Evaluation of the effect of caffeic acid on recurrent aphthous stomatitis improvement
Design
This clinical trial have two parallel group randomised with blinded postoperetive care and with four block which have 2 patients of control and two patients of intervention group with the using of this site:
ww.sealedenvelope.com/simple/randomise/v1/lists
Settings and conduct
Patients who suffering from aphthous and attend dental school, receiving a bottle of 21 caffeic acid mucoadhesive tablets. They should topically use them after each meal like morning, middle of the day and night. It is good to avoiding drinking or eating after using each tablet till one hour for better absoption.
Participants/Inclusion and exclusion criteria
Patients which suffering from recurrent aphthous stomatitis who are in the range of 20 to 40 years old and having aphthous minor ulcer in lips and mucobuccal area.
Intervention groups
In intervention group which receive mucoadhesive tablet containing caffeic acid, tablet is using topically on aphthous and towards releasing of it, it absorpts the mucosa. 25 patient are belong to this group. In control group patients receiving tablets which they are lack of caffeic acid.
25 patients individually will receive 21 tablets which are in the bottle. 21 tablets are for 7 days which every day morning, after lunch and afternoon should use them( totally 3 tablets for one day)
Main outcome variables
Severity of pain- amount of inflammation by using of diameter of erythematous layer around aphthous and number of days which healing occur
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220815055700N1
Registration date:2022-09-03, 1401/06/12
Registration timing:prospective
Last update:2022-09-03, 1401/06/12
Update count:0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Maede Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 4134
Email address
salehimaede1165@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-17, 1401/06/26
Expected recruitment end date
2022-10-21, 1401/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of caffeic acid on recurrent aphthous stomatitis improvement
Public title
evaluation of the effect of caffeic acid on recurrent aphthous stomatitis improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being infected to minor stomatitis aphthous type
age range 20 to 40
having aphthous ulcer in lips and buccal area of the mouth
having sufficient knowledge for understanding the testimonial
Exclusion criteria:
being infected to major or herpeti form
having aphthous ulcer in other area except lips and buccal
having systemic disease
using immunosuppressive drugs
having denture
pregnant
disease which having syndromes such as behcet's disease
patients who smoke
patient who cannot fill their testimonial
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to categorize samples into two groups we use randomize blocks method. Blocks will be consider as 4 ( which in each group we have 2 patients of placebo and 2 patients of intervention). Selection the name of each group is according to this site:
www.sealenvelope.com/simple-randomise/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
Caffeic acid tablets for patients in exact similar bottle with a numeric code that provided by pharmaceutics department of pharmacy school of medical university of Mazandaran
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Khazar square
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-08-12, 1401/05/21
Ethics committee reference number
IR.MAZUMS..REC.1401.14404
Health conditions studied
1
Description of health condition studied
Minor recurrent stomatitis aphthous
ICD-10 code
Recurrent
ICD-10 code description
K12.0
Primary outcomes
1
Description
Pain and inflammation
Timepoint
0 ,3,5 and 7 days after
Method of measurement
Visual analog scale for pain and diameter of erythematosus around aphthous due to inّflammation
Secondary outcomes
1
Description
Duration of having aphthous
Timepoint
After 7 days
Method of measurement
Visual Analog Scale and dimeter of erythematosus
Intervention groups
1
Description
Intervention group: receiving mucoadhesive tablet which contain Caffeic acid
Category
Treatment - Drugs
2
Description
Control group: receiving mucoadhesive tablet which not contain any amount of Caffeic acid
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba dental clinic(dental school of Mazandaran)
Full name of responsible person
Maede Salehi
Street address
Khazar Blvd.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 0003
Email
salehimaede1165@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnezhad
Street address
Tahghighar and Fanavari Institute- Shahid Motahari Square- Moallem St
City
Sari
Province
Mazandaran
Postal code
481573397
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
Pedrahimnejad@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
دکتر مائده صالحی
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tube dental clinic-Khazar Blvd-Khazar square
City
Sari
Province
Mazandaran
Postal code
481533971
Phone
+98 11 3324 0002
Email
salehimaede1165@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Maede Salehi
Position
َAssociate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd-Khazar Square
City
Sari
Province
Mazandaran
Postal code
481533971
Phone
+98 11 3324 0002
Email
salehimaede1165@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Maede Salehi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd- Khazar Square
City
Sari
Province
Mazandaran
Postal code
481533971
Phone
+98 11 3324 0002
Email
salehimaede1165@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
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