Comparison of effectiveness of the bioadhesive pastes curcumin and topical corticosteroid for the treatment of Aphthous Stomatitiss
Design
Clinical trials with parallel , double -blind, randomized groups
Settings and conduct
This study will be performed on all patients referred to the the School of Dentistry of Zahedan University in 2021, whose diagnosis of minor oral aphthous in their oral mucosa has been confirmed. Sampling will be done based on inclusion and exclusion criteria and for each treatment group, 30 samples and a total of 60 samples will be considered.
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Patients with RAS with duration of 1 day of begining of their symtoms Exit criteria: 1. Use of systemic Aphthous treatment (over the past three months) and topical treatment during the procedure 2. Atypical Aphthous cases and cases suspected of Behcet's syndrome, inflammatory bowel disease, and ... 3. Pregnant or lactating women 4. Patient with Diabetes 5. High blood pressure 6. Duration of the Aphthous more than one day 7. The patients who did not sign the letter of informed consen
Intervention groups
first group administration of Curcumin; second group administration of Adcotryl on oral aphtous lesions and evaluation of the severity of pain, size of the wound and the recovery time before and after administration.
Main outcome variables
Evaluation of pain and burning symptoms and size of ulcer present in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141220020377N5
Registration date:2021-10-02, 1400/07/10
Registration timing:registered_while_recruiting
Last update:2021-10-02, 1400/07/10
Update count:0
Registration date
2021-10-02, 1400/07/10
Registrant information
Name
Tahereh Nosratzehi
Name of organization / entity
Dental School of Zahedan University
Country
Iran (Islamic Republic of)
Phone
+98 915 348 0151
Email address
nosratzehi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-09, 1400/06/18
Expected recruitment end date
2022-06-12, 1401/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of the bioadhesive pastes curcumin and topical corticosteroid for the treatment of Aphthous Stomatitis
Public title
Comparison of effectiveness of the bioadhesive pastes curcumin and topical corticosteroid for the treatment of Aphthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with RAS symptoms for less than 1 day
Exclusion criteria:
The patients who did not sign the letter of informed consent
Patient with hypertension (greater than 80/130)
cases suspected of Behcet's syndrome, inflammatory bowel disease.
Pregnant or lactating women
Patients with Diabetes Patients
Use of systemic aphthous treatment (over the past three months) and topical treatment during the procedure Atypical aphthous cases
Patients with RAS symptoms for more than 1 day
Age
From 12 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected by available and non-probabilistic methods and from among them, patients who meet the inclusion criteria will be selected. Then patients will be divided into two groups of control and intervention by simple random method (code is assigned to each sample) and using SPSS statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
How to use each drug was typed in a container containing an anonymous drug, in an opaque envelope. Each envelope was given to the patient at random. The name of the drug was specified as A and B and was written in the questionnaire on which the test results of the patients were recorded by the researcher. So that it can be analyzed only by the statistics consultant at the end of the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Research Vice Chacellorship of Zahedan University of Medical Sciences
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745534
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.ZAUMS.REC.1399.489
Health conditions studied
1
Description of health condition studied
Recurrent oral aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
pain sensation
Timepoint
before starting study,days 1,4 ,7 ,10
Method of measurement
Use of visual analoge scale (VAS) from 0- 10, 0: no pain
Secondary outcomes
1
Description
Recurrent aphthous ulcers
Timepoint
days 1,4,7,10
Method of measurement
Measuring of ulcers by ruler
Intervention groups
1
Description
Control: Triamcinolone in oral base Ointment (Triadent), topical use in oral mucosa ulcer, 3 time/day, after meal, for 10 days
Category
Treatment - Drugs
2
Description
Intervention: Curcumin Gel-topical use in oral mucosa ulcer, 3 time/day, after meal for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University Of Medical Sciences
Full name of responsible person
Tahereh Nosratzehi
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981675534
Phone
+98 54 3411 3041
Email
Nosratzehim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor mohammadBakhshani
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981675534
Phone
+98 54 3411 3041
Email
Nosratzehim@yahoo.com
Grant name
Research Vice Chacellorship of Zahedan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Tahereh Nosratzehi
Position
Associated Professer , Department of Oral Medicine, Dental Research Center, Zahedan University Of Me
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981675534
Phone
+98 54 3411 3041
Email
Nosratzehim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Tahereh Nosratzehi
Position
Associated Professer , Department of Oral Medicine, Dental Re
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981655534
Phone
+98 54 3411 3041
Email
Nosratzehim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Tahereh Nosratzehi
Position
Associated Professer , Department of Oral Medicine, Dental Re
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981675534
Phone
+98 54 3411 3041
Email
Nosratzehim@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
Title and more details about the data/document
No- There is no plan to make this available at the present time
When the data will become available and for how long
starting 10 months after publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
It is permitted to use the data in other studies with reference.
From where data/document is obtainable
Nosratzehi@zaums.ac.ir
What processes are involved for a request to access data/document