The main reason for treating recurrent aphthous stomatitis (RAS) is to relieve pain and reduce the frequency of recurrences. The aim of this study is to assess the effect of mucoadhesive paste of pomegranate on recurrent aphthous ulcerations.
Materials and Methods: Pomegranate juice is prepared by machine and 5% dried concentration will then added to the paste base. The study is a blind clinical trial. Forty-six patients with RAS formed the study group and will examined according to pre-established criteria. The patients will put into two groups. One group receive paste with drug and the other one receive mucoadhesive paste without drug. The patients applied the paste three times a day from the first premonitory signs of RAS appearance. All the patients were examined on Days 0, 1, 6 and 10. The large diameter of the wound will measure and record by a periodontal probe. Pain intensity will also calculate using VAS scores. The subjects will asked to record the intensity of pain every day.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111823169N2
Registration date:2015-12-03, 1394/09/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-03, 1394/09/12
Registrant information
Name
Negar Salehi
Name of organization / entity
Department of Oral Medicine of Kerman Dental School
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9023
Email address
n.salehi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Dentistry, Kerman University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of mucoadhesive paste of pomegranate on recurrent aphthous stomatitis
Public title
Effect of pomegranate on recurrent aphthous
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: recurrent aphthous stomatitis; recurring ulcers at least two times yearly.
exclusion criteria: traumatic ulcers caused by a sharp tooth, broken restoration, orthodontic appliances or partial dentures; diseases like anemia; abnormal skin lesions; recurrent infections; recurrent genital ulcerations; joint pain; eye problems and vision disturbances such as pain; blurred vision; redness; patients who were using other medicines for the treatment of oral aphthous ulcers; oral lesions for more than three days.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kerman Medical Science university
Street address
Kerman Medical Science Research center, Tahmasbabad squar, Kerman
City
Kerman
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
k/88/187
Health conditions studied
1
Description of health condition studied
Medication for Recurrent oral aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Pain intensity
Timepoint
Everyday for 10 days
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
1
Description
The diameter of the ulcers
Timepoint
The 1st, 6th and 10th days
Method of measurement
Periodontal probe
Intervention groups
1
Description
Intervention: Pomegranate juice from sweet and sour pomegranate was prepared in equal weight ratio using a juicer. Then, the prepared pomegranate juice was dried by freeze-drying and was added to the mucoadhesive paste with 5% concentration and The paste is administered 3 times daily after breakfast, lunch and before bed on the aphthous ulcers
Category
Treatment - Drugs
2
Description
Control group: mucoadhesive paste without additives will prepare and The paste is administered 3 times daily after breakfast, lunch and before bed on the aphthous ulcers
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Medicine, Kerman Dental School
Full name of responsible person
Dr Negar Salehi
Street address
Kerman Dental School,Shafa Av.
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Kerman Dental School
Full name of responsible person
Dr Goli Chamani
Street address
Department of Oral Medicine, Kerman Dental School, Shafa Av.
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Kerman Dental School
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Research Center of Kerman Dental School
Full name of responsible person
Dr Mohamadreza Zarei
Street address
Department of Oral Medicine, Kerman Dental School, Shafa Av.
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Kerman Dental School
Proportion provided by this source
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
Kerman Dental School
Full name of responsible person
Dr Negar Salehi
Position
Oral Medicine Resident
Other areas of specialty/work
Street address
Kerman Dental School, Shafa av.
City
Kerman
Postal code
Phone
00
Fax
Email
debonair_n@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Dr Goli Chamani
Position
Associate Professor of Oral Medicine Department
Other areas of specialty/work
Street address
Kerman Dental School, Shafa av.
City
Kerman
Postal code
Phone
00
Fax
Email
golichamani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Oral Medicine of Kerman Dental School
Full name of responsible person
Dr Negar Salehi
Position
Oral Medicin Resident
Other areas of specialty/work
Street address
Kerman Dental School, Shafa av.
City
Kerman
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)