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Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Xerostomia

Intervention: Pilocarpine (Drug); saline (Drug)

Phase: N/A

Status: Completed

Sponsored by: Jeong-seong Kwon

Official(s) and/or principal investigator(s):
Jeong-Seung Kwon, DDS,MSD,PhD, Principal Investigator, Affiliation: Yonsei University Dental Hospital

Summary

The aim of this study is to evaluate the effect of 0. 1% pilocarpine mouthwash on subjective dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic patients.

Clinical Details

Official title: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Change from baseline in minor salivary flow rates at 60 minutes

Secondary outcome:

Change from baseline in the severity of oral dryness at 60 minutes

Change from baseline in the unstimulated whole salivary flow rates at 60 minutes

Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- xerostomia for 3 months or more, and

- adults aged 20 years and older.

Exclusion Criteria:

- acute asthma attack

- acute iritis

- narrow angle glaucoma

- pilocarpine allergy

- pregnancy

- lactating women, and

- person who was treating xerostomia with artificial saliva, pilocarpine, or etc.

Locations and Contacts

Yonsei University Dental Hospital, Seoul 120-752, Korea, Republic of
Additional Information

Starting date: August 2011
Last updated: June 21, 2012

Page last updated: August 23, 2015

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