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Effectiveness of a novel alcohol free chitosan-curcumin mouthwash in management of oral lesions and evaluation of factors related to recurrent denture stomatitis

Efficacy of nonirritant chitosan-curcumin mouthwash in treating denture stomatitis: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171114001
Enrollment
Unknown
Registered
2017-11-14
Start date
2016-08-01
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

The word stomatitis means inflammation of oral mucosa. Denture stomatitis (DS) thus indicates inflammation of oral mucosa under the denture. Lesions of DS are more frequently found in the upper jaw&#44

Interventions

Alcohol free chitosan&#45
curcumin mouthwash based on PEG 400 and water as cosolvent&#44
containing 0.1% curcumin was prepared. Each time a 10 mL of freshly prepared chitosan&#45
curcumin mouthwash was given to patient for mouthwash for 30 sec three times a day at 8 am&#44
12 pm and 4 pm for two weeks.,Formulation with chitosan (0.5%) but without curcumin was used. 10 mL of chlorhexidine mouthwash solution was given each time for mouthwash for 30 sec three times a day a
12 pm and 4 pm for two weeks., 20% chlorhexidine stock solution was diluted to 0.2% to be used by patient. 10 mL of chlorhexidine mouthwash solution was given each time for mouthwash for 30 sec three
12 pm and 4 pm for two weeks.
0.1% Chitosan&#45
curcumin moutwash,0.1% Chitosan moutwash,0.2% Chlorhexidine mouthwah

Sponsors

Department of Clinical Pharmacy
Lead Sponsor
Department of Stomatology
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 20 years of age and older 2. Confirm of denture stomatitis by the oral medicine specialists 3. Able to use mouthwash correctly

Exclusion criteria

Exclusion criteria: 1. Patients with open mouth sores at study entry. 2. Patients with HIV infections, diabetes mellitus, or hyperthyroidism. 3. Patients using any other prophylactic mouthwashes within last month. 4. Patients who required use of any form of treatment/medicaments (e.g., antibiotics, analgesics, etc.) during the course of study. 5. Patients who had received any recent treatment with antifungal, antibacterial, chemotherapeutic and immunosuppressive agents within last month 6. Pregnant woman 7. Patients who are allergic to chitosan-curcumin mouthwash or chlorhexidine solution 8. Patients with mouth ulcers from other causes eg. trauma, aphthous ulcer at study entry

Design outcomes

Primary

MeasureTime frame
Complete relief of erythematous lesions or reduction of diameter of erythematous lesion under dentur prior intervention, 2 weeks after inervention Site activity score from challacomb scale was used to evaluate and grade the lesions under denture,Reduction in number of colonies of Candida present in oral cavity of the patients. prior intervention, after intervention 2 week, Oral rinse method was used to collect C. albicans, culture for fungus and count for number

Secondary

MeasureTime frame
Reduction in number of colonies of Candida present in oral cavity of the patients prior intervention, after intervention 2 week Oral swab and oral rinse method was used to collect C. albicans, culture for fungus and count for nu

Countries

Thailand

Contacts

Public ContactKanokporn Pangsomboon

Department of Pharmaceutical Technology

kanokporn.p@psu.ac.th087-63302525

Outcome results

None listed

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