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A randomized clinical trial on the antimicrobial activity and safety of 0.5% chitosan mouth spray

A randomized clinical trial on the antimicrobial activity and safety of 0.5% chitosan mouth spray

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221129002
Enrollment
60
Registered
2022-11-29
Start date
2022-12-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy with ASA (American association of Anesthesiologists) class 1 and class 2 0.5% Chitosan, Mouth spray, Antimicrobial activity, Safety

Interventions

Mouth spray with 0.5% Chitosan ,Mouth spray without Chitosan ,0.12% Chlorhexidine gluconate (Mybacin)
0.5% Chitosan mouth spray ,Mouth spray without Chitosan ,Chlorhexidine mouth spray

Sponsors

Faculty of Dentistry, Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. ASA (American association of Anesthesiologists) class 1 and class 2 2. at least 10 teeth in the mouth

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Antimicrobial activity at baseline, day 1 and day 14 end of the intervention Microbial culture

Secondary

MeasureTime frame
Safety at baseline, day 1 and day 14 end of the intervention Clinical assessment, sialometry and questionnaire

Countries

Thailand

Contacts

Public ContactWilairat Sarideechaigul

Faculty of Dentistry, Khon Kaen University

wilairat@kku.ac.th0816613325

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026