Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627626
• Other study ID #: 2-2011-0032
• Status: Completed
• Phase: N/A
• First received: June 13, 2012
• Last updated: June 21, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Xerostomia

Intervention

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.
• saline
0.9% saline solution

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Dental Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeong-seong Kwon

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No