Oral lichen planus (OLP) is a chronic mucosal disease with an unknown etiology; however, immunodeficiency might have a role in the pathogenesis. Up to now use of topical steroids has been the most common treatment, but these drugs have some side effects so use of herbal extract is considered as a treatment with less side effects. In this study we will evaluate and compare the effectiveness of the bioadhesive paste containing curcumin and topical corticosteroids for the treatment of oral lichen planus. The inclusion criterion is age over 18. Exclusion criteria consist of patients with systemic diseases, pregnancy, smoking, lesions with dysplasia, patients who received treatment for OLP at least 1 month previous to beginning the study, and lesions adjacent to an amalgam restoration. Study population consisting of 20 people will be divided into two groups: A) group with curcumin bioadhesive paste, B) group with bioadhesive paste containing triamcinolone. The effect of treatment on pain and clinical symptoms will be evaluated at follow-up visits..
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122020377N1
Registration date:2015-01-22, 1393/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-22, 1393/11/02
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
2014-12-16, 1393/09/25
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of the bioadhesive pastes curcumin and topical corticosteroid for the treatment of oral lichen planus
Public title
Comparsion of effectiveness of the bioadhesive pastes curcumin and topical corticosteroid for the treatment of oral lichen planus
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
Oral medicine department, faculty of dentistry, Azadegan street,Zahedan
City
Zahedan
Postal code
9811111111
Approval date
2014-12-15, 1393/09/24
Ethics committee reference number
6947
Health conditions studied
1
Description of health condition studied
Oral 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
Use of Visual Analoge Scale (VAS) from 0- 10, 0: no pain and burning sensation and 10: sever pain and burning sensation
Intervention groups
1
Description
Intervention group: Bioadhesive paste Containing curcumin 4 times per days 1h before meal and 20 minutes before sleep for 12 weeks
Category
Treatment - Drugs
2
Description
control group receive oral past with triamsinolon 4 times per days 1h before meal and 20 minute before sleep 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
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 Nosratzehi
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 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
Phone
+95 433287991
Fax
Email
nosratzehi@zaums.ac..ir
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
Phone
+98 54 3328 7991
Fax
Email
nosratzehi@zaums.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
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)