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Trial record 46 of 580 for:    dry mouth

Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

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ClinicalTrials.gov Identifier: NCT01627626
Recruitment Status : Completed
First Posted : June 26, 2012
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
Jeong-seong Kwon, Yonsei University

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.

Condition or disease Intervention/treatment Phase
Xerostomia Drug: Pilocarpine Drug: saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial
Study Start Date : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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




Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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) ]
    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.

  2. Change from baseline in the unstimulated whole salivary flow rates at 60 minutes [ Time Frame: Before and after using mouthwash (baseline, 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.

  3. 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 ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jeong-seong Kwon, Clinical assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01627626     History of Changes
Other Study ID Numbers: 2-2011-0032
First Posted: June 26, 2012    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Keywords provided by Jeong-seong Kwon, Yonsei University:
xerostomia
pilocarpine mouthwash
minor salivary gland secretion

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