Comparison effect of anti fungal therapy with curcumin and nystatin in denture stomatitis in Islamic Azad University of Tehran- school of Dentistry
Design
Randomized clinical trial, parallel group, single blind, without placebo
Settings and conduct
in patients who refer to Oral Medicine department of school of Dentistry-Islamic Azad University of Tehran who have type 2 and 3 denture stomatitis first erythema and colony forming unit (CFU) of Candida albicans of patient palate are recorded before treatment. Then patients are randomly divided into two groups of 16 : one group is given nystatin and curcumin, and the other group is given nystatin, and after treatment, erythema and CFU Candida albicans are re-registered..
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients above 18; with Denture stomatitis; type 2 and 3
Exclusion criteria: patients with allergy to curcumin ; pregnant ;breast feeding women; changes in immune system; chemotherapy; radiotherapy; patients who take antibiotics and anti fungal drugs within 4 weeks ago
Intervention groups
Intervention group: The effective ingredient of curcumin in aqueous solvent prepared orally
Control group: Nystatin suspension 100,000 units per milliliter of Emad Company
Main outcome variables
Comparison of treatment result in 2 groups - Decreased number of candida albicans and decreased erythema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200519047516N1
Registration date:2020-07-24, 1399/05/03
Registration timing:prospective
Last update:2020-07-24, 1399/05/03
Update count:0
Registration date
2020-07-24, 1399/05/03
Registrant information
Name
Haniye Meftahpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 9044
Email address
haniye.meftahpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of antifungal effect of Curcumin and Nystatin in denture stomatitis type 2 and type 3
Public title
Comparison of the antifungal effect of Curcumin and Nystatin in treatment of fungous associated with removable prothesis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 18
With denture stomatitis; type 2 and 3
Exclusion criteria:
Exclusion criteria: patients with allergy to curcumin
pregnant
breast feeding women
changes in immune system
chemotherapy
radiotherapy
patients who take antibiotics and anti fungal drugs within 4 weeks ago
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will have two types of denture stomatitis 2 and 3, and to prevent the accumulation of a type of denturestomatitis in a group and its negative impact on the results, the Stratified block randomized method will be used and 32 envelopes are numbered by statistical consultant and the interventions are given to the patients without the knowledge of the researcher of the contents of the envelopes containing the therapeutic intervention and the researcher will not be aware of the contents of the envelope and the intervention made for each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after informing the patient of the type of study, and filling out the drug consent form with the help of another person other than the researcher and according to the random numbers determined by the statistical consultant (2 series No. 1 to 16 for Dentuer Stomatitis Type 2 and 3) It will be given to patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IslamicEthic committe of Islamic Azad university - Dental branch Tehran - Iran
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.007
Health conditions studied
1
Description of health condition studied
Denture stomatitis
ICD-10 code
B37
ICD-10 code description
Candidiasis
Primary outcomes
1
Description
Count of cloni
Timepoint
Before intervention-2 weeks after intervention
Method of measurement
Colony forming unit (CFU) with microbiological measurment
2
Description
Erythema
Timepoint
Before intervention-2 weeks after intervention
Method of measurement
mm2- measured in photoshop program
Secondary outcomes
1
Description
Erythema
Timepoint
before intervention
Method of measurement
Measurement in millimeters
2
Description
Number of Candida albicans colonies
Timepoint
before intervention
Method of measurement
Prepare culture from the patient's mouth and count the number of colonies
Intervention groups
1
Description
Intervention group: drug(Curcumin drops prepared from the active ingredient of curcumin in the pharmacology department of the Faculty of Pharmacy, Islamic Azad University-5 cc -4 times in day for 2 weeks- wash the mouth)
Category
Treatment - Drugs
2
Description
Control group: standard drug(Nyststin suspension100000 unit/ml emad company- 40 drops-4 times in day for 2 weeks- wash the mouth )
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad Islamic University of Tehran-school of Dentistry-Oral Medicine department
Full name of responsible person
Haniye Meftahpour(Oral Medicine assistant)
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4577
Email
haniye.meftahpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Pofessor: Dr Arash Azizi
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4577
Email
siminlesan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Haniye Meftahpour
Position
Doctor Dentist Surgon/ assistant of Oral Medicin
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 33, West 25 Ave., Azadegan Blvd., kordestan highway., Tehran
City
Tehran
Province
Tehran
Postal code
1437714651
Phone
+98 21 8863 9044
Fax
Email
haniye.meftahpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Simin Lesan
Position
Assistant Professor of Oral Medicine
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
siminlesan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Haniye Meftahpour
Position
Doctor Dentist Surgon/ assistant of Oral Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
10th Neyestan- Pasdaran avenue- Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
haniye.meftahpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available