Oral Health, Saliva Viscosity and Composition in Oculo-Pharyngeal Muscular Dystrophy (OPMD)
NCT ID: NCT07118280
Last Updated: 2026-01-27
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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RECRUITING
100 participants
OBSERVATIONAL
2023-03-01
2027-03-31
Brief Summary
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The main questions it aims to answer are:
Do swallowing disturbances in OPMD adversely affect oral health? Is saliva thickness (viscosity) is increased in OPMD? Does saliva in OPMD contains biochemical markers of the disease?
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Detailed Description
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Oculo-pharyngeal muscular dystrophy (OPMD) is a rare, late-onset, hereditary (OMIM 164300) progressive degenerative muscle disease characterized by oro-pharyngeal dysphagia and eyelid ptosis and skeletal muscle weakness.
Oro-pharyngeal dysphagia is associated with impaired oral health in elderly patients in general, in patients with neurodegenerative diseases and in Parkinson's disease. Yet, oral health in OPMD has not been explored so far. Additionally, a notion in one report that more than half of patients with OPMD complained about "having thick saliva" has not triggered further research of saliva properties in OPMD.
OPMD patients enrolled in IsrOPMD registry at the multidisciplinary OPMD service at the Sheba Medical Center will be offered to participate in the study. Unaffected spouse or household member of each patient will be offered to serve as a control. Subjects younger than 18 years of age and those with any condition that may affect a composition of saliva were excluded from this study.
All study subjects will proceed a thorough stomatological examination documenting the number of decayed, missing and filled teeth (DMFT index), dryness of oral mucosa, presence of tongue coating, atrophic papillae, cleft or geographic tongue, gingival inflammation and gross saliva secretion, unstimulated whole saliva flow rate and saliva viscosity. Untargeted metabolomic analysis of the saliva will be performed.
Conditions
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Study Design
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FAMILY_BASED
CROSS_SECTIONAL
Study Groups
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Patients
Patients with OPMD
No interventions assigned to this group
Control
Unaffected spouse or household member without OPMD
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHEBA-22-9824-AZ-CTIL
Identifier Type: -
Identifier Source: org_study_id
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