1-Determine and compare the middle score of the severity of irritation aphthous ulcer before intervention in two groups
2-Determine and compare the mean score of the maximum diameter aphthous ulcer before intervention in two groups
3-Determine and compare the mean score of the reduce pain and irritation aphthous ulcer in two groups
4-Determine and compare the mean score of the reduce size aphthous ulcer in two groups
5-Determine and compare the middle score of the severity of irritation aphthous ulcer before and after 3,5,7 days using ointment in two groups
6-Determine and compare the mean score of the maximum diameter aphthous ulcer before and after 3,5,7 days using ointment in two groups
Design
Double blind study in two groups with minimum sample size of 30 samples and patient in each group selected from encoded random numbers table
Settings and conduct
For double blinding, drugs is divided by pharmacologist to A and B, the doctor and patient are not aware of the type of drug
Participants/Inclusion and exclusion criteria
The age of the patient is between 20 and 40 years
Less than a day from the onset of a wound
Patient has not used any other treatment for the wound before referral
Patients agree to cooperate with this research patient has not systemic disease related to aphthous lesion and there are no suspected signs of systemic disease associated with ulcer
exclusion:
Use of other medications plus ointment for treatment
Do not use the medicine as recommended according to the patient
Missing follow up
Lesions in tonsils and 1/3 posterior of oral
Intervention groups
first group administration of Phenytoin; second group administration of Triadent on oral aphtous lesions and evaluation of the severity of pain, size of the wound and the recovery time before and after administration.
Main outcome variables
Evaluation of pain and burning symptoms and size of ulcer present in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081109001442N3
Registration date:2019-02-10, 1397/11/21
Registration timing:registered_while_recruiting
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Hakimeh Ahadian
Name of organization / entity
Faculty of Dentistry, Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1625 5881
Email address
dr_ahadian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of phenytoin and triamcinolone on the minor aphthous ulcer
Public title
Comparison of the effect of phenytoin and triamcinolone on the minor aphthous ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the patient is between 20 and 40 years
Less than a day from the onset of a wound
Patient has not used any other treatment for the wound before referral
Patients agree to cooperate with this research
Patient has not systemic disease related to aphtouse lesion and there are no suspected signs of systemic disease associated with ulcers
Exclusion criteria:
Use of other medications plus ointment for treatment
Do not use the medicine as recommended according to the patient
Missing follow up
Lesion in tonsils and 1/3 posterior of oral
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients who have been randomly assigned to numbers encoded using numbers, 30 patients using A drug(mucous adhesive phenytoin ) and 30 patients using B drug(mucous adhesive triadent).
Blinding (investigator's opinion)
Double blinded
Blinding description
The ointment is divided by the pharmacist which is not known to the patient and physician
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Dahe fajr boulevard, shahid sadoughi of dental university
City
Yazd
Province
Yazd
Postal code
89195165
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.SSU.REC.1397.116
Health conditions studied
1
Description of health condition studied
Oral aphthous ulcer
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
recovery aphthous lesion
Timepoint
Evaluation of severity of pain and diameter of lesion and duration of recovery after 3 , 5 and 7 days using.
Method of measurement
VAS(Visual Analogue Scale) / measuring the wound by millimeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: mucus adhesive phenytoiin oint , three times a day, for a week
Category
Treatment - Drugs
2
Description
Intervention group: mucus adhesive triadent oint , three times a day, for a week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental University of Shahid Sadoughi Yazd
Full name of responsible person
Yasaman Sabaghzadegan
Street address
Dahe Fajr Blvd, Shahid Sadoughi of Dental University
City
Yazd
Province
Yazd
Postal code
89195165
Phone
+98 35 3621 2222
Email
yasisabagh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Khezri
Street address
Dahe Fajr Blvd, Shahid Sadoughi of Dental University
City
Yazd
Province
Yazd
Postal code
89195165
Phone
+98 35 3621 2222
Email
yasisabagh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Yasaman Sabaghzadegan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd, Shahid Sadoughi of Dental University
City
Yazd
Province
Yazd
Postal code
89195165
Phone
+98 35 3621 2222
Email
yasisabagh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Yasaman Sabaghzadegan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd, Shahid Sadoughi of Dental University
City
Yazd
Province
Yazd
Postal code
89195165
Phone
+98 35 3621 2222
Email
yasisabagh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Yasaman Sabaghzadegan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dahe Fajr Blvd, Shahid Sadoughi of Dental University
City
Yazd
Province
Yazd
Postal code
89195165
Phone
+98 35 3621 2222
Email
yasisabagh@yahoo.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