Protocol summary

Study aim
Evaluation of the effectiveness of Zinc Sulfate mucoadhesive tablet in the improvement of Recurrent Aphthous Stomatitis (RAS)
Design
The randomized 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
Including criteria: Individuals with adequate knowledge and literacy, age group 16 to 45 years old, Aphthous diagnostic criteria and ability to fill out the consent form legally. Excluding criteria: Individuals with major recurrent aphthous stomatitis and herpetic form, aphthous ulcers other than labial and buccal sites, systemic disease, consuming immunosuppressive drug, using denture, consuming antibiotics, pregnancy, poor oral hygiene, unable to receive Zinc sulfate mucoadhesive tablet, in syndromes which Aphthous ulcers are one of the manifestations, like Behcet's syndrome, Individuals who are prescribed a non-Zinc drug for Aphthous improvement, Smoking.
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: IRCT20151109024975N9
Registration date: 2018-08-01, 1397/05/10
Registration timing: retrospective

Last update: 2018-08-01, 1397/05/10
Update count: 0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Gohar Eslami
Name of organization / entity
Mazandaran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3695
Email address
g.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2018-01-28, 1396/11/08
Actual recruitment end date
2018-05-26, 1397/03/05
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Zinc Sulfate mucoadhesive tablet in the improvement of Recurrent Aphthous Stomatitis (RAS)
Public title
Effect of Zinc in improvement of Aphthous
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with adequate knowledge and literacy Age group is 16 to 45 years old Aphthous diagnostic criteria Ability to fill out the consent form legally
Exclusion criteria:
Individuals with major recurrent aphthous stomatitis & herpetic form Patients who had aphthous lesions in other areas than Labial & Buccal mucosa Patients with systemic disease during last month Patients with Denture Patients consuming antibiotics Patients with pregnancy Individuals with poor oral hygiene Individuals who are not capable of receiving Zinc sulfate mucoadhesive Individuals who have syndromes which Aphthous ulcers are one the manifestations, like Behcet's syndrome Individuals who are prescribed a non-Zinc drug for Aphthous improvement Smoking Individuals Individuals who consume Immunosuppressive drug during last month Individuals who couldn't resume the study according to social or personal issues
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
Actual sample size reached: 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 of drugs and they are quite similar.
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
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2018-04-24, 1397/02/04
Ethics committee reference number
IR.MAZUMS.REC.1397.004

Health conditions studied

1

Description of health condition studied
Recurrent Aphthous Stomoatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae

Primary outcomes

1

Description
Diameter of eritmathous halo
Timepoint
Zero (before entering the study); third; fifth and seventh days
Method of measurement
Metal caliber

Secondary outcomes

1

Description
Period of improvement
Timepoint
Zero (before entering the study); third; fifth and seventh days
Method of measurement
Visual Analogue Scale Questionnaire

Intervention groups

1

Description
Intervention group: Patients received mucoadhesive tablets three times a day containing Zinc Sulfate (morning, afternoon and night). How to use the mucoadhesive tablets was taught to patients so that they should avoid eating and drinking for 30 minutes after applying the tablet. The chemical composition of the Zinc Sulfate mucoadhesive tablets tablet: A certain amount of Zinc Sulfate 8H20 (containing 5 mg of Zinc) was selected as a therapeutic dose to evaluate the effects of this substance on the improvement of oral Aphthous. Other components include Carbopol 940 and Sodium Alginate as a tablet binding agent to the mucus, starch as a filler to the body of the tablet, and sucrose to create the proper taste and help the pill to open gradually in the mouth.
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 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
Anahita Ghorbani
Street address
Vali;Asr highway
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4001
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
+98 11 3304 4001
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
+98 11 3304 4001
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
+98 11 3304 4001
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
Begining the access period is 12 months after printing the results.
To whom data/document is available
Only available to scholars working in academia and scientific institutes.
Under which criteria data/document could be used
It is allowed any kind of analysis, after receiving the results.
From where data/document is obtainable
Dr. Anahia Ghorbani; Oral & Maxillofacial Diagnostic section; Sari Dentistry Faculty; 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.
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