In this clinical trial the patients with symptomatic oral lichen planus will be enrolled following signing the informed consent. Basic information and data are: age, gender, location, size, severity of symptoms and the size will be measured with posing a clear paper on lesions & detect the margins then pose it on scaled paper. Severity of symptoms will be assessed with visual analog scale. The patients will be randomly assign two groups, 22 persons with drug A and 22 person with drug B. The medications in this study are prepared with cooperation of pharmacologist & marked with A & B. Drug A consist of mouthwash dexamethasone 0.1% (15cc normal saline plus 5cc amp 8mg/ml2) and the other consist of mouthwash triamcinolon acetonide 0.2%(19cc normal saline plus 1cc amp 40mg/mm2) manufactured by Iran Hormone Co. Patients will wash their mouth 5 minutes, 4 times a day after meals & before sleep for four weeks. At the first, second and fourth week of the study, size of lesions & VAS will be measured and the result will be compared between study groups
General information
Acronym
Efficacy of topical corticosteroid in treatment of oral lichen planus
IRCT registration information
IRCT registration number:IRCT201011275256N1
Registration date:2011-05-30, 1390/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-30, 1390/03/09
Registrant information
Name
Fatemeh Owlia
Name of organization / entity
Yazd shahid sadoughi dentistry faculty
Country
Iran (Islamic Republic of)
Phone
+98 35 1621 2222
Email address
dr.olia@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2010-10-26, 1389/08/04
Expected recruitment end date
2011-06-19, 1390/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two different topical corticosteroids in treatment of symptomatic oral lichen planus.
Public title
Efficacy of topical corticosteroid in treatment of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Oral lichen planus patients confirmed with incisional biopsy; their lesions must be symptomatic; they shouldn’t have any systemic disease; not using drug with the side effect of lichenoid reaction and the lesions should not be near amalgam dental restoration.
Exclusion criteria:
Patient cease their treatment or do not come on affirmed time.
Age
From 19 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor for Research, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Research Department, Building No 2,
City
Yazd,
Postal code
8916978477
Approval date
2010-10-25, 1389/08/03
Ethics committee reference number
17/1/79707پ
Health conditions studied
1
Description of health condition studied
Oral lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
Level of burning sensation
Timepoint
Weekly until 4weeks
Method of measurement
Visual Analog Scale
2
Description
Size of lesions
Timepoint
Weekly until 4weeks
Method of measurement
Scaled paper 1mm2
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: mouthwash dexamethasone 0.1%, patients areasked to wash 5 minutes their mouth 4 times daily after meals & before sleep for 4 weeK.it is prepared from mixing 5cc amp dexamethasone 8mg/2ml with 15 cc normal salin.
Category
Treatment - Drugs
2
Description
Second intervention group: mouthwash triamcinolon acetonide 0.2%, patients are asked to wash 5 minutes their mouth 4 times daily after meals & before sleep for 4 weeks . it is prepared from mixing 1cc amp triamcinolon acetonide 40mg/ml with 19 cc normal salin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
dr Fatemeh Ezoddini
Street address
Research Department, Building No 2,
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr. Fateme Owlia
Position
Assisstant Professor
Other areas of specialty/work
Street address
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd,
Postal code
Phone
+98 35 1621 2222
Fax
Email
dr.olia@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
dr hakimeh ahadian
Position
Assistant professor, Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences Yazd Shahi
Other areas of specialty/work
Street address
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
dr_ahadian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty, Yazd Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
fateme owlia
Position
resident of oral medicine
Other areas of specialty/work
Street address
yazd daha fajr ave
City
yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
dr.olia@sssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)