Comparison of clinical and microbiological effect of nystatin suspension on denture stomatitis treatment
Design
a clinical trial with a control group, one blind, nonrandomization
Settings and conduct
Patients referred to the Oral Diseases Department of Beheshti University and patients in Tehran nursing homes who use complete denture and maxillary partial and they have type II denture stomatitis and are in accordance with the mentioned input and output criteria after obtaining the consent, they will enter the study.In order to clinically evaluate patients with a cotton swab from the patients' palate before prescribing the drug to determine the number of Candida colonies will be performed.for achieve a criterion for defining the normal amount of Candida colony in the mouth of people without denture stomatitis, sampling of their palate will be done.Patients are given 30 drops of nystatin suspension 4 times a day.The cotton swab is placed in a Falcon tube containing 1% CC normal saline.After vortex, the tube is inoculated with 10 μl of the contents of the tube into Candida chrome agar.The samples will then be sent for culture of the candidate and counting the number of colony units.Patients will be followed up on the 14th day after drug administration and on the 21st and 28th day after drug administration.They will be sampled again with a swab to count the number of colony units and previous steps will be repeated
Participants/Inclusion and exclusion criteria
Denture stomatitis type II based on Newton classification(؛)Patients diagnosed with diabetes, anemia, immunosuppression, cancer treatment (radiotherapy and chemotherapy)
Intervention groups
achieve a safer duration of recovery (clinical and microbiological) for the treatment of denture stomatitis and the effectiveness of nystatin suspension
Main outcome variables
candida count;candida albicans count;remission time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201028049173N1
Registration date:2020-12-02, 1399/09/12
Registration timing:prospective
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Parisa Hajighasem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5351
Email address
ib.hajighasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-05, 1399/09/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of clinical and microbiological efficacy of nystatin suspension in the management of denture stomatitis
Public title
clinical and microbiological efficacy of nystatin suspension in the management of denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Denture stomatitis type II based on Newton classification
use complete denture of maxilla partial class I(Bilateral edentulous areas with no teeth behind them)At least for a year
Do not take any antifungal drugs associated with fungal infections
Having general health
Patient satisfaction and cooperation
Exclusion criteria:
Patients diagnosed with diabetes, anemia, immunosuppression, cancer treatment (radiotherapy and chemotherapy)
Receiving antifungal medication or antibiotics or steroids in the last 4 weeks
People with zerostomia
smokers
Pregnant and lactating women
People who are allergic to azole or polyene groups
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
School of Dentistry, Shahid Beheshti university of medical sciences, Daneshjoo Blvd, Evin , Chamran high way
City
Tehran
Province
Tehran
Postal code
1983963113بزرگراه
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SBMU.DRC.REC.1399.039
Health conditions studied
1
Description of health condition studied
denture stomatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total candida count
Timepoint
0,14,21,28
Method of measurement
Microbiological survey
2
Description
remission time
Timepoint
14,21,28 day
Method of measurement
examination
Secondary outcomes
1
Description
albicans candida count
Timepoint
0,14,21,28
Method of measurement
microbiological survey
Intervention groups
1
Description
Intervention group: nystatin suspension 100000 unit/ml,Four times a day in the amount of 30 drops,One minute mouthwash,Until complete recovery,Emad Darman Pars pharmaceutical company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
dental school of Shahid Beheshti university
Full name of responsible person
Parisa Hajighasem
Street address
School of Dentistry, Shahid Beheshti university of medical sciences, Daneshjoo Blvd, Evin , Chamran high way
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
ib.hajighasem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
School of Dentistry, Shahid Beheshti university of medical sciences, Daneshjoo Blvd, Evin , Chamran high way
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
ib.hajighasem@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Hajighasem
Position
3 Postgraduate Student of Oral Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti university of medical sciences, Daneshjoo Blvd, Evin , Chamran high way
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Email
ib.hajighasem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Hajighasem
Position
Post graduate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,Shahid Beheshti university of medical science,Daneshjoo Blvd,Evin,Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Fax
Email
ib.hajighasem@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parisa Hajighasem
Position
Post graduate
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry,Shahid Beheshti university of medical science,Daneshjoo Blvd,Evin,Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5351
Fax
Email
ib.hajighasem@gmail.com
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