Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeong-seong Kwon, Yonsei University
ClinicalTrials.gov Identifier:
NCT01627626
First received: June 13, 2012
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Xerostomia
Drug: Pilocarpine
Drug: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Change from baseline in minor salivary flow rates at 60 minutes [ Time Frame: before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before and after using mouthwash (baseline, 60 minutes) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627626

Locations
Korea, Republic of
Yonsei University Dental Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Jeong-seong Kwon
Investigators
Principal Investigator: Jeong-Seung Kwon, DDS,MSD,PhD Yonsei University Dental Hospital
  More Information

No publications provided

Responsible Party: Jeong-seong Kwon, Clinical assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01627626     History of Changes
Other Study ID Numbers: 2-2011-0032
Study First Received: June 13, 2012
Last Updated: June 21, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
xerostomia
pilocarpine mouthwash
minor salivary gland secretion

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014