Evaluation of the lesion size and candida colony count before and after using Punica granatum mouthwash and treatment with nystatin and comparing them
Design
This is a parallel, double blind randomized clinical trial (phase 2) with control group on twenty four patients in each group who will be enrolled randomly by block randomization.
Settings and conduct
Participants with denture stomatitis attending the Shiraz University of Dental School will be enrolled in this study. In the intervention group, nystatin therapy and Punica granatum mouthwash will be considered 3 times a day for 15 days. In the control group, just nystatin therapy will be prescribed. Their effect will be compared. The data analyzer and also the outcome assessor will not know the type of treatment, and both will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria : patient with denture stomatitis
exclusion criteria: diabetic patient, patient who used antibiotic or anti fungal or corticosteroids within last 3 months, immune suppressed patients.
Intervention groups
Intervention group: Patients with denture stomatitis will be treated by nystatin solution (Jaber-ebn-Haian company, Tehran, Iran). In addition, Punica granatum mouthwash will be prescribed for patients three times a day for 15 days.
Control group: Patients with denture stomatitis will be treated with nystatin solution three times a day for 15 days.
Main outcome variables
lesion size, colony count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N14
Registration date:2022-03-28, 1401/01/08
Registration timing:prospective
Last update:2022-03-28, 1401/01/08
Update count:0
Registration date
2022-03-28, 1401/01/08
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Antifungal Effect of Punica granatum Mouthwash on Oral Candidiasis: a clinical trial
Public title
Antifungal Effect of Punica granatum Mouthwash on Oral Candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Edentulous denture-wearing patients with denture stomatitis
Exclusion criteria:
Immunosuppressive patient
Diabetic patient
The patient who used antibiotic, antifungal medication, or corticosteroid during the last 3 months
patients under Chemotherapy or radiotherapy
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Each block with 4 allocations, consisting 2 allocation for intervention and 2 for control group will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 48 participants (12 blocks).
The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 48 cards a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on order of enrollment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and statistical analyzer will be blind to the prescribed treatment. Nystatin oral suspension will be prescribed in both groups. In the intervention group, Punica granatum mouthwash will be added. Since the outcome analyzer will be different from the one who prescribed the mouthwashes, the outcome assessor will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Approval date
2019-07-07, 1398/04/16
Ethics committee reference number
IR.SUMS.DENTAL.REC.1398.074
Health conditions studied
1
Description of health condition studied
Denture stomatitis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis
Primary outcomes
1
Description
Lesion size
Timepoint
Day 1 and 15 and 30
Method of measurement
Newton's classification
2
Description
candida colony count
Timepoint
Day 1 and 15 and 30
Method of measurement
CFU/ml colony count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. In addition, Punica granatum mouthwash will be prescribed 3 times a day for 15 days.
Category
Treatment - Drugs
2
Description
Control group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian company) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Fateme Lavaee
Street address
Shiraz Dental School, Ghasrdasht street, Shiraz
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 917 702 9159
Email
dental@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Shiraz university of Medical Sciences, Zand street, Iran
City
Shiraz
Province
Fars
Postal code
7186782559
Phone
+98 71 3212 2438
Email
memarpourm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data will be shared after deidentification of participants.
When the data will become available and for how long
6 months after publication data will become available.
To whom data/document is available
The researchers in academic institutions.
Under which criteria data/document could be used
The researchers in academic institutions.
From where data/document is obtainable
The researchers in academic institutions can email responsible person and request information.
What processes are involved for a request to access data/document
The researchers in academic institutions can email responsible person and request information.