Determining and comparing the effect of different doses of ANCIL solution on pain intensity and recovery time of recurrent aphthous stomatitis
Design
Due to the lack of previous studies in this field and the pilot nature of the present study, using the study of Amy L Whitehead et al. And considering the average effect size, 20 people in each group will be considered (total sample size 80 people)
Settings and conduct
This study is a double-blind, placebo-randomized study using ANCIL solution or placebo in people with symptomatic oral aphthous. Subjects are randomly assigned to intervention and control groups. Patients referred to Imam Reza Hospital of Tabriz University of Medical Sciences with signs and symptoms related to oral plague through the entry/exit criteria and with informed written consent are included in the study or removed from it.
Participants/Inclusion and exclusion criteria
Patients with minor and solitary aphthous ulcers in the cheek and lip mucosa of both sexes in the age range of 18 to 40 years are included in this study. In this study, pregnant, lactating, systemic patients with herpetiform ulcers and major aphthous ulcers Or multiple minor for more than 4 days and patients who refuse to participate in the study are excluded from the study
Intervention groups
Intervention group1:20 patients with oral aphthous receive a solution of ANCIL at a dose of 0.5 twice a day/Intervention group2: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 1 twice a day/Intervention group3: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 2 twice a day
Control group: 20patients with oral aphthous Treating in a way other than the mentioned procedure
Main outcome variables
Comparison of different doses of ANCIL solution on the recovery time and pain intensity of recurrent oral aphthous
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190701044062N6
Registration date:2021-06-26, 1400/04/05
Registration timing:prospective
Last update:2021-06-26, 1400/04/05
Update count:0
Registration date
2021-06-26, 1400/04/05
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ANSIL(Silver nanoparticles) to improve recurrent aphthous stomatitis: a double-blind clinical trial
Public title
Effect of ANSIL on the aphthous
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minor and solitary aphthous ulcers in the lip mucosa or cheek
Age range 18 to 40 years
Exclusion criteria:
Pregnant
Breastfeeding
Patients with systemic disease
Patients with herpetiform ulcers and multiple major or minor aphthous ulcers for more than 4 days
Patients who refuse to participate in the study
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using simple randomization using GraphPad software and by a secretary who does not interfere with other stages of the investigation.
Blinding will be done by labeling the ointments as A, B, C, D that a person who is aware of the contents of each ointment is not present in other stages of the research and after statistical analysis of the contents of the ointment will be obtained.
Blinding (investigator's opinion)
Double blinded
Blinding description
A solution that has an active ingredient in ANCIL with a solution that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the solution used for the patient may be medication or medication. Clinicians or outcome assessors and blind patients will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medic
Street address
Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.TBZMED.REC.1400.179
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
Comparison of different doses of ANCIL and placebo solution on the recovery time of recurrent oral aphthous
Timepoint
80 patients will be divided into 4 groups of 20 and 3 groups of patients will receive doses of 0.5, 1, and 2 ANCIL solution. The fourth group will receive the basic formulation of the solution without active components. The duration of use of the solutions will be a maximum of 7 days. Then the duration of complete recovery of the oral aphthous in the groups will be compared.
Method of measurement
Different doses are compared based on the patient's clinical symptoms and observing the speed of oral aphthous recovery
2
Description
Pain intensity in patients with recurrent oral aphthous
Timepoint
On days 0, 5 and 7
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:20 patients with oral aphthous receive a solution of ANCIL at a dose of 0.5 twice a day
Category
Treatment - Drugs
2
Description
Intervention group: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 1 twice a day
Category
Treatment - Drugs
3
Description
Intervention group: 20 patients with oral aphthous receive a solution of ANCIL at a dose of 2 twice a day
Category
Treatment - Drugs
4
Description
Control group: 20patients with oral aphthous Treating in a way other than the mentioned procedure
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz
Full name of responsible person
Manouchehr Khoshbaten
Street address
Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
reasearch-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Yousefipour
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
City
Tabriz
Province
East Azarbaijan
Postal code
5158375751
Phone
+98 41 3662 8155
Email
ali_you_2015@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Yousefipour
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No1026,East Second floor, Azarabadegan Ave, Third daneshgah Ave, Nasr Town
City
Tabriz
Province
East Azarbaijan
Postal code
5158375751
Phone
0416628155
Email
ali_you_2015@yahoo.co.uk
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data will be shared.
When the data will become available and for how long
2023-2024
To whom data/document is available
Researchers and academic staffs
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Request via email
What processes are involved for a request to access data/document