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Assessment of Atorvastatin mucoadhesive effect on minor recurrent aphthous stomatitis

Protocol summary

Study aim
evaluation of effectiveness of atorvastatin-containing mucoadhesive on recurrent aphthous stomatitis
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 3. at first, based on the inclusion criteria, 44 people will be selected by available sampling method.Randomization of this study is done by blocking with random allocation software.Then the patients are divided into two groups such as 22 patients in the intervention group and 22 patients in the control group
Settings and conduct
The study population will be selected from those referring to the Department of Oral medicine, Dental school, Mazandaran University of Medical Sciences in 1400.Patients are asked to visit within the 24 hours after the outbreak. in the intervention group, 3 pieces of mucoadhesives will be given daily for 10 days so that they can use it in the morning, noon and night.Patients should abstain from eating and drinking for 30 minutes.In the control group, the same operation will be done with placebo.In order to assess the amount of pain and the healing, patients are examined on days 0, 3, 5, 7 to determine the size of the lesions and the inflammatory area.Patients also determine the severity of pain by VAS criteria.Participants and the examiner are not aware of the type of mucoadhesive used (atorvastatin or placebo
Participants/Inclusion and exclusion criteria
Patients with recurrent aphthous stomatitis, ranging in age from 20 to 40 years, have all reported a history of minor ulcerations in the lips and buccal mucosa
Intervention groups
The atorvastatin is placed topically on the lesion and it is delivered to the inflamed area for a longer period of time.for comparison, the control group will receive placebo.
Main outcome variables
Atorvastatin-containing adhesive, pain, healing time, wound inflammation

General information

Reason for update
Acronym
RAS
IRCT registration information
IRCT registration number: IRCT20170430033722N4
Registration date: 2021-07-16, 1400/04/25
Registration timing: retrospective

Last update: 2021-07-16, 1400/04/25
Update count: 0
Registration date
2021-07-16, 1400/04/25
Registrant information
Name
Tahereh Molania
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3861
Email address
tmolania@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Atorvastatin mucoadhesive effect on minor recurrent aphthous stomatitis
Public title
Assessment of Atorvastatin mucoadhesive effect on minor recurrent aphthous stomatitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with recurrent aphthous stomatitis showing aphthous lesions in the lips and buccal mucosa No systemic disease Do not take immunosuppressive drugs for the past month Do not use dentures Do not take antibiotics
Exclusion criteria:
Pregnant patients People who are not able to use mucoadhesive People with syndromes in which aphthous ulcers are manifestations (Behjat syndrome) the smokers People with autoimmune mucocutaneus lesions Patients with liver failure, myopathy and muscle problems Patients with allergies, hives and itchy skin and mucous membranes People who can not stay in the study due to personal or social reasons
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be determined by random blocking method with 4 blocks and using the random number table of Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The allocation ratio of the samples will be (Allocation 1: 1) and they will be placed in two groups receiving atorvastatin and placebo mucoadhesives. Drugs will then be given to patients based on the blocks obtained and in the order of allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
participants are not aware of the type of mucoadhesive used the examiner (the person measuring the size of the lesions) is also unaware of the type of mucoadhesive used
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
School of Dentistry, Mazandaran University of Medical Sciences, Sari, Khazar Square, next to Touba Complex
City
sari
Province
Mazandaran
Postal code
4815733971
Approval date
2021-01-05, 1399/10/16
Ethics committee reference number
IR.MAZUMS..REC.1400.8346

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
The size of the erythematous halo around the aphthous lesion
Timepoint
0 (Before intervention) and 3, 5 and 7 days after aphthous lesion
Method of measurement
Metal caliber

2

Description
Patients' pain intensity
Timepoint
0 (Before intervention) and 3, 5 and 7 days after aphthous lesion
Method of measurement
Visual Analog Scale (universal Pain Assessment Tool)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients will be given 3 mucoadhesives containing 10 mg of atorvastatin daily for 10 days to use in the morning, noon and night.This mucoadhesive is made in the laboratory of Sari School of Pharmacy.Patients are instructed in how to use the mucoadhesive so that it should be placed on the wet mucosa of the lesion and they should avoid eating and drinking for up to 30 minutes after use.
Category
Prevention

2

Description
Control group: Patients will be given 3 doses of non-drug adhesive (placebo) daily for 10 days so that they can use it in the morning, noon and night.This mucoadhesive is made in the laboratory of Sari School of Pharmacy.Patients are instructed in how to use the mucoadhesive so that it should be placed on the wet mucosa of the lesion and they should avoid eating and drinking for up to 30 minutes after use.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Clinic, Mazandaran University of Medical Sciences
Full name of responsible person
Dr Tahereh Molania
Street address
Dental clinic, Khazar Blvd, Khazar square Sari Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 4134
Email
t_molania117@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice chancellor for research, The martyr Motahhari square, Street teacher
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3448 4800
Email
SRC@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
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
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
Maede Salehi Sarookolaei
Position
Oral Diseases specialist-Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari dentistry college, Khazar square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 4014
Fax
Email
salehimaede1165@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Tahereh Molania
Position
Expert mouth disease diagnosis / Assistant Professor, Faculty of Dentistry University of Medical Sci
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3330 2908
Fax
Email
T_molania117@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Tahereh Molania
Position
Expert mouth disease diagnosis / Assistant Professor, Faculty of Dentistry University of Medical Sci
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental clinic, Khazar Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3330 2908
Fax
Email
T_molania117@yahoo.com
Web page address

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
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