Designing and fabricating oral Bioadhesive from Onosma Bulbotricum and study of its therapeutic effect on the patient with Recurrent Aphthous Stomatitis (RAS)
Designing and fabricating oral Bioadhesive from Onosma Bulbotricum and study of its therapeutic effect on the patient with Recurrent Aphthous Stomatitis (RAS)
Design
This study is a non-blinded clinical trial. The research population will be included all patients referring to Kermanshah Dental School.120 eligible patients will be selected conveniently and randomly will be assigned to two intervention and control groups.
Settings and conduct
This study that will be conducted in Dental School of Kermanshah is a non-blinded one. Patients in both intervention and control groups are visited after starting treatment every other day for one week
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aphthous stomatitis occurs at least three times a year; Age between 18 and 60 years
Exclusion criteria:pregnant women
Intervention groups
The intervention group will receive oral Bioadhesive extracted from Onosma Bulbotricum (from borage species) topically for 3 days (several times a day) for a week.
The control group will receive 1% triamcinolone topical gel (with trademarked of Teriadent) three days a week (several times a day) for one week.
Main outcome variables
Pain, number of oral lesions, average diameter of oral lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N150
Registration date:2020-05-26, 1399/03/06
Registration timing:registered_while_recruiting
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and fabricating oral Bioadhesive from Onosma Bulbotricum and study of its therapeutic effect on the patient with Recurrent Aphthous Stomatitis (RAS)
Public title
Designing and fabricating oral Bioadhesive from Onosma Bulbotricum and study of its therapeutic effect on the patient with Recurrent Aphthous Stomatitis (RAS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aphthous stomatitis occurs at least three times a year
Age between 18 and 60 years
Exclusion criteria:
pregnant women
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control 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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.KUMS.REC.1398.1150
Health conditions studied
1
Description of health condition studied
recurrent aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Pain
Timepoint
The second day after starting treatment as every other day for one week
Method of measurement
Based on a visual pain scale (VAS)
2
Description
number of oral lesions
Timepoint
The second day after starting treatment as every other day for one week
Method of measurement
By a specialist in oral, maxillofacial and facial diseases
3
Description
the average diameter of oral lesions
Timepoint
The second day after starting treatment as every other day for one week
Method of measurement
Using a ruler
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive oral Bioadhesive extracted from Onosma Bulbotricum (from borage species) topically for 3 days (several times a day) for a week.
Category
Treatment - Drugs
2
Description
The control group will receive 1% triamcinolone topical gel (with trademarked of Teriadent) three days a week (several times a day) for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Dr. Masoome Eivazi
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
masoomeeivazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
rtahvilian@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Masoome Eivazi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
masoomeeivazi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Tahvilian
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati Ave, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
rtahvilian@kums.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
Send E-mail to the responsible for the update to get the documentation
What processes are involved for a request to access data/document
Documentation will be emailed within a 15-day timeframe