Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

NCT01627626 | Completed

• 1 other identifier: 2-2011-0032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia

Keywords

xerostomia; pilocarpine mouthwash; minor salivary gland secretion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes)

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

  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

  4 weeks

Study Arms (2)

0.1% pilocarpine mouthwash

EXPERIMENTAL

0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline

Drug: Pilocarpine

0.9% saline mouthwash

PLACEBO COMPARATOR

0.9% saline as a mouthwash

Drug: saline

Interventions

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.

0.1% pilocarpine mouthwash

saline DRUG

0.9% saline solution

0.9% saline mouthwash

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• xerostomia for 3 months or more, and
• adults aged 20 years and older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeong-seong Kwon: lead

Study Sites (1)

Yonsei University Dental Hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Pilocarpine; Sodium Chloride

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jeong-Seung Kwon, DDS,MSD,PhD

  Yonsei University Dental Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 26, 2012
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

KR (1)