Oral Health, Saliva Viscosity and Composition in Oculo-Pharyngeal Muscular Dystrophy (OPMD)

Recruiting

• Conditions: Oculopharyngeal Muscular Dystrophy

• Registration Number: NCT07118280
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Study Timeline

• Study Start: 2023-03-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2027-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DMFT	Upon enrollment in the study	Total score of decayed, missing and filled teeth (DMFT index)
Saliva Viscosity	Upon enrollment in the study	Viscosity of unstimulated whole saliva

Secondary Outcome Measures

Name	Time	Method
Saliva Metabolomics	Upon enrollment in the study	Metabolomic analysis of unstimulated whole saliva

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel