Effects of Scrophularia striata Extract on Recurrent aphthous stomatitis recovery
Design
four arm parallel group randomised trial with blinded outcome.The number of participants in the study will be 100 patients.
Settings and conduct
This clinical trial will be conducted at the Dental School of Ilam University of Medical Sciences.Patients will be randomly assigned to intervention and control groups with tow- way blindness.
Participants/Inclusion and exclusion criteria
People with recurrent aphthous stomatitis less than 3 days old and over 7 years of age.
People with underlying illnesses, recipients of drugs affecting aphthous stomatitishealing in the past three months and pregnant mothers will not be included.
Intervention groups
The interventional groups were 10%, 15% solution, control diphenhydramine syrup or serum physiology
Main outcome variables
Reduce inflammation and pain, healing and recurrent aphthous stomatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180327039152N1
Registration date:2018-04-28, 1397/02/08
Registration timing:registered_while_recruiting
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Masoumeh Shohani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 1286
Email address
shohani-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-06, 1397/01/17
Expected recruitment end date
2019-03-10, 1397/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Scrophularia striata Extract on pain relief aphthous stomatitis
Public title
Effects of Scrophularia striata Extract on Recurrent aphthous stomatitis recovery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of minor oral aphthous by specialist dentistry
Life span is 3 days or less.
Age over 7 years.
Exclusion criteria:
Children under 7 years of age and those who are nervous and anatomical can not gargle
Pregnancy
Atypical cases of pests and cases suspected of Behcet's syndrome,
Inflammatory bowel disease, or history of any type of underlying illness that can predispose a person to aphthous .
Drug and tobacco use
Taking effective medications for wound healing, such as corticosteroids, anticoagulants, immunosuppressive drugs, chemotherapy
Concomitant use of any topical drug for the treatment of aphthous
The use of any type of topical or systemic analgesic,
Use of any systemic pest treatment over the past 3 months
Age
From 7 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
We use the random block randomization method.In this way, we will produce eight paper sheets. we write on the two sheetof the letter I1 means Intervention 1(Solution 10%), On the two sheetof the letter I2 means Intervention 2(Solution 15%), On the two sheetof the letter C1 means Control1(Diphenhydramine syrup), On the two sheetof the letter C2 means Control2(Salin serum).
Blinding (investigator's opinion)
Double blinded
Blinding description
Mix the sheets together and place them in the drawer.By referring to each eligible patient, one of the sheets is drawn randomly. Based on this drawn sheet (I1, I2 or C1, C2), they will be assigned to one of the two intervention or control groups.It should be noted that the drawn sheets will not be returned to the drawer until all eight papers have been drawn out.after having drawn out randomly every eight sheets,all sheets are returned to drawer again and the above action again for the next eight to reach the desired sample size will continue.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Pazhohesh blv.
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2018-04-07, 1397/01/18
Ethics committee reference number
ir.medilam.rec.1396.128
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 relief for recurrent oral aphthous
Timepoint
At the first meeting with the participants and days 1, 2, 3, 5 and 7 after starting treatment
Method of measurement
use of visual analog scale(VAS)
2
Description
Wound healing rate
Timepoint
Admission and days 3 and 7
Method of measurement
Measuring the wound using a periodontal probeو in millimeters
Secondary outcomes
1
Description
The rate of recurrence of ulcers
Timepoint
Up to three months monthly
Method of measurement
Questions about the recurrence of ulcers by phone
Intervention groups
1
Description
Intervention group: First: 10% solution
Category
Treatment - Drugs
2
Description
Intervention group:second: 15% solution
Category
Treatment - Drugs
3
Description
Control group: First: Diphenhydramine syrup
Category
Placebo
4
Description
Control group: second: Salin serum
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Clinic, Ilam University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Soltani
Street address
Ayatollah Heidari Ave
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 1335 1783
Email
mr-soltani77@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Kalvandi
Street address
Pazhohesh Ave
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Fax
+98 84 3223 5721
Email
kalvandi-gh@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Shohani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pazhohesh Blv.
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7114
Fax
+98 84 3222 7114
Email
shohani-m@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Shohani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pazhohesh Blv.
City
Ilam
Province
Ilam
Postal code
6937177143
Phone
+98 84 3222 7114
Fax
+98 84 3222 7114
Email
shohani-m@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Shohani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Pazhohesh Blv.
City
Ilam
Province
Ilam
Postal code
6937177143
Phone
+98 84 3222 7114
Fax
+98 84 3222 7114
Email
shohani-m@medilam.ac.ir
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
Adherence to the principles of ethics in research
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
According to the ethics of research, sharing of individual data will not be done.
When the data will become available and for how long
Start the access period 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
Use of data under the supervision and agreement of the Deputy of Research and Technology of the University and the project implementer
From where data/document is obtainable
Contact the University of Technology Research and Technology
researcher project ilmplementer and guidance
shohani-m@medilam.ac.ir
What processes are involved for a request to access data/document
Contact to researcher project ilmplementer and guidance
Information acquisition
Contact the University of Technology Research and Technology
Written request
Obtain permission
Comments
It is suggested that you coordinate with the researcher implementer if you have any questions.
shohani-m@medilam.ac.ir