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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	3211
Sponsor	Damascus University
Funder	Damascus University

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Shahed Kuraitby
Principal investigator

Damascus University
Mazzeh Street
Damascus
-
Syria

ORCID ID	0009-0009-1340-9255
Phone	+963 932178578
Email	shahed.kuraitby@damascusuniversity.edu.sy

Dr Shahed Kuraitby
Scientific

Damascus University
Mazzeh Street
Damascus
-
Syria

Phone	+963 932178578
Email	shahed.y1997@gmail.com

Prof Abeer Aljoujou
Public

Head of Department of oral medicine
faculty of dentistry
Damascus university
Kafarsousa Street
Damascus
-
Syria

Phone	+963944703131
Email	abeerjoujou@gmail.com

Study information

Primary study design	Interventional
Study design	Randomized controlled clinical study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Curcumin suspension, nystatin suspension
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
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	All
Target sample size at registration	30
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

Department of Oral Medicine at the Faculty of Dentistry at Damascus University

Mazzeh Street
Damascus
-
Syria

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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).