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Evaluation of the effectiveness of mallow extract mucous adhesive on recurrent aphthous stomatitis

Protocol summary

Study aim
Determining the effectiveness of mallow extract mucous adhesive in treatment of recurrent aphthous stomatitis
Design
Control group: Placebo. Intervention group: Mallow extract mucous adhesive. Randomized double blind clinical trial. 21 patients in each group.
Settings and conduct
The patients in the study will be divided into two groups. In the first group, the patients will be given 3 pieces of mucus glue daily so that they use it in the morning, noon and night. Patients are taught how to use the adhesive mucus so that they should avoid eating and drinking for 30 minutes after using it. In the control group, the same operation will be done with a placebo. In order to evaluate the level of pain and healing of the lesions, the patients are clinically examined on days zero (before entering the study) 3/5/7 using a metal caliper to determine the diameter of the lesions and the inflammatory area around them. The patients are also taught It is given to determine the intensity of pain based on the VAS criterion.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with minor recurrent stomatitis, patients with aphthous lesions on the lips and buccal mucosa, not suffering from systemic disease, not taking immunosuppressive drugs in the past month, not using dentures, not taking antibiotics. Exclusion criteria: pregnant patients, people who are not able to use mucous adhesive, people with syndromes whose manifestations are aphthous ulcers (Behcet's syndrome) , smokers, people with autoimmune diseases of the skin, mucosa , patients with Liver failure, myopathy and muscle problems, patients suffering from allergies and urticaria, and people who cannot continue the study due to personal and social reasons.
Intervention groups
Control group: Placebo. Intervention group: Mallow extract mucous adhesive.
Main outcome variables
Pain and diameter of the lesion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170430033722N5
Registration date: 2023-08-09, 1402/05/18
Registration timing: retrospective

Last update: 2023-08-09, 1402/05/18
Update count: 0
Registration date
2023-08-09, 1402/05/18
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
2023-04-05, 1402/01/16
Expected recruitment end date
2023-06-06, 1402/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of mallow extract mucous adhesive on recurrent aphthous stomatitis
Public title
Evaluation of the effect of mallow on oral aphthous
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with minor recurrent stomatitis Patients who have aphthous lesions in the lips and buccal mucosa Absence of systemic disease Not taking immunosuppressive drugs in the last 1 month Not using dentures No use of antibiotics
Exclusion criteria:
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: 42
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be randomly assigned to two groups. Blocks will be considered as quadruplets (two subjects will be placed in each group in each block).
Blinding (investigator's opinion)
Double blinded
Blinding description
randomized double blind clinical trial The patient and the evaluator do not know the type of study group
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
Moallem square, Deputy of Research and Technology building
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2017-06-13, 1396/03/23
Ethics committee reference number
IR.MAZUMS.REC.1396.2863

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 level of pain and healing of recurrent aphthous lesions
Timepoint
Days of 0 (beginning of the study), 3, 5, and 7
Method of measurement
Determining the diameter of lesions using a metal caliper and measuring the intensity of pain using a visual analog scale (VAS).

Secondary outcomes

empty

Intervention groups

1

Description
Control group: receives a placebo
Category
Treatment - Drugs

2

Description
Intervention group: 3 pieces of adhesive mucus containing mallow extract with a concentration of 10% will be given daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Touba dental clinic
Full name of responsible person
Tahereh Molania
Street address
Khazar Blvd, Touba dental clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
t_molania117@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahim Nejad
Street address
MoalLem Square, Research and Technology Deputy Building
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Fax
Email
pajhooheshi@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
Tahereh Molania
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Touba dental clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
t_molania117@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tahereh Molania
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd - Touba dental clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 912 616 1528
Fax
Email
t_molania117@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tahereh Molania
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Blvd, Touba dental clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 912 616 1528
Email
t_molania117@yahoo.com

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Apart from the identity data of the study participants, other information will be provided to the applicant upon request from the corresponding author of the article.
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
everyone
Under which criteria data/document could be used
The applicant can email the corresponding author of the article and request for information.
From where data/document is obtainable
Corresponding author of the article
What processes are involved for a request to access data/document
The applicant can email the corresponding author of the article and request for information.
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