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Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Primary Purpose

Xerostomia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pilocarpine
saline
Sponsored by
Jeong-seong Kwon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Xerostomia focused on measuring xerostomia, pilocarpine mouthwash, minor salivary gland secretion

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yonsei University Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

0.1% pilocarpine mouthwash

0.9% saline mouthwash

Arm Description

0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline

0.9% saline as a mouthwash

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 13, 2012
Last Updated
June 21, 2012
Sponsor
Jeong-seong Kwon
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1. Study Identification

Unique Protocol Identification Number
NCT01627626
Brief Title
Effect of 0.1% Pilocarpine Mouthwash on Xerostomia
Official Title
Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeong-seong Kwon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
Keywords
xerostomia, pilocarpine mouthwash, minor salivary gland secretion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.1% pilocarpine mouthwash
Arm Type
Experimental
Arm Description
0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline
Arm Title
0.9% saline mouthwash
Arm Type
Placebo Comparator
Arm Description
0.9% saline as a mouthwash
Intervention Type
Drug
Intervention Name(s)
Pilocarpine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
0.9% saline solution
Primary Outcome Measure Information:
Title
Change from baseline in minor salivary flow rates at 60 minutes
Description
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).
Time Frame
before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Secondary Outcome Measure Information:
Title
Change from baseline in the severity of oral dryness at 60 minutes
Description
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.
Time Frame
Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Title
Change from baseline in the unstimulated whole salivary flow rates at 60 minutes
Description
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.
Time Frame
Before and after using mouthwash (baseline, 60 minutes)
Title
Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Seung Kwon, DDS,MSD,PhD
Organizational Affiliation
Yonsei University Dental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Dental Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

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