Comparison of V-One mouthwash (ginger); Irsha (ginger and yarrow) and nystatin on the amount of oral mucosal erythema in people with denture stomatitis type 2: a clinical trial
Comparison of the effect of V-One ginger mouthwash; Irsha's ginger and yarrow mouthwash and nystatin in the treatment of denture stomatitis type 2, through a clinical trial, in the Faculty of Dentistry of Tehran Islamic Azad University of Medical Sciences in 2023-2024
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 54 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This double-blind clinical trial study is conducted on all patients with denture stomatitis type II referred to the Department of Oral Diseases / Complete Prosthetics of the Faculty of Dentistry of Islamic Azad University in 2023-2024.
None of the participants nor the researcher knows about the type of mouthwash.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with type II erythematous stomatitis dentures; ability to use mouthwash. Exclusion criteria: People who are allergic to ginger, yarrow and nystatin mouthwash; have a diet rich in ginger; suffer from diabetes; hypoparathyroidism; history of chemotherapy and radiotherapy; use of antibiotics and anti-fungals in the last 4 weeks
Intervention groups
Intervention Group 1: using V One mouthwash; Intervention Group 2: using Irsha mouthwash; Control Group: using Nystatin suspension
Main outcome variables
Area of erythema in mucosa
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231021059788N1
Registration date:2024-01-16, 1402/10/26
Registration timing:prospective
Last update:2024-01-16, 1402/10/26
Update count:0
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Sayyed Mohammad Zamaan Mousavi Kaani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5554 6976
Email address
m.mousavik@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of V-One mouthwash (ginger); Irsha (ginger and yarrow) and nystatin on the amount of oral mucosal erythema in people with denture stomatitis type 2: a clinical trial
Public title
Comparison of the effect of V-One mouthwash (ginger) and Irsha mouthwash (ginger and yarrow) and nystatin in the treatment of denture osteomatitis type 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of symptoms of oral candidiasis in the patient's palate
Being literate in reading and writing
Being able to use mouthwash
Exclusion criteria:
Individuals who are allergic to ginger, yarrow and/or nystatin mouthwash
Individuals who have a diet rich in ginger
having diabetes
Having hypoparathyroidism
History of chemotherapy and radiotherapy
Use of antibiotics and antifungals during the last 4 weeks
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Bottles that are completely similar in appearance to each other, are poured by one of the three drugs that is going to be examined in the study. For each drug there will be 18 bottles and each bottle suffices for use of a patient during one week and after one week it must be refilled. The bottles are numbered randomly from 1 to 54 and the characteristics of bottles are recorded in the database. A simple randomization method will be used. During the delivery of the medicine to the patient, random number generation software (Microsoft Excel 2013) will be used to assign a random number from 1 to 54 to each patient, and the person receives a bottle containing medicine with the corresponding number. Because it takes time to find related people to enter the study and their visit to the clinic for initial examination and required documentation and signing informed consent is done on different days, therefore, the people participating in the study do not have any contact with each other and hence allocation concealment is implemented in practice.
Blinding (investigator's opinion)
Double blinded
Blinding description
Bottles containing mouthwash are already filled and numbered by the supervisor. The specifications of the mouthwash are recorded and kept by him in the sheet. The bottles containing the mouthwashes are completely similar in appearance and the contents of the bottles are not visible from the outside
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Dentistry, Tehran Islamic Azad University of Medical Sciences
Street address
No. 4; Nistan Dahom; Pasdaran street
City
Tehran
Province
Tehran
Postal code
19585/175
Approval date
2023-10-14, 1402/07/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.094
Health conditions studied
1
Description of health condition studied
Denture Stomatitis
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
The area of erythema in the mucosa
Timepoint
Measurement of mucosal erythema area at the beginning of the study (before the intervention) and 7, 14 and 21 days after the start of mouthwash use.
Method of measurement
Area measurement module in ImageJ image processing software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: use of Irsha's ginger and yarrow mouthwash. The concentration of effective ingredients is 25%. Five ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Shafa Pharmaceutical Laboratory - Tehran - Iran
Category
Treatment - Drugs
2
Description
Intervention group 2: use of ginger mouthwash V One. The concentration of effective ingredients is 25%. 5 ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Rojin company. Tehran Iran
Category
Treatment - Drugs
3
Description
Intervention group: Use of nystatin suspension. 100000 units. 5 ml of mouthwash is swirled in the mouth 4 times a day for 3 minutes each time and then thrown away. Produced by Jaber Bin Hayan Company - Tehran - Iran
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Azad University of Tehran
Full name of responsible person
ِDr Arezoo Alaei
Street address
No. 4; Nistan Dahom; Pasdaran street
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
m.mousavik@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo alaei
Street address
No. 4; Nistan Dahom; Pasdaran street
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
m.mousavik@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
by myself
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Mohammad Zamaan Mousavi Kaani
Position
student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
No. 4; Nistan Dahom; Pasdaran street
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
m.mousavik@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Mohammad Zaamaan mousavi
Position
student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
No. 4; Nistan Dahom; Pasdaran street
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 2256 4571
Email
m.mousavik@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sayyed Mohammad Zamaan Mousavi Kaani
Position
Student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Unit 2, No. 15, 74th alley, South Miad Street, Khaniabadno Town
City
Tehran
Province
Tehran
Postal code
19585/175
Phone
+98 21 5554 6976
Fax
Email
M.mousavik@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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