Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Not Applicable

Completed

• Conditions: Xerostomia
• Interventions: Drug: saline; Drug: Pilocarpine

• Registration Number: NCT01627626
• Lead Sponsor: Jeong-seong Kwon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-10
• Study Completion: 2012-03
• Status Verified: 2012-06
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-21
• Last Update Submitted: 2012-06-21
• Study First Posted: 2012-06-26
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% saline mouthwash	saline	0.9% saline as a mouthwash
0.1% pilocarpine mouthwash	Pilocarpine	0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Yonsei University Dental Hospital; 🇰🇷 Seoul, Korea, Republic of