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ocal Application of Pilocarpine for Relieving Dry Mouth Complaints: A randomized controlled pilot trial

Phase 2
Completed
Conditions
mond, keelholte
dry mouth
xerostomia
Registration Number
NL-OMON48076
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

• >= 70 years of age;• Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score >= 5 (scale 0 - 10, with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months.

Exclusion Criteria

• Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician ;• Inability to fill out the questionnaires due to other reasons;• Prior radiation therapy of the head-and-neck region;• Known m. Sjögren disease;• Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Change in xerostomia score<br /><br>Change in oral health-related quality of life </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Adverse effects<br /><br>- Other symptoms<br /><br>- Global perceived effect</p><br>
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