A randomized clinical trial on the antimicrobial activity and safety of 0.5% chitosan mouth spray
Phase 1
- Conditions
- Healthy with ASA (American association of Anesthesiologists) class 1 and class 20.5% Chitosan, Mouth spray, Antimicrobial activity, Safety
- Registration Number
- TCTR20221129002
- Lead Sponsor
- Faculty of Dentistry, Khon Kaen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. ASA (American association of Anesthesiologists) class 1 and class 2
2. at least 10 teeth in the mouth
Exclusion Criteria
1. Chitosan allergy
2. Preservatives or flavoring agents for allergy
3. High-risk caries
4. Gingival bleeding index of more than 15%
5. Dental crowns or bridges
6. Pathologic oral lesion
7. Received antibiotics, steroids, or immunosuppressants within the last 3 months
8. Pregnant or breastfeeding
9. Alcohol consumption
10. Smoking, marijuana, or other drugs
11. Listening, speaking, reading, and writing in Thai
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antimicrobial activity at baseline, day 1 and day 14 end of the intervention Microbial culture
- Secondary Outcome Measures
Name Time Method Safety at baseline, day 1 and day 14 end of the intervention Clinical assessment, sialometry and questionnaire