Xerostomia Dry mouth Early immature durian Oral moisture Saliva substitutes Quality of life Xerostomia
Conditions
Interventions
2.5% early immature durian solution will be filled in amber, unlabeled 30 mL bottles and administered as two pumps of the spray (approximately 0.25 mL) four times daily for 2 weeks,The solution will b
Experimental Drug,Placebo Comparator No treatment
2.5% early immature durian spray,Placebo spray
Sponsors
Faculty of dentistry, Chulalongkorn University
The Royal College of Dental Surgeons of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who reported experiencing oral dryness for more than 3 months, with a VAS score of 30 mm or greater 2. Age 18 years or older 3. Capable of understanding and communicating in Thai
Exclusion criteria
Exclusion criteria: 1. Heavy smokers (more than 25 cigarettes/day) 2. High risk alcohol consumption (more than 60 g/day for men, 40 g/day for women) 3. Patients with burning sensation in the mouth not related to oral dryness 4. Patients using pharmacological saliva stimulants (e.g. pilocarpine, cevimeline) 5. Patients with oral ulcerations at the beginning of study period 6. Patients with active oral infection (e.g., oral candidiasis) at the beginning of study period 7. Patients currently receiving systemic chemotherapy or head-and-neck radiotherapy, or who completed either treatment less than 3 months 8. Patients documented allergies to durian, alcohol derivatives, propanediol, cosmetic products containing propanediol or paraben 9. Patients who decline to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective oral dryness severity At 2 weeks after the end of each intervention VAS (mm),Xerostomia related quality of life At 2 weeks after the end of each intervention Thai version of XeQoLS (score 0 to 60) | — |
Secondary
| Measure | Time frame |
|---|---|
| Unstimulated salivary flow rate At 2 weeks after the end of each intervention Clinical examination by researcher (mL/min),Stimulated salivary flow rate At 2 weeks after the end of each intervention Clinical examination by researcher (mL/min),Salivary pH At 2 weeks after the end of each intervention Clinical examination by researcher (pH),The Clinical Oral Dryness Score (CODS) At 2 weeks after the end of each intervention Clinical examination by researcher (score 0-10),Adverse effects assessment At 2 weeks after the end of each intervention Patient reported outcome using a questionnaire interview,Satisfaction assessment At 2 weeks after the end of each intervention Patient reported outcome using a questionnaire interview (NRS 0-10) | — |
Countries
Thailand
Contacts
Public ContactPawitra Kanjanapaisit
Chulalongkorn university
Outcome results
None listed