Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Sponsor

Jeong-seong Kwon (Other)

Overall Status

Completed

CT.gov ID

NCT01627626

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia	Drug: Pilocarpine Drug: saline	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in minor salivary flow rates at 60 minutes [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

Change from baseline in the severity of oral dryness at 60 minutes [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.
Change from baseline in the unstimulated whole salivary flow rates at 60 minutes [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.
Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong-seong Kwon, Clinical assistant professor, Yonsei University

ClinicalTrials.gov Identifier:

NCT01627626

Other Study ID Numbers:

2-2011-0032

First Posted:

Jun 26, 2012

Last Update Posted:

Jun 26, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Jeong-seong Kwon, Clinical assistant professor, Yonsei University

xerostomia

pilocarpine mouthwash

minor salivary gland secretion

Additional relevant MeSH terms:

Xerostomia

Pilocarpine

Study Results

No Results Posted as of Jun 26, 2012