Genetic Polymorphisms and Their Association With Temporomandibular Disorders

NCT ID: NCT04694274

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Disorders Orofacial Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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group 1

patients with temporomandibular disorders

stabilization splint

Intervention Type DEVICE

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.

physical therapy

Intervention Type PROCEDURE

Home-exercise program included exercises for passive and active stretching, joint mobilization, passive extension, and translational movements to the right, left, and forward.

placebo splint

Intervention Type DEVICE

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Croatian Science Foundation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Iva Alajbeg

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iva Z Alajbeg

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Zagreb

Locations

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School of Dental Medicine, University of Zagreb

Zagreb, N/A = Not Applicable, Croatia

Site Status RECRUITING

Countries

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Croatia

Central Contacts

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Iva Z Alajbeg, PhD

Role: CONTACT

0038514802125

Ivan Alajbeg, PhD

Role: CONTACT

0038514802124

Facility Contacts

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Iva Z Alajbeg, PhD

Role: primary

00385917930164

References

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Alajbeg IZ, Lapic I, Rogic D, Vuletic L, Andabak Rogulj A, Illes D, Knezovic Zlataric D, Badel T, Vrbanovic E, Alajbeg I. Within-Subject Reliability and between-Subject Variability of Oxidative Stress Markers in Saliva of Healthy Subjects: A Longitudinal Pilot Study. Dis Markers. 2017;2017:2697464. doi: 10.1155/2017/2697464. Epub 2017 Nov 15.

Reference Type BACKGROUND
PMID: 29269980 (View on PubMed)

Vrbanovic E, Alajbeg IZ. Long-term Effectiveness of Occlusal Splint Therapy Compared to Placebo in Patients with Chronic Temporomandibular Disorders. Acta Stomatol Croat. 2019 Sep;53(3):195-206. doi: 10.15644/asc53/3/1.

Reference Type BACKGROUND
PMID: 31749451 (View on PubMed)

Vrbanovic E, Lapic I, Rogic D, Alajbeg IZ. Changes in salivary oxidative status, salivary cortisol, and clinical symptoms in female patients with temporomandibular disorders during occlusal splint therapy: a 3-month follow up. BMC Oral Health. 2019 Jun 6;19(1):100. doi: 10.1186/s12903-019-0791-8.

Reference Type BACKGROUND
PMID: 31170954 (View on PubMed)

Vrbanovic E, Alajbeg IZ, Vuletic L, Lapic I, Rogic D, Andabak Rogulj A, Illes D, Knezovic Zlataric D, Badel T, Alajbeg I. Salivary Oxidant/Antioxidant Status in Chronic Temporomandibular Disorders Is Dependent on Source and Intensity of Pain - A Pilot Study. Front Physiol. 2018 Oct 17;9:1405. doi: 10.3389/fphys.2018.01405. eCollection 2018.

Reference Type BACKGROUND
PMID: 30386251 (View on PubMed)

Alajbeg IZ, Gikic M, Valentic-Peruzovic M. Mandibular Range of Movement and Pain Intensity in Patients with Anterior Disc Displacement without Reduction. Acta Stomatol Croat. 2015 Jun;49(2):119-27. doi: 10.15644/asc49/2/5.

Reference Type BACKGROUND
PMID: 27688394 (View on PubMed)

Alajbeg IZ, Vrbanovic E, Lapic I, Alajbeg I, Vuletic L. Effect of occlusal splint on oxidative stress markers and psychological aspects of chronic temporomandibular pain: a randomized controlled trial. Sci Rep. 2020 Jul 3;10(1):10981. doi: 10.1038/s41598-020-67383-x.

Reference Type RESULT
PMID: 32620810 (View on PubMed)

Vrbanovic E, Alajbeg IZ, Alajbeg I. COVID-19 pandemic and Zagreb earthquakes as stressors in patients with temporomandibular disorders. Oral Dis. 2021 Apr;27 Suppl 3(Suppl 3):688-693. doi: 10.1111/odi.13488. Epub 2020 Jul 13.

Reference Type RESULT
PMID: 32533874 (View on PubMed)

Alajbeg IZ, Vrbanovic E, Alajbeg I, Orabovic I, Naka K, Mrla A, Boucher Y. Time-course of pain and salivary opiorphin release in response to oral capsaicin differ in burning mouth syndrome patients, temporomandibular disorders patients and control subjects. Clin Oral Investig. 2024 Apr 9;28(5):246. doi: 10.1007/s00784-024-05653-y.

Reference Type DERIVED
PMID: 38589630 (View on PubMed)

Vrbanovic E, Zlendic M, Alajbeg IZ. Association of oral behaviours' frequency with psychological profile, somatosensory amplification, presence of pain and self-reported pain intensity. Acta Odontol Scand. 2022 Oct;80(7):522-528. doi: 10.1080/00016357.2022.2042380. Epub 2022 Mar 7.

Reference Type DERIVED
PMID: 35254961 (View on PubMed)

Gikic M, Vrbanovic E, Zlendic M, Alajbeg IZ. Treatment responses in chronic temporomandibular patients depending on the treatment modalities and frequency of parafunctional behaviour. J Oral Rehabil. 2021 Jul;48(7):785-797. doi: 10.1111/joor.13173. Epub 2021 Apr 12.

Reference Type DERIVED
PMID: 33797785 (View on PubMed)

Other Identifiers

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IP-2019-04-6211

Identifier Type: -

Identifier Source: org_study_id

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