Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

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

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia
• Intervention / Treatment: Drug: Pilocarpine; Drug: saline

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.1% pilocarpine mouthwash; 0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline	Drug: Pilocarpine; 0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline. subjects were instructed to mouthwash with 10ml of solution for 1 minute.
Placebo Comparator: 0.9% saline mouthwash; 0.9% saline as a mouthwash	Drug: saline; 0.9% saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in minor salivary flow rates at 60 minutes	Minor salivary flow rates (from buccal, lower labial and palatal mucosa) were measured before and after using the mouthwash at predetermined times: baseline, immediately (0 min), and 30 and 60 minutes after. The Periotron 8000 device (Oraflow, New York, USA)was used to measure the flow rate (µl/cm2 per min) of saliva from the minor glands, in accordance with the method of Eliasson et al. (1996).	before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the severity of oral dryness at 60 minutes	The severity of oral dryness was measured on a numerical rating scale (NRS ; 0-10, where 0=no dry mouth and 10=the worst dry mouth imaginable) before and after using the mouthwash at predetermined times: baseline, immediately (0 min), and 30 and 60 minutes after.	Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Change from baseline in the unstimulated whole salivary flow rates at 60 minutes	Unstimulated whole salivary flow rates (ml/min) were measured before and after using the mouthwash at predetermined times: baseline, and 60 minutes after. Unstimulated whole saliva was collected via the spitting method for 10 minutes while the subject was sitting in an upright position with the head slightly tilted forward and the eyes open after resting for 5 minutes. Subjects were instructed to minimize their orofacial movements during measurement.	Before and after using mouthwash (baseline, 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	The severity of oral dryness, minor salivary flow rates, and the unstimulated whole salivary flow rates were measured after using the prescribed mouthwash regularly (with 10 ml of the solution for 1 minute, three times per day) for 4 weeks.	4 weeks

Collaborators and Investigators

• Sponsor: Jeong-seong Kwon
• Investigators: Principal Investigator: Jeong-Seung Kwon, DDS,MSD,PhD, Yonsei University Dental Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: xerostomia; pilocarpine mouthwash; minor salivary gland secretion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Miotics; Muscarinic Agonists; Pilocarpine
• Other Study ID Numbers: 2-2011-0032