Comparative effects of Saliva officinalis gel (Salvizan) and Triamcinolone asetonide gel in recurrent aphthous stomatitis.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients, a random number lottery was used for randomization.
Settings and conduct
The study site was the Department of Oral Diseases, School of Dentistry, Isfahan University of Medical Sciences. Sixty patients with recurrent aphthous stomatitis will be given triamcinolone gel to half of the patients and Salvizan gel to the other half until the patients recover.
Pain is assessed on days 0, 1, 3, and 5 using the VAS system. This study is performed in a double-blind manner. The participant and the researcher in this study are blind, so that the drugs are poured into the same tubes by a third person and one group is given code A and the other group is given code B. At home, the patient applies one centimeter of gel to the lesion three times a day for complete recovery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with minor aphthous ulcers
Have not taken any medication
Do not have any systemic disease
No entry criteria : pregnant and lactating people
Sensitivity to herbal products
Intervention groups
Control group : Teriadent drug, three times a day, until the wound is completely healed
Intervention group : Salvizan gel, three times a day, until the wound is completely healed
Main outcome variables
Pain ; Duration of pain relief; Wound healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100202003251N7
Registration date:2021-10-13, 1400/07/21
Registration timing:retrospective
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Atefeh Tavangar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2814
Email address
tavangar@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-24, 1400/01/04
Expected recruitment end date
2021-09-26, 1400/07/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of saliva officinalis gel (salvizan) and triamcinolone asetonide gel in recurrent aphthous stomatitis.
Public title
Evaluation of the effect of salvizan gel on aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 18 years
Non-pregnant and non-breastfeeding women
The patient's ability to stay on during the study period.
Exclusion criteria:
Pregnancy
Breastfeeding women
People who are sensitive to herbal products
Systemic patients such as:, patients with primary or acquired immunodeficiency
Patients with a history of taking anti-inflammatory drugs and corticosteroids
Major aphthous ulcers and Herpetiform
Wounds with durability longer than 48 hours
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
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
Random Allocation Law :
For this purpose, first determine a total sample volume, then randomly assign a set of them to group A and the rest to group B.
In this study, with a sample size of 60 drugs, 30 drugs for intervention group A and 30 drugs for intervention group B are placed in a lottery container and then the drugs are randomly removed from the container without replacement and the sequence created is recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are placed in the same tubes in terms of sex, color and size and are divided into two codes A and B. However, the patient and the clinician do not know the nature of the drugs and the study is completely double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib S, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.834
Health conditions studied
1
Description of health condition studied
Aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Size of wound
Timepoint
The first, third and fifth days after the intervention
Method of measurement
Ruler
2
Description
Pain
Timepoint
Before the study, the first, third and fifth days after the start of the study
Method of measurement
Visual Analogue Scale
3
Description
Healing ulcer
Timepoint
Before start and after end of the study
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Triadent 0.1%, one centimeter of gel three times a day, until complete healing of wounds and pain on days 0, 1, 3 and 5 marked in the VAS (Visual Analogue Scale) questionnaire Be, abandon the pharmaceutical company
Category
Treatment - Drugs
2
Description
Intervention group: Salvizan 0.1%, one centimeter of gel three times a day, until complete healing of wounds and their pain on days 0, 1, 3 and 5 marked in the VAS (Visual Analogue Scale) questionnaire Be, Gol Daroo Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry school of Isfahan University of Medical Science
Full name of responsible person
Atefeh Tavangar
Street address
Hezar Jerib Street, Isfahan University of Medical Science, Dentistry school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
tavangar@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jerib Street, Isfahan University of Medical Science, Dentistry school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
tavangar@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Tavangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jerib Street, Isfahan University of Medical Science, Dentistry school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
tavangar@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Tavangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jerib Street, Isfahan University of Medical Science, Dentistry school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
tavangar@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Tavangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezar Jerib Street, Isfahan University of Medical Science, Dentistry school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
tavangar@dnt.mui.ac.ir
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
Not applicable
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