A comparative study between the antifungal activity of curcumin and nystatin in denture stomatitis (randomized controlled trial)
| ISRCTN | ISRCTN15898291 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15898291 |
| Secondary identifying numbers | 3211 |
- Submission date
- 07/08/2023
- Registration date
- 24/08/2023
- Last edited
- 02/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Denture stomatitis is an inflammation of the oral mucosa caused by Candida infections. This study will compare the effectiveness of curcumin suspension and nystatin suspension in patients for the treatment of denture stomatitis.
Who can participate?
Patients who have been diagnosed with denture stomatitis
What does the study involve?
The patients will be randomly assigned to one of two groups:
Group I: The patients in this group will be treated with curcumin suspension three times a day for 14 days
Group II: The patients in this group will be treated with nystatin suspension three times a day for 14 days
The effectiveness of the two treatments will be assessed by three measures:
1. Healing: The patients' oral mucosa will be evaluated using a scale of oral mucositis at 7 and 14 days after treatment
2. Taste acceptability: The patients will be asked to rate the taste of the two treatments on a hedonic scale on the 14th day after treatment
3. Laboratory assessment: The number of fungal colonies will be counted before and after treatment
What are the possible benefits and risks of participating?
This study will increase the trend towards the use of natural materials to reduce the drug interactions of traditional antifungal drugs. The curcumin plant has been chosen because of its ease of availability and its scientifically proven antifungal properties in many studies.
This study will provide valuable information on the effectiveness of curcumin suspension and nystatin suspension in the treatment of denture stomatitis. The results of this study could lead to the development of new and more effective treatments for this condition.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
Match 2022 to March 2024
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Shahed Kuraitby, shahed.kuraitby@damascusuniversity.edu.sy (Syria)
Contact information
Principal Investigator
Damascus University
Mazzeh Street
Damascus
-
Syria
 ORCID ID |
0009-0009-1340-9255 |
|---|---|
| Phone | +963 932178578 |
| shahed.kuraitby@damascusuniversity.edu.sy |
Scientific
Damascus University
Mazzeh Street
Damascus
-
Syria
| Phone | +963 932178578 |
|---|---|
| shahed.y1997@gmail.com |
Public
Head of Department of oral medicine
faculty of dentistry
Damascus university
Kafarsousa Street
Damascus
-
Syria
| Phone | +963944703131 |
|---|---|
| abeerjoujou@gmail.com |
Study information
| Study design | Randomized controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, Laboratory |
| Study type | Treatment, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | In patients with denture stomatitis, is there evidence to suggest that curcumin gives better clinical and laboratory antifungal results than nystatin? |
| Study objectives | 1. Does curcumin suspension have efficacy in treating denture stomatitis? 2. Does curcumin suspension outperform traditional fungal drugs? 3. Does curcumin suspension affect the number of fungal colonies? |
| Ethics approval(s) |
Approved 24/07/2022, Scientific Research Council at the Faculty of Dentistry at Damascus University (Mazzeh Street, Damascus city, -, Syria; +963112119809; dl.srd@damascusuniversity.edu.sy), ref: 3211 |
| Health condition(s) or problem(s) studied | Denture stomatitis |
| Intervention | Patients who are informally and clinically positive for denture stomatitis will be enrolled in this study. The patients were divided into two groups: Group I: Curcumin suspension three times a day, 15 ml per dose, for 14 days Group II: Nystatin suspension 100,000 UN three times a day for 14 days The patients were assigned to the two groups in a sequential manner, with the first patient receiving treatment with curcumin suspension, the second patient receiving treatment with nystatin suspension, and so on. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Curcumin suspension, nystatin suspension |
| Primary outcome measure | 1. Healing measured using a scale of oral mucositis at 7 and 14 days 2. Taste acceptability measured using a Hedonic scale on the day 14 since treatment began |
| Secondary outcome measures | Laboratory assessment measured using the decrease in the number of fungal colonies taken before the commencement of processing and on day 14 after the completion of processing |
| Overall study start date | 26/03/2022 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Patient, Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 30 patients divided into two groups so that each group includes 15 patient |
| Key inclusion criteria | 1. Adult patients 2. Male or female 3. Who use dental devices 4. Clinically and informally diagnosed with denture stomatitis |
| Key exclusion criteria | 1. Pregnant or nursing women 2. Patients treated with any antifungal medication over the past two weeks 3. Patients with any allergic reactions to studied substances 4. Patients with HIV 5. Immunosuppressed patients |
| Date of first enrolment | 03/10/2022 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Scientific Research Council
Mazzeh Street
Damascus
-
Syria
| Phone | +96301133923401 |
|---|---|
| ep.srd@damascusuniversity.edu.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and analyzed during the current study will be available on request from Shahed kuraitby (shahed.kuraitby@damascusuniversity.edu.sy) |
Editorial Notes
02/10/2023: The principal investigator's details have been updated.
25/08/2023: The public title was changed from "A comparative study between the antifungal activity of curcumin and nystatin in denture stomatitis" to "A comparative study between the antifungal activity of curcumin and nystatin in denture stomatitis (randomized controlled trial)".
15/08/2023: Trial's existence confirmed by the Scientific Research Council at the Faculty of Dentistry at Damascus University (Syria).
