Oral lichen planus (OLP) is a chronic mucosal disease. The eatiology of this disease is unknown but immunodeficiency may have a role in the pathogenesis. Up to now use of topical steroid is the most common treatment, but these drugs have some side effects so today use of herbal extract is considered as a treatment with low side effect. In this study we evaluated the Comparative effectiveness of the bioadhesive paste containing licorice %5 and topical corton for the treatment of oral lichen planus. Inclusion criteria: older than 18 years of age. Exclusion criteria: patient with systemic disease; pregnancy; smoking; lesion with displasia; those who received treatment for OLP at least 1 month previous to beginning the study; lesion adjacent to amalgam filling.
Study population: 20 people divided two group A) group with licorice bioadhesive paste %5, B) group b bioadhesive paste with triamcinolone %1 the effect of treatment on pain and clinical symptoms will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110123133N4
Registration date:2012-06-10, 1391/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-10, 1391/03/21
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
2009-03-21, 1388/01/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of bioadhesive paste containing licorice %5 and topical corton for the treatment of oral lichen planus
Public title
treatment Mucosal lesions with licorice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: older than 18 years of age Exclusion criteria: patient with systemic disease; pregnancy; smoking; lesion with displasia; those who received treatment for OLP at least 1 month previous to beginning the study; lesion adjacent to amalgam filling
Age
From 18 years old to 69 years old
Gender
Both
Phase
3
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
Not 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, Persian golf boulevard
City
Zahedan
Postal code
9817699693
Approval date
2010-06-21, 1389/03/31
Ethics committee reference number
90-659
Health conditions studied
1
Description of health condition studied
lichen planus
ICD-10 code
l43
ICD-10 code description
lichen planus
Primary outcomes
1
Description
size of lesion
Timepoint
the first week second week first month third month
Method of measurement
with ruler and calpier
Secondary outcomes
1
Description
level of pain
Timepoint
the first week second week first month third month
Method of measurement
Visual analog scale
Intervention groups
1
Description
control group receive oral past with 0.1 % triamsinolon 4 times a day for 12 weeks
Category
Treatment - Drugs
2
Description
intervention group receive oral past with 5% licorice 4 times a day for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Arbabi-Kalati
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
Fateme Arbabi-Kalati
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
Fateme Arbabi-Kalati
Position
Zahedan University of Medical Sciences
Other areas of specialty/work
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Postal code
9817699693
Phone
+98 54 1241 4001
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sicences
Full name of responsible person
Fateme Arbabi-Kalati
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
9817699693
Phone
+98 54 1241 4001
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
Fateme Arbabi-Kalati
Position
Assistant professor
Other areas of specialty/work
Street address
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Postal code
9817699693
Phone
+98 54 1241 4001
Fax
Email
farbabi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)