Comparison of effectiveness of the Bioadhesive paste Containing Licorice 5% with Bioadhesive Paste without drug in the Management of Recurrent Aphthous Stomatitis
The present study was aimed to assess the efficacy of the application of licorice bioadhesive paste 5% to the pain control and reduce the healing time of RAS ulcer. A total of 60of patients With history of recurrent aphthous stomatitis, referred to the School of Dentistry in zahedan, were recruited and assigned into one of the three following groups. The Patients received Diphenhydramine Elixir, Bioadhesive paste without licorice, or paste with licorice, (four times daily for 5 days). Size of ulcer, the necrosis diameter, and pain intensity were measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011273133N2
Registration date:2011-01-31, 1389/11/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Fateme Arbabi Kalati
Name of organization / entity
Dental school of Zahedan
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 1814
Email address
farbabi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2010-06-04, 1389/03/14
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of the Bioadhesive paste Containing Licorice 5% with Bioadhesive Paste without drug in the Management of Recurrent Aphthous Stomatitis
Public title
Comparison of effectiveness of the Bioadhesive paste Containing Licorice 5% with Bioadhesive Paste without drug in the Management of Recurrent Aphthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of recurrent aphthous stomatitis, Current suffering from ulceration in 1 day, signed a well-explained written informed consent form
Exclusion criteria: Pregnancy, lactation (Urine hCG-positive), Ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohn's disease, Behcet's syndrome, serious anemia, treatment with systemic steroid or other immunomodulatory agents within 1 month before the study entry, ulcer in tongue, major RAS, presenting with more 1 aphthous ulcers, after 24 hours' duration of ulcer
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr. Hesabi Square
City
Zahedan
Postal code
892096
Approval date
2010-10-27, 1389/08/05
Ethics committee reference number
892096
Health conditions studied
1
Description of health condition studied
Recurrent aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
recurrent aphthous stomatitis
Primary outcomes
1
Description
diameter of the lesion with erythematois rim
Timepoint
48 hours
Method of measurement
periodental prob
2
Description
diameter of necrotic zone
Timepoint
48 hours
Method of measurement
periodental prob
3
Description
pain level
Timepoint
48 hours
Method of measurement
visual analoge scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bioadhesive paste Containing Licorice 5% 4 times per days 1h before meal and 20 minutes before sleep
Category
Treatment - Drugs
2
Description
Control group: diphen hydramin elixir, 5 cc, 4 times per days 1h before meal and 20 minute before sleep
Category
Treatment - Drugs
3
Description
Control group: Bioadhesive paste without Licorice 5%, 4 times per days 1h before meal and 20 minute before sleep
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences,
Full name of responsible person
Narjes Akbare
Street address
Zahedan University of Medical Sciences
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Siences
Full name of responsible person
Narjes Akbare
Street address
School of Dentistry of 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 Siences
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
Narjes Akbare
Position
Resident Dept of Oral Medicine
Other areas of specialty/work
Street address
School of Dentistry of Zahedan
City
Zahedan
Postal code
00985412431289
Phone
+98 54 1243 1289
Fax
+98 54 1241 4004
Email
narges_akbare4021@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
Fateme Arbabi Kalati
Position
Assistant Professor, Dept of oral medicine
Other areas of specialty/work
Street address
School of Dentistry of Zahedan
City
Zahedan
Postal code
Phone
+98 54 1241 1289
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Narjes Akbare
Position
Resident Dept of oral medicine
Other areas of specialty/work
Street address
School of Dentistry of Zahedan
City
Zahedan
Postal code
Phone
+98 54 1342 1289
Fax
+98 54 1241 4004
Email
narges_akbare4021@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)