Genetic Polymorphisms and Their Association With Temporomandibular Disorders
NCT ID: NCT04694274
Last Updated: 2021-01-06
Study Results
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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UNKNOWN
60 participants
OBSERVATIONAL
2017-05-01
2025-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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group 1
patients with temporomandibular disorders
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.
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.
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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
59 Years
ALL
Yes
Sponsors
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Croatian Science Foundation
OTHER_GOV
Responsible Party
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Iva Alajbeg
Prof
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IP-2019-04-6211
Identifier Type: -
Identifier Source: org_study_id
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