Evaluation of Oxidative Stress Status of Saliva in Oral Lichen Planus Patients before and after Treatment with Triamcinolone Acetonide (0.2%) Mouthrinse
This tudy is before and after clinical trial with the aim of evaluation of oxidative stress status of saliva in oral lichen planus before and after treatment with triamcinolone acetonide (0.2%) Mouthrinse. lichen planus patients according to modified WHO diagnostic criteria 2003 without any previously treatment enrolled in study. unstimulated salivary samples was collected from 22 patients.All patients were prescribed with suspension of triamcinolone acetonide 0.2%, four times a day, for 5 weeks. Patients were instructed to rinse with 5 ml of mouthrinse for 3 minutes and then to expectorate. All patients were placed on follow-up period during 2, 4 and 5 weeks after starting of the treatment. Saliva collection procedure was repeated at the end of 5-week therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092919133N1
Registration date:2014-12-17, 1393/09/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-17, 1393/09/26
Registrant information
Name
Mahdieh-Sadat Moosavi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4151
Email address
ms-moosavi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Personally
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-04-19, 1390/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Oxidative Stress Status of Saliva in Oral Lichen Planus Patients before and after Treatment with Triamcinolone Acetonide (0.2%) Mouthrinse
Public title
Stress marker in Saliva of Oral Lichen Planus Patients before and after Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusio Criteria: patirnts with lichen planus according to modified WHO diagnostic criteria 2003; Not using systemic or topical therapeutics since last 3 months or 1 month respectively
Exclusion Criteria: patients with systemic disease and systemic drug therapy, any supplementary vitamins in the previous 3 months; history of smoking; Patients with lichenoid lesions associated with drugs or restorations
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
fourth floor, number 23, 16 Azar av., Keshavarz
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
123123
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
oxidative stress status of saliva
Timepoint
before and 5 weeks after intervention
Method of measurement
method based on reaction with thiobarbituric acid (TBA).The results were expressed as μmol/1
Secondary outcomes
1
Description
pain
Timepoint
before and 5 weeks after intervention
Method of measurement
VAS
Intervention groups
1
Description
suspension of triamcinolone acetonide 0.2%,(1ml drug and 19ml saline) four times a day, for 5 weeks. Patients were instructed to rinse with 5 ml of mouthrinse for 3 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Oral Medicine, School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr Mahdieh-Sadat Moosavi
Street address
Amirabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
personally
Full name of responsible person
Mahdieh-Sadat Moosavi
Street address
Dentistry Faculty, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
personally
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
Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Mahdieh-Sadat Moosavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amirabad
City
Tehran
Postal code
Phone
+98 21 4279 4151
Fax
Email
ms-moosavi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Dentistry
Full name of responsible person
Arash Mansourian
Position
Associate Professor
Other areas of specialty/work
Street address
Amirabad
City
Tehran
Postal code
Phone
+98 21 4279 4151
Fax
Email
amansourian@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdieh-Sadat Moosavi
Position
Assistant Professor
Other areas of specialty/work
Street address
Amirabad
City
Tehran
Postal code
Phone
+98 21 4279 4151
Fax
Email
ms-moosavi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)