effect of sumac spray on minor recurrent aphthous stomatitis treatment
Design
Clinical trial has a control group, with parallel groups, double-blind, randomized
Settings and conduct
This clinical trial study will conducted on patients with a recurrent aphthous stomatis attended to the oral disease Department of Zahedan Dental School ., the first patients group received somac spray and the patients are asked to take the drug four times a day (one hour before meals and 20 minutes before bedtime) Once or twice each time for five days, and avoid drinking or eating for up to half an hour after using the drug. The person will be asked to dry the wound and then use drug at the site of the wound
Participants/Inclusion and exclusion criteria
The existence of 1-5 wounds less than 24h with a size of less than 10mmis(if there is more than one wound, the average diameter of all wounds will prevail), the pain in the affected area, the age above 18 years, lack of history of drug hypersensitivity, non pregnant and no lactation , Lack of history of systemic disease, non-steroid anti-inflammatory medication or oral antihistamines one month before entering the study, lack of treatment with systemic or immunosuppressive medications a month before entering the study, treatment of wounds with any drug before entering Study, lack of treatment with systemic antibiotics 2weeks before entering the study, the absence of adjacent trauma ulcers caused by sharp tooth edges, broken healing, orthodontic appliance or denture prosthesis
Intervention groups
1. control placebo user 2. cortichosteroid user
Main outcome variables
the effect of somac spray consumption on recurrent aphthous stomatitis treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191012045067N5
Registration date:2022-01-01, 1400/10/11
Registration timing:prospective
Last update:2022-01-01, 1400/10/11
Update count:0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
masoomeh shirzaiy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3321 1135
Email address
shirzaiy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of sumac spray on minor recurrent aphthous stomatitis treatment
Public title
Evaluation of effect of sumac spray on minor recurrent aphthous stomatitis treatment
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The existence of 1-5 wounds less than 24h
its size of less than 10mm (if there is more than one wound, the average diameter of all wounds will prevail)the pain existence in the affected area
the age above 18 years
lack of history of drug hypersensitivity
non pregnant and no lactation
Lack of history of systemic disease
Lack of non-steroid anti-inflammatory medication or oral antihistamines use one month before the study entrance
lack of treatment with systemic or immunosuppressive medications a month before the study entrance
treatment of wounds with each drug before study entrance
lack of treatment with systemic antibiotics 2weeks before the study entrance
the absence of aphthea ulcer adjacent trauma ulcers caused by sharp tooth edges, broken restorative , orthodontic appliance or partial denture prosthesis
Exclusion criteria:
No attend of person with recurrent aphthous stomatitis in fallow up period
non-controlled diabetes
non-controlled hypertension
pregnancy or lactation
active or known infection
severe mental disorder
require of treatment with antibiotics during the desired treatment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
patient and analyzer don't know about drugs and placebo also which one is drug and which one is placebo
Placebo
Used
Assignment
Parallel
Other design features
effectiveness of somac in the treatment of patients with recurrent aphthous stomatitis
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.ZAUMS.REC.1400.205
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
recurrent aphthous stomatitis
Timepoint
Day Zero, second, seventh after the start of treatment
Method of measurement
Visual Analogue Scale,Periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: People with recurrent aphthous ulcer somac spray 4 times a day for 5 days (The patient asked to use the spraay four times a day (one hour before meals and twenty minutes before bedtime) for five days and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug)
Category
Treatment - Drugs
2
Description
Control group: Control group: People with recurrent aphthous ulcer use placebo 4 times a day for 5 days (The patient asked to use the spray containing essence (placebo) four times a day (one hour before meals and twenty minutes before bedtime) for five days, and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug)
Category
Placebo
3
Description
Intervention group: Intervention group: People with recurrent aphthous ulcer use corticosteroid 4 times a day for 5 days(The patient asked to use the orabase containing corticosteroid (triamcinolone) four times a day (one hour before meals and twenty minutes before bedtime) for five days, and half hour after using the drug, Avoid eating and drinking. The person asked to dry the wound and then use the drug)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Dental School
Full name of responsible person
Masoomeh Shirzaiy
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
Shirzaiy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Zahedan University of Medical Sciences
Full name of responsible person
Mohammadreza Shahraki
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
Shirzaiy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Zahedan University of Medical Sciences
Proportion provided by this source
10
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
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Shirzaiy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
Shirzaiy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Shirzaiy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
Shirzaiy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Masoomeh Shirzaiy
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Phone
+98 54 3344 1824
Email
Shirzaiy@gmail.com
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
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
manuscript
When the data will become available and for how long
2 year
To whom data/document is available
researcher
Under which criteria data/document could be used
treatment
From where data/document is obtainable
internal site
What processes are involved for a request to access data/document