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Evaluation of effect of orabase containing portulaca extract in recurrent aphthous stomatitis treatment

Protocol summary

Study aim
the effectiveness of orabase containing portulaca extract formulation in the treatment of patients with recurrent aphthous
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 orabase containing portulaca extract 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. orabase containing portulaca extract user 2. control placebo user 3. cortichosteroid user
Main outcome variables
the effect of orabase containing portulaca extract consumption on recurrent aphthous stomatitis treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191012045067N4
Registration date: 2021-12-02, 1400/09/11
Registration timing: registered_while_recruiting

Last update: 2021-12-02, 1400/09/11
Update count: 0
Registration date
2021-12-02, 1400/09/11
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
2021-10-23, 1400/08/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of orabase containing portulaca extract in recurrent aphthous stomatitis treatment
Public title
effect of orabase containing portulaca extract in recurrent minor aphthea 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
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant and analyzer do not know about the type of consumables and The drug container is available to the analyzer and the participant in bottles with the same shape and color and is numbered with codes 1 and 2
Placebo
Used
Assignment
Parallel
Other design features
effectiveness of mouth wash containing orabase containing portulaca extract formulation in the treatment of patients with recurrent aphthous stomatitis

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Science
Street address
Azadegan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817699693
Approval date
2021-10-03, 1400/07/11
Ethics committee reference number
IR.ZAUMS.REC.1400.208

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: People with recurrent aphthous ulcer useorabase containing portulaca extract 4 times a day for 5 days (The patient asked to use the orabase containing portulaca extract 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: People with recurrent aphthous ulcer use placebo 4 times a day for 5 days (The patient asked to use the orabase 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: 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
آزادگان
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
search
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