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NCT Number: NCT01627626

Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

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.

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Key information

Conditions

Xerostomia Mouth Diseases Salivary Gland Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Dental Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilocarpine

Drug

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

Drug

0.9% saline solution

Primary outcomes

  1. Change from baseline in minor salivary flow rates at 60 minutes

    Time frame: 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 outcomes

  1. Change from baseline in the severity of oral dryness at 60 minutes

    Time frame: 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.

  2. Change from baseline in the unstimulated whole salivary flow rates at 60 minutes

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jeong-seong Kwon

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Jun 26, 2012
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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