Oral Health, Saliva Viscosity and Composition in Oculo-Pharyngeal Muscular Dystrophy (OPMD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oculopharyngeal Muscular Dystrophy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Saliva Composition in Oculo-Pharyngeal Muscular Dystrophy (OPMD)
Overview
The goal of this observational study is to explore whether oral health and saliva viscosity and composition in Oculopharyngeal Muscular Dystrophy (OPMD) is different from control subjects. 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?
Detailed description
The objectives of this observational study is to investigate oral health, saliva rheology and explore biochemical markers in OPMD. specifically to determine if anecdotal reports of "thick saliva" represent a previously unrecognized manifestation of the disease.
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.
Primary outcome measures
- Saliva Viscosity [Time frame: Upon enrollment in the study]
Secondary outcome measures (1)
- Oral health indices [Time frame: Upon enrollment in the study]
Eligibility criteria
Inclusion criteria
- Patients with OPMD and their spouses or household members
Exclusion criteria
- • Pregnancy or presence of any disease that may affect a composition of saliva
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Family-based
Study locations
Israel · 1 center
- Sheba Medical Center — Ramat Gan
Identifiers
NCT: NCT07118280 · SHEBA-22-9824-AZ-CTIL