Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Study Overview
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Brief Summary
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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.

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

Conditions
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Xerostomia

Intervention / Treatment
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* Drug: Pilocarpine
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.1% pilocarpine mouthwash<br>0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline | Drug: Pilocarpine<br>* 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.<br>|
| Placebo Comparator: 0.9% saline mouthwash<br>0.9% saline as a mouthwash | Drug: saline<br>* 0.9% saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerostomia, pilocarpine mouthwash, minor salivary gland secretion