Effect of 0.1% Pilocarpine Mouthwash on Xerostomia

Jeong-seong Kwon

Status: Completed

Conditions: Xerostomia

Treatments: Drug: saline; Drug: Pilocarpine

Study type: Interventional

Funder types: Other

Identifiers

NCT01627626

2-2011-0032

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

0.1% pilocarpine mouthwash

Experimental group

Description:

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

Treatment:

Drug: Pilocarpine

0.9% saline mouthwash

Placebo Comparator group

Description:

0.9% saline as a mouthwash

Treatment:

Drug: saline