The aim of this study is to compare the effects of grape seed extract and nystatin mouthwash in patients with denture stomatitis.
Design
Clinical trial with a sample size of 20 patients in two parallel groups, without blinding
Settings and conduct
This study will be performed among patients referring to Tabriz Dental School. Patients will be randomly divided into two groups. At first, the size of the intra-oral erythema will be recorded. In the first group, 20 drops of grape seed extract will be used every 8 hours and in the second group 20 drops of nystatin mouthwash will be used every 8 hours. Then the dimensions of intra-oral erythema will be recorded and compared 5,10,15, 20 days later.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering denture stomatitis erythematous; having a healthy denture without leaping and discoloration. Exclusion criteria: use of anti-fungal drugs, antibiotics and corticosteroids in the past month; allergy to nystatin or grape seed extract.
Intervention groups
In the first group, the patients will be received the grape seed extract and in the second group, they will be received nystatin mouthwash.
Main outcome variables
Dimensions of Denture Stomatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150628022951N6
Registration date:2018-09-05, 1397/06/14
Registration timing:prospective
Last update:2018-09-05, 1397/06/14
Update count:0
Registration date
2018-09-05, 1397/06/14
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-12, 1397/07/20
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Grape seed extract and Nystatin mouthwash on denture stomatitis
Public title
Effect of grape seed extract on denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering denture stomatitis erythematous
Having a healthy denture without leaping and discoloration
Exclusion criteria:
Use of anti-fungal drugs, antibiotics and corticosteroids in the past month
Allergy to nystatin and grape seed extract
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. Each person will be assigned a code, and according to the random number table, each person will be placed in a group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2016-08-05, 1395/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.423
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
Dimensions of denture stomatitis
Timepoint
Pre-intervention, 5,10,15, 20 days after intervention
Method of measurement
Measuring the length and width of the erythema with a digital ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rinse out 20 drops of grape seed extract every 8 hours
Category
Treatment - Drugs
2
Description
Control group: Rinse out 20 drops of nystatin every 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty
Full name of responsible person
Sanam Khanmoradi
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
sanam.khanmoradi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Joyban
Street address
Research deputy of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
researchteam.tbzmed@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 9680
Fax
Email
eslamihosein56@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 9680
Fax
Email
eslamihosein56@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Eslami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 9680
Fax
Email
eslamihosein56@yahoo.com
Web page address
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
Demographic information of patients and data related to the outcomes of the study will be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Sharing data for meta-analysis
From where data/document is obtainable
Please contact Dr.Hossein Eslami by e-mail: eslamihosein56@yahoo.com
What processes are involved for a request to access data/document
After ensuring that your claim is true, these data will be sent to you.