Comparison of Achillea Millefolium with Triamcinolone Acetonide Mucoadhesive Film Effects in Treating the Symptoms and Reducing Period of Recurrent Minor Aphthous Stomatitis
application of yarrow mucoadhesive film and triamcinolone mucoadhesive film to improve symptoms and reduce the duration of minor aphthous lesions and comparing two films
Design
Randomized, double-blind, randomized clinical trial on 60 patients using random allocation service software.
Settings and conduct
Department of oral and dental disease
medical university of isfahan dentistry faculty
double blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients in the age group of 16 to 50 years with a minor aphthous lesion who has been diagnosed by an oral pathologist. Less than 48 hours after the onset of the pest
Exclusion criteria: pregnancy and lactation, concomitant treatment with another drug, allergy to herbs or triamcinolone, immunodeficiency, as well as current or past head and neck radiotherapy and current chemotherapy, neuropsychiatric disorders and lack of cooperation, consumers Systemic steroid drugs, immune regulators and nonsteroidal anti-inflammatory drugs, patients with a history of ulcerative colitis, Behcet's disease, severe anemia and Crohn's disease.
Intervention groups
Intervention group 1: Yarrow mucoadhesive film is applied on aphthous lesion every day after each meal and before bedtime (4 times daily).
Intervention group 2: Triamcinolone acetonide mucoadhesive film is applied to aphthous lesion daily after each meal and before bedtime (4 times daily).
Main outcome variables
the pain
The size of the aphthous lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200303046685N3
Registration date:2022-04-11, 1401/01/22
Registration timing:retrospective
Last update:2022-04-11, 1401/01/22
Update count:0
Registration date
2022-04-11, 1401/01/22
Registrant information
Name
Fahimeh Pakravan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3436 8793
Email address
pakravan@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Achillea Millefolium with Triamcinolone Acetonide Mucoadhesive Film Effects in Treating the Symptoms and Reducing Period of Recurrent Minor Aphthous Stomatitis
Public title
Comparison of Adhesive Pharmacological Form of Achillea Millefolium with Triamcinolone Acetonide Effects in Treating the Symptoms and Reducing Period of Recurrent Aphthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients in the age group of 16 to 50 years with a minor oral stomititis that has been diagnosed by an oral disease specialist.
No more than 24 hours after the onset of the minor oral stomatitis.
Exclusion criteria:
Pregnancy and lactation
concomitant treatment with other drugs
allergy to herbs or triamcinolone
immunodeficiency
current and past head and neck radiotherapy and current chemotherapy
neuropsychiatric disorders and lack of cooperation
systemic steroid, Immune regulators and non-steroidal anti-inflammatory drugs users
Patients with a history of ulcerative colitis
Behcet's disease, severe anemia and Crohn's disease
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Among patients suffering from minor aphthous stomatitis who refereed to dentistry department of isfahan medical univeristy, 60patients who have been examined by supervisor and have met the eligibility criteria, will enter the study and a number will be assigned to every patient. Then they will be divided into two intervention groups using block randomization (block size=30) through the random allocation service software. For allocation concealment, sealed coded boxes with randomized sequence with the same size and weight will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the participant and the investigator are not aware of the administered medication because of the similarity of the films In appearance, color and smell provided to the participants.
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
Hezarjerib Ave, Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.275
Health conditions studied
1
Description of health condition studied
Recurrent minor Aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
pain
Timepoint
Days two, four and six of the study
Method of measurement
VAS ( visual analogue scale)
2
Description
The size of the aphthous lesion
Timepoint
Days two, four and six of the study
Method of measurement
ruler (millimeter)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Achillea millefolium adhesive film, every day after every meal and before bed, the duration of treatment for a week or until the lesions heal, whichever occurs sooner
Category
Treatment - Drugs
2
Description
second intervention group: : Triamcinolone acetonide adhesive film with 1mg active ingredient, made by Dr Saniee Pharmaceutical Company, every day after every meal and before bed, the duration of treatment for a week or until the lesions heal, whichever occurs sooner
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Diseases, Isfahan School of Dentistry
Full name of responsible person
Fahimeh Pakravan
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3436 8793
Email
pakravan@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansoor Siavash
Street address
Department of Oral Medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3436 8793
Email
pakravan@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
Fahimeh Pakravan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3436 8793
Email
pakravan@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral medicine
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3792 5515
Email
Pakravan@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral medicine
Street address
Department of oral medicine Faculty of Dentistry; Isfahan University of Medical Sciences; Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3792 5515
Email
Pakravan@dnt.mui.ac.ir
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
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only information such as main consequence or the like can be shared.
When the data will become available and for how long
Access to the results immediately after publication
To whom data/document is available
Open access
Under which criteria data/document could be used
Access to data is possible only after formal permission from corresponding author
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document