Xerostomia
Conditions
Keywords
xerostomia, pilocarpine mouthwash, minor salivary gland secretion
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.
Interventions
DRUGPilocarpine
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.
DRUGsaline
0.9% saline solution
Sponsors
Jeong-seong Kwon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed