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The efficacy of Omega 3 in the treatment of recurrent aphthous stomatitis: A randomized parallel controlled trial

Protocol summary

Summary
Recurrent aphthous stomatitis (RAS) is a condition which is marked by painful ulcers that develop on non-keratinized oral mucosa. Omega 3 contains anti inflammatory and analgesic effects. clinical study with double control and placement of patients in the two groups will perform. Of the groups of patients referred to the Department of Oral Medicine, School of Dentistry, Zahedan selected. patients using randomly divided into A and B groups. For patients in group A 1000 mg of omega 3 capsules (made in Iran, drug distribution company) three times daily for 6 months, patients in group B placebo capsules (made of Iran, drug distribution company) three times in the same day Omega 3 and 6 months is recommended. The questionnaire for each patient, including age, sex, occupation, medical history, status and the number and size of wounds, disease duration, recurrence intervals, the pain of ulcers, previous treatments performed and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041620377N2
Registration date: 2015-05-26, 1394/03/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-26, 1394/03/05
Registrant information
Name
Tahereh Nosratzehi
Name of organization / entity
Dental School of Zahedan University
Country
Iran (Islamic Republic of)
Phone
+98 915 348 0151
Email address
nosratzehi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-04-15, 1394/01/26
Expected recruitment end date
2016-04-14, 1395/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Omega 3 in the treatment of recurrent aphthous stomatitis: A randomized parallel controlled trial
Public title
The efficacy of Omega 3 in the treatment of recurrent aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: More than four days since the beginning aphthous ulcers they not passed; Before go for treatment of aphthous lesions are not using; Patients must agree to cooperate with the project (Moral satisfaction). Exclusion criteria: Another solution is to use the drug for the treatment of pests; Not recommended to use the drug according to patient; Not referring a patient for re- examination; Pregnant women; systemic disease and drug use
Age
From 13 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Stratified Blocking

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Postal code
9811111111
Approval date
2015-04-14, 1394/01/25
Ethics committee reference number
1438

Health conditions studied

1

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

Primary outcomes

1

Description
Ulser Size
Timepoint
On days 0، 2، 4، 6، 10، 14
Method of measurement
Caliper

2

Description
Number of Ulcer
Timepoint
On days 0، 2، 4، 6، 10 ،14
Method of measurement
counts Of Ulcers

Secondary outcomes

1

Description
level of pain
Timepoint
On days 0، 2، 4، 6، 10، 14
Method of measurement
Visual Analogue Scale

2

Description
level of Burning
Timepoint
On days 0، 2، 4، 6، 10، 14
Method of measurement
Visual Analogue Scale

3

Description
Recurrence of Lesion
Timepoint
The first week, second week, first month of the third, fourth month, Fifth Month, Sixth Month
Method of measurement
Clinical Examination

Intervention groups

1

Description
Intervention group: 1000 mg capsule omega 3 (made of Iran, drug distribution company) three times per days for 6 months
Category
Prevention

2

Description
Control group: 1000 mg capsule placebo (made of Iran, drug distribution company) three times per days for 6 months
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan University Of Medical Sciences
Full name of responsible person
Dr Tahereh Nosratzehi
Street address
Oral medicine department, faculty of dentistry, Azadegan street, Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Tahereh Nostatzehi
Street address
Oral medicine department, faculty of dentistry, Azadegan street, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Tahereh Nostatzehi
Position
Assistant Professer Zahedan University of Medical Sicences
Other areas of specialty/work
Street address
Oral medicine department, faculty of dentistry, Azadegan street, Zahedan
City
Zahedan
Postal code
9811111111
Phone
+98 54 3328 7991
Fax
+98 11111111
Email
nosratzehi@zaums.ac.ir ; nosratzehi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Tahereh Nosratzehi
Position
Assistant Professer of Zahedan University of Medical Sicences
Other areas of specialty/work
Street address
Oral medicine department, faculty of dentistry, Azadegan street, Zahedan
City
Zahedan
Postal code
9811111111
Phone
+98 54 3328 7991
Fax
+98 11111111
Email
nosratzehi@zaums.ac.ir ; nosratzehi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Tahereh nosratzehi
Position
Assistant Professer of Zahedan University of Medical Sicences
Other areas of specialty/work
Street address
Oral medicine department, faculty of dentistry, Azadegan street, Zahedan
City
Zahedan
Postal code
9811111111
Phone
+98 54 3328 7991
Fax
+98 911 111 111
Email
nosratzehi@zaums.ac.ir ; nosratzehi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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