This study aim to determine the effect of Curcumin gel compared with triamcinolone ointment in the treatment of oral lichen planus patients referred to Oral and Dental School, Guilan University of Medical Sciences, Rasht, Iran. Fifty patients with oral lichen planus without any systemic disease will be enrolled in this study. Biopsy of all patients Lesions will be performed. Patients will be divided randomly into two intervention and control groups. Intervention group will use curcumin gel and control group will use adcortyl ointment on oral lichen planus lesions three times daily after meals for a month. Pain, burning sensation and size of the patient lesions assess before taking topical drugs, at the end of the second week and at the end of the fourth week after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105012950N2
Registration date:2011-06-17, 1390/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-17, 1390/03/27
Registrant information
Name
Sayed Javad Kia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
djavadkia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chacellorship, Guilan University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2012-04-03, 1391/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Curcumin gel compared with triamcinolone ointment in the treatment of oral lichen planus
Public title
Effect of Curcumin gel compared with triamcinolone ointment in the treatment of oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pateints with oral lichen planus. Exclusion criteria: pateints with gall stones; pregnant women; pateints with oral cancer; the local treatment two weeks before therapy or systemic treatment within 4 weeks ago.
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Research Vice Chacellorship of Guilan University of Medical Sciences
Street address
Siadati Ave, Namjoo Ave
City
Rasht
Postal code
Approval date
2011-01-29, 1389/11/09
Ethics committee reference number
12414
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
Burning sensation
Timepoint
Befor appliction of gel and ointment, 2 weeks and 4 weeks after application of gel and ointment
Method of measurement
Visual Analoge Scale
2
Description
Pain and burning sensation
Timepoint
Before application of gel and ointment, 2 weeks and 4 weeks after application of gel and ointment
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
Secondary outcomes
1
Description
Treatment of oral lichen planus lesions (reduce size of lesion)
Timepoint
Before treatment, 2 and 4 weeks after treatment
Method of measurement
Tongprasom scale(0-5)
Intervention groups
1
Description
Intervention: Curcumin Gel-topical use in oral mucosa, 3 time/day, after meal for 1 month
Category
Treatment - Drugs
2
Description
Control: Triamcinolone in oral base Ointment (Adcortyl), topical use in oral mucosa, 3 time/day, after meal, for 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school, Guilan University Of Medical Sciences
Full name of responsible person
Dr. Sayed Javad Kia
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellorship of Guilan University Of Medical Sciences
Full name of responsible person
Dr. Abdolrasool Sobhani
Street address
Shahid Siyadati Ave, Namjoo Ave, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellorship of Guilan 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
Dental School of Guilan University
Full name of responsible person
Dr. Sayed Javad Kia
Position
Assistant Professoer
Other areas of specialty/work
Street address
Pardis, Emam Ave
City
Rasht
Postal code
Phone
00989121888965 - 00981313237877
Fax
Email
Djavadkia@yahoo.com - Djavadkia@Gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School Of Guilan University
Full name of responsible person
Dr. Sayed Javad Kia
Position
Assistant Professor
Other areas of specialty/work
Street address
Pardis, Emam st.
City
Rasht
Postal code
Phone
00981313237877- 00989121888965
Fax
Email
djavadkia@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School Of Guilan University
Full name of responsible person
Dr Sayed Javad Kia
Position
Assistant Professor
Other areas of specialty/work
Street address
City
Rasht
Postal code
Phone
+98 13 1323 7877
Fax
Email
djavadkia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)