Evaluation of the effectiveness of N-acetylcysteine mucosa adhesive in comparison with placebo on recurrent aphthous stomatitis (RAS) in the specific age group 16-45 years old
Evaluation of the effectiveness of N-acetylcysteine mucosa adhesive in comparison with placebo on recurrent aphthous stomatitis (RAS)
Design
The nonrandomized clinical trial with the intervention and control group, parallel groups, double-blinded
Settings and conduct
This study is a double; blinded clinical trial which was performed at Sari, Faculty of Dentistry Clinic.
Participants/Inclusion and exclusion criteria
Entry criteria: Age group 16-45, and aphthous diagnostic criteria and legally able to fill out their the consent form. Excluding criteria: Individuals with major recurrent aphthous stomatitis and herpetic form, people with systemic diseases, denture users, people taking immunosuppressive drugs, antibiotic recipients, people with low levels of health, pregnant patients, people who use other drugs to treat aphthous ulcer, in syndromes which Aphthous ulcers are one of the manifestations, like Behcet's syndrome, smokers.
Intervention groups
In the intervention group, the mucoadhesive tablet was given 3 times a day (morning, noon, and night). In the control group, the same was done with a placebo.
Main outcome variables
Eritmathous halo; improvement period; pain
General information
Reason for update
Acronym
RAS
IRCT registration information
IRCT registration number:IRCT20180728040614N1
Registration date:2018-09-29, 1397/07/07
Registration timing:registered_while_recruiting
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Anahita Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3330 0300
Email address
a.ghorbani1@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of N-acetylcysteine mucosa adhesive in comparison with placebo on recurrent aphthous stomatitis (RAS) in the specific age group 16-45 years old
Public title
Effect of N-acetylcysteine in the improvement of Aphthous
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 16 to 45 years old
Diagnostic criteria for aphthous stomatitis
sufficient knowledge to understand the description provided for treatment
Legally the patients are able to complete their consent form
Exclusion criteria:
People who take suppressive drugs during the past month
People with Systemic Disease
People with syndromes such as Behcet's syndrome, which aphthous ulcer is one of the manifestations .
Patients who develop aphthous ulcers in areas other than labial and buccal mucosa
People with recurrent stomatitis Herpes form
People with recurrent major aphthous stomatitis
Patients with poor oral hygiene
Pregnant women
Antibiotic users
Patients with dentures
People who use other drugs to treat aphthous ulcer and in general people who cant stay or cant continue cooperation till end of research due to personal and social reasons
Smoking Individuals
Age
From 16 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner is unaware of the contents of the boxes and the boxes of medications are quite similar.
Placebo
Used
Assignment
Parallel
Other design features
The present study is a double-blinded clinical trial study. The examiner is unaware of the contents of the boxes and the boxes of medications are quite similar. Patients present in the study will be divided into two groups. In the first group, patients will receive 3 times daily mucosa adhesive tablets, so that they will use morning, afternoon and night. How to use a mucous adhesive tablet is taught to patients, which drinking and eating should be avoided for 30 minutes when mucosa adhesive tablet applied to the area with an aphthous ulcer. In the control group, the same is done with placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2018-08-25, 1397/06/03
Ethics committee reference number
IR.MAZUMS.REC.1397.2955
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
Diameter of eritmathous halo
Timepoint
Days zero (before entering the study); third; fifth and seventh
Method of measurement
Metal caliber
2
Description
Period of improvement
Timepoint
Days zero (before entering the study); third; fifth and seventh
Method of measurement
Visual Analogue Scale Questionnaire
Secondary outcomes
1
Description
The amount of pain
Timepoint
Days zero (before entering the study); third; fifth and seventh
Method of measurement
Visual Analogue Scale Questionnaire
Intervention groups
1
Description
Intervention group: Patients received mucoadhesive tablets three times a day containing N-acetylcysteine (morning, afternoon and night). How to use a mucoadhesive tablet was taught to the patients, which drinking and eating must be avoided for 30 minutes after application. The chemical composition of the mucoadhesive tablet: 25 mg of NAC was selected as the appropriate treatment dose to evaluate the effects of this substance on the accelerated improvement of mouth ulcer. Other components of the tablet include Carbopol 940 and sodium alginate as a binding agent to the oral mucosa, starch to adjust the weight of the tablet, also to adjust the disintegrant time, and sucrose to make the taste. The components of the formulation were passed through a mesh of 80 (No. 80) and mixed together. Then they were pressed with a single-pill tablet press.
Category
Treatment - Drugs
2
Description
Control group: : Patients received mucoadhesive tablets three times a day containing Placebo (morning, afternoon and night). How to use the mucoadhesive tablets was taught to the patients so that they should avoid eating and drinking for 30 minutes after applying the tablet.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sari Faculty of Dentistry clinic
Full name of responsible person
Anahita Ghorbani
Street address
Khazar boulevard
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3340 5474
Email
anahita1802@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 4001 3304
Email
anahita1802@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
90
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
Anahita Ghorbani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
0098_114001 3304
Email
anahita1802@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Anahita Ghorbani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
0098_114001 3304
Email
anahita1802@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Anahita Ghorbani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
0098_114001 3304
Email
anahita1802@yahoo.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
Not applicable
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Sharing the information on the main consequence is possible.
When the data will become available and for how long
Start of the access period 12 months after publishing the results
To whom data/document is available
Only available to scholars working in academic and scientific institutes.
Under which criteria data/document could be used
After receiving the results. any kind of analysis is allowed.
From where data/document is obtainable
Dr. Anahia Ghorbani; Faculty of Dentistry;Oral Diagnostic section ; Khazar Blvd; Khazar Sq; Sari
What processes are involved for a request to access data/document
First, send an email to the response officer. The applicant will be contacted after the necessary investigations