1.Determining the severity of denture stomatitis in the group using ozone-containing paste on the first and fifteenth.
2.Determination of denture stomatitis severity in the group using nystatin on the first and fifteenth days.
Comparison of two groups in terms of denture stomatitis severity in the first and fifteenth days.
Design
This study was performed as an experimental, single-blind clinical trial. Patients were randomly divided into two groups using hexagonal blocks. One group received ozone paste and the other group (control) received nystatin. To determine the sample size, first in a pilot study, 30 people from each group were included in the study. After collecting the data, using it, the sample size was estimated and the study continued until the calculated sample number was reached.
Settings and conduct
This study was performed as an experimental, single-blind clinical trial. These patients were divided into two groups. Visits took place on the first, seventh and fifteenth days. The drugs delivered to patients in both groups had the same packaging. Then the drug and method of use were given to the patient. The research site was Semnan dental clinics.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients using denture with stomatitis denture lesions in the palate.
Conditions of non-entry: denture with poor compliance. Prohibition of prescribing ozone. Prohibition of prescribing nystatin.
Intervention groups
Ozone paste was delivered to patients as a tube for two weeks for the case group. Nystatin (purchased from products of Jabraban Hayan Pharmaceutical Company) was given as an ointment to patients in the control group for one week.
Main outcome variables
Do not use nystatin and ozone paste.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201026049146N1
Registration date:2021-01-04, 1399/10/15
Registration timing:registered_while_recruiting
Last update:2021-01-04, 1399/10/15
Update count:0
Registration date
2021-01-04, 1399/10/15
Registrant information
Name
Sajad Karajian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4335 3422
Email address
sajadkarajian11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Ozone Containing paste and Nystatin paste Sseverity of Denture Stomatitis among Denture wearer patients
Public title
Comparison of Effectiveness of Ozone Containing paste and Nystatin paste Sseverity of Denture Stomatitis among Denture wearer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 40 to 80 years old using Denture with Denture lesions of the Stomatitis in the palate
Exclusion criteria:
Denture with poor compliance
Prohibition of prescribing ozone
Prohibition of prescribing nystatin
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization، Individual، Random Number Tables.
Randomized permutation blocks (block 6).
Using Excel software to generate random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the allocation of study groups.Ozone and nystatin paste were given to patients in similar packages and patients were unaware of the allocation to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
17 Shahrivar Blvd. Semnan Dental School
City
Semnan
Province
Semnan
Postal code
3518794431
Approval date
2020-08-25, 1399/06/04
Ethics committee reference number
IR.SEMUMS.REC.1399.173
Health conditions studied
1
Description of health condition studied
Denture Stomatitis
ICD-10 code
K12.1
ICD-10 code description
Other forms of stomatitis
Primary outcomes
1
Description
Patients with denture stomatitis
Timepoint
Measurement of denture stomatitis severity in the first and fifteenth days
Method of measurement
Examination form for patients with denture stomatitis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ozone paste was delivered to patients as a tube for two weeks for the case group.The ozone group placed the ozone paste in the maxilla denture 4 times daily after each meal after cleaning the denture with a toothbrush, and the denture did not come out until the next meal.
Category
Treatment - Drugs
2
Description
Control group: Nystatin was given as an ointment to patients in the control group for one week. In the nystatin group, the ointment was used 4 times a day according to the instructions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Dental School
Full name of responsible person
Sajad Karajian
Street address
17 Shahrivar Boulevard
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
Sajadkarajian11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Sajad Karajian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
17 Shahrivar Boulevard
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
Sajadkarajian11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Farzad Ghorbani
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
17 Shahrivar Boulevard
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
farzadghorbani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sajad Karajian
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
17 Shahrivar Boulevard
City
Semnan
Province
Semnan
Postal code
3518794431
Phone
+98 23 3332 4700
Email
Sajadkarajian11@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