Genetic Polymorphisms and Their Association With Temporomandibular Disorders (GenPolTMD)
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ClinicalTrials.gov Identifier: NCT04694274 |
Recruitment Status :
Recruiting
First Posted : January 5, 2021
Last Update Posted : January 6, 2021
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Condition or disease | Intervention/treatment |
---|---|
Temporomandibular Disorders Orofacial Pain | Device: stabilization splint Procedure: physical therapy Device: placebo splint |
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Genetic Polymorphisms and Their Association With Temporomandibular Disorders |
Actual Study Start Date : | May 1, 2017 |
Estimated Primary Completion Date : | January 30, 2024 |
Estimated Study Completion Date : | January 30, 2025 |
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
|
- 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.
- 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.
- change from baseline range of mouth opening at 6 months [ Time Frame: baseline, 6th month ]
- 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.
- 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.
- 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.
- 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.
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Ages Eligible for Study: | 15 Years to 59 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04694274
Contact: Iva Z Alajbeg, PhD | 0038514802125 | ialajbeg@sfzg.hr | |
Contact: Ivan Alajbeg, PhD | 0038514802124 | ialajbeg@sfzg.hr |
Croatia | |
School of Dental Medicine, University of Zagreb | Recruiting |
Zagreb, N/A = Not Applicable, Croatia, 10000 | |
Contact: Iva Z Alajbeg, PhD 00385917930164 ialajbeg@sfzg.hr |
Principal Investigator: | Iva Z Alajbeg | School of Dental Medicine, University of Zagreb |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Iva Alajbeg, Prof, University of Zagreb |
ClinicalTrials.gov Identifier: | NCT04694274 |
Other Study ID Numbers: |
IP-2019-04-6211 |
First Posted: | January 5, 2021 Key Record Dates |
Last Update Posted: | January 6, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Facial Pain Craniomandibular Disorders Mandibular Diseases Jaw Diseases Musculoskeletal Diseases |
Joint Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Pain Neurologic Manifestations |