk for TMD onset. This will be achieved through analysis of polymorphisms in the selected genes in TMD patients (DC/TMD) and matched control subjects. The possibility of involvement of specific polymorphisms in modulation of therapy response will also be investigated. The hypotheses: (I) the Single Nucleotide Polymorphism (SNPs) clustering will be dependent on presence or absence of TMD (comparison of patients with control subjects), and will possibly depend on source of pain, pain intensity, presence of bone changes, psychological features and previous orthodontic therapy, and (II) SNPs will influence the treatment response. Along with anamnestic and clinical examination and occlusal splint therapy, genomic DNA will be analyzed from the buccal swabs. Isolated DNA will be used for the determination of 19 polymorphisms of selected genes using Real-Time PCR method. The analysis of salivary oxidative stress markers and opiorphin will be also performed, as their relationship with TMD has been shown previously. This time, their concentration will be associated with polymorphisms in the promoters of genes responsible for their synthesis. The investigators expect to show that particular gene profile or group of SNPs represent a risk factor for TMD development. Innovative approach of the concept of determining the genetic predisposition for TMD has the potential for development of commercial genetic test with potential for risk estimation in relation to TMD onset. This could enable early interventions and active avoidance of environmental risk factors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
    • N/A = Not Applicable
      • Zagreb, N/A = Not Applicable, Croatia, 10000
        • Recruiting
        • School of Dental Medicine, University of Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include subjects, 15 years and older, with a report of ongoing for a duration of >3 months and diagnosis of TMD according DC/TMD and age matched control subjects

Description

Inclusion Criteria:

  • diagnosis of myofascial pain / arthralgia / painful disc displacement according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
  • average pain in the last 10 days >30 mm on a Visual Analogue Scale
  • pain duration of at least 3 months
  • good oral hygiene
  • presence of own natural teeth
  • absence of any form of chronic pain in the orofacial region or in other regions of the body

Exclusion Criteria:

  • other orofacial pain conditions including dental pain
  • poor oral hygiene, gingivitis or periodontitis
  • chronic medical conditions (diabetes, cardiovascular diseases, cancer, and autoimmune diseases) - - -
  • neurological and psychiatric disorders
  • pregnancy
  • causes of headache, unrelated to TMD, listed in the International Classification of Headache Disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
patients with temporomandibular disorders
Device: stabilization splint
The device made of a hard acrylic on stone cast of the upper jaw in the centric relation position. It has a thickness of 1.5 mm at the level of the first molar.
Procedure: physical therapy
Home-exercise program included exercises for passive and active stretching, joint mobilization, passive extension, and translational movements to the right, left, and forward.
Device: placebo splint
The placebo splint was made of thin heat-treatable foil (0.5 mm). The foil was heated and printed over a plaster model of the upper jaw resulting in a very thin film over the occlusal surfaces of all teeth.
group 2
healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline characteristic pain intensity at 6 months
Time Frame: baseline, 6th month

The characteristic pain intensity (part of Graded Chronic Pain Scale, GCPS) compute mean of items (pain right now, worst pain, average pain), and multiply by 10.

Each item ranges from 0 to 10, with higher scores mean a worse outcome.
baseline, 6th month
change from baseline spontaneous pain at 6 months
Time Frame: baseline, 6th month
For evaluation of spontaneous pain from the temporomandibular joint and the masticatory muscles a 100 mm horizontal Visual analogue scale (VAS) is used. Visual analogue scale ranges from 0 to 100, with higher scores mean a worse outcome.
baseline, 6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline range of mouth opening at 6 months
Time Frame: baseline, 6th month
  1. The pain-free opening is defined as the maximum amount that a patient achieves by opening the mouth without feeling pain and is measured as the distance between the incisal edges of the upper and lower central incisors.
  2. Maximum unassisted mouth opening is measured as the distance between the maxillary and mandibular central incisors and defined as the largest amount of opening that a patient can achieve regardless of pain and discomfort.
baseline, 6th month
change from baseline anxiety at 6 months
Time Frame: baseline, 6th month
the General anxiety disorder questionnaire (GAD-7) (a 7-question questionnaire that assesses the severity of respondents' anxiety symptoms) is used for assessing the severity of anxiety symptoms of the participants. Scale ranges fro 0 to 21, with higher scores mean a worse outcome. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.
baseline, 6th month
change from baseline depression at 6 months
Time Frame: baseline, 6th month
The Patient Health Questionnaire-9 (PHQ-9) is used for measuring the severity of depressive symptoms. Scores range from 0 to 27, with cut-points 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression, respectively.
baseline, 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Croatian Science Foundation

Investigators

  • Principal Investigator: Iva Z Alajbeg, School of Dental Medicine, University of Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 30, 2025

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 1, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-2019-04-6211

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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