Hyposalivation Hyposalivation, Dry mouth, Pilocarpine, Saliva stimulant
Conditions
Interventions
The solution is filled in a 50 ml bottle spray, and each pump will deliver approximately
0.08 ml of the solution. Participants will be instructed to spray once onto the hard palate and
left and righ
Active Comparator Drug,Placebo Comparator Drug
New formulation of 0.2% pilocarpine spray,Placebo spray
Sponsors
Faculty of dentistry, Chulalongkorn University
The Royal College of Dental Surgeons of Thailand
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Thai patients diagnosed with hyposalivation (unstimulated whole salivary flow less than or equal to 0.1 ml/min) 2. Thai patients with VAS score of oral dryness more than 25 mm 3. Age 20 and above 4. Able to communicate and self-care
Exclusion criteria
Exclusion criteria: 1. Patients who have received head and neck radiotherapy or chemotherapy 2. Hypersensitivity to pilocarpine or any of the ingredients in pilocarpine spray 3. Patients with asthma, narrow-angle glaucoma, iritis or uncontrolled systemic disease 4. Pregnant or lactating women 5. Patients currently being treated with systemic administration of pilocarpine or other systemic sialogogues 6. Heavy smoker (more than or equal to 25 cigarettes a day) 7. Presence of a microbial infection requiring specific antimicrobial treatment 8. Patients with burning mouth sensation due to causes other than dry mouth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unstimulating salivary flow rate at 1 month after end of the intervention Clinical examination by researcher | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS of dryness at 1 month after end of the intervention Patient reported outcome using a questionnaire interview,The Summated Xerostomia Inventory in Thai version at 1 month after end of the intervention Patient reported outcome using a questionnaire interview,The Clinical Oral Dryness Score (CODS) at 1 month after end of the intervention Clinical examination by researcher,Adverse effects assessment at 1 month after end of the intervention Patient reported outcome using a questionnaire interview,Satisfaction assessment at 1 month after end of the intervention Patient reported outcome using a questionnaire interview | — |
Countries
Thailand
Contacts
Public ContactKanokkorn Kijkanjanamongkol
Chulalongkorn University
Outcome results
None listed