The aim of this study to compare the effect of the Salvizan gel with Triadent in the Recurrent Aphthous Stomatitis (RAS) treatment. 30 healthy individuals with a history of minor RAS and suffering from a new lesion formed during the last 24 hours. Participate in this research. Patients with other systemic problems such as diabetes will be excluded. Participants are randomly divided into two groups. Prior to drug intervention pain level is determined using visual analogue scale(VAS), and the ulcer size is measured by a Shablon. 0.1% Triadent ointment is applied to the controls and Salvizan gel to the experimental group. Participants are asked to place the medication in the wound site. 3 times a day for 30 seconds. The pain level and the wound size is reevaluated at the second and sixth day of after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020219698N2
Registration date:2015-08-12, 1394/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-12, 1394/05/21
Registrant information
Name
Fatemeh Babadi
Name of organization / entity
Ahwaz jundi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5319
Email address
babadi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundi Shapur University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Salvizan gel versus teriadent on the treatment of recurrent aphthous stomatitis
Public title
Salvizan gel effect on the treatment of recurrent aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy individuals with a minor RAS wich has 24 hours passed from their oral lesion
Exclusion Criteria: Systemic diseases such as diabetes, digestive problems, pregnancy
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundi Shapur University Of Medical Sciences
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Univercity Of Medical Sciences , Golestan
Postal code
Approval date
2015-03-14, 1393/12/23
Ethics committee reference number
IR.AJUMS.REC.1394.12
Health conditions studied
1
Description of health condition studied
Oral Ophtus
ICD-10 code
K12.0
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
Pain intensity
Timepoint
Before intervention, 2 and 6 days after intervention
Method of measurement
According VAS
Secondary outcomes
1
Description
Ulcer size
Timepoint
Before intervention , 2 and 6 days after intervention
Method of measurement
According mm
Intervention groups
1
Description
intervention group: Salvizan gel, Local, Three times a day, 30 Seconds
Category
Treatment - Drugs
2
Description
Controls Group : Teriadent ointment 0.1%, Local, Three times a day, 30 Seconds
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
Full name of responsible person
Dr Fatemeh Babadi
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Mohammad Mousavi
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundi Shapur University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Specialist of Oral and Maxillofatioal Medicen
Other areas of specialty/work
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3443 4574
Fax
Email
babadi-f@ajums.ac.ir , babadi.fatemeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Specialist Oral And Maxillofatioal Disease
Other areas of specialty/work
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3443 4574
Fax
Email
babadi-f@ajums.ac.ir , babadi.fatemeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Specialist Oral And Maxillofatioal Disease
Other areas of specialty/work
Street address
Jundi Shapur University Of Medical Sciences, Golestan street, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3443 4574
Fax
Email
babadi-f@ajums.ac.ir , babadi.fatemeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)