Protocol summary

Summary
The objective of this study is to compare the treatment effect of Aloe vera mouth wash and Triamcinolon acetonide 0.1% on the oral Lichen Planus that is done on 40 patients. The following patients will be excluded from the study: Pregnant women, those with any systemic diseases, Lichenoid reaction caused by certain drugs, Lichenoid reaction caused by amalgam filling, those who have any treatment within 4 weeks prior to the study, those who have any dysplasia in histopathological report, those who take agents which potentially induce lichenoid rection. Patient in intervention group and control group will receive aloe vera and triamcinolon acetonid mouth wash respectively, for 6 weeks and will be followed up for 2 months. The primary outcomes are size of lesion and Visual Analogue Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803232031N1
Registration date: 2009-12-09, 1388/09/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2009-12-09, 1388/09/18
Registrant information
Name
Mahsa Esfahani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 1051
Email address
m_esfahani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of the effects of Aloe vera mouth wash and Triamcinolon acetonide 0.1% on the oral lichen planus
Public title
The comparative study of the effects of Aloe vera mouth wash and Triamcinolon acetonide 0.1% on the oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of oral lichen planus (reticular, erosive, bollous), clinically and histopathologically proved. Exclusion criteria: Pregnancy, presence of any systemic disease, Lichenoid reaction caused by certain drugs, Lichenoid reaction caused by amalgam filling, having had any treatment within 4 weeks prior to the study, having had any dysplasia in histopathological report, receiving agents which potentially induce lichenoid rection
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Ethic Committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Ghods Avenue
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
8583

Health conditions studied

1

Description of health condition studied
Oral Lichen Planus
ICD-10 code
L43
ICD-10 code description
Diseases of the skin and subcutaneous tissue, Papulosquamous disorders

Primary outcomes

1

Description
Recovery of oral lichen planus lesions
Timepoint
After 1 week, 2 weeks, 1 month, 2 months
Method of measurement
measuring the lesion with graph paper

Secondary outcomes

1

Description
Pain and burning sensation
Timepoint
Baseline, after 1 week, 1 month, 2 months
Method of measurement
VAS

Intervention groups

1

Description
Aloe vera mouth wash, 6 weeks, 4 times daily, 2 spoon as mouth wash
Category
Treatment - Drugs

2

Description
Triamcinolone acetonide mouth wash, 6 weeks, 4 times daily, 4 cc of diluted solution( 1/ 20)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral Medicine Department, College of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mansourian, Dr. Esfahani
Street address
Oral Medicine Department, College Of Dentistry, Tehran University Of Medical Sciences
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Committee Of Dental College, Tehran University Of Medical Sciences
Full name of responsible person
Dr. Khorshidi
Street address
Research Committee Of Dental College, 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
Research Committee Of Dental College, Tehran 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
College Of Dentistry
Full name of responsible person
Dr. Arash Mansourian
Position
Assistant Professor, Department Of Oral Medicine
Other areas of specialty/work
Street address
Teharn Medical University, College Of Dentistry
City
Tehran
Postal code
Phone
+98 21 6649 1051
Fax
Email
m_esfahani@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Of Medical Sciences, College Of Dentistry, Department Of Oral Medicine
Full name of responsible person
Dr. Arash Maosourian
Position
Assistant Professor Of Oral Medicine
Other areas of specialty/work
Street address
Tehran, Enghelab Street, Ghods avenue
City
Tehran
Postal code
Phone
Fax
Email
m_esfahani@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medivcal Sciences, College Of Dentistry
Full name of responsible person
Dr. Esfahani Mahsa
Position
Resident Of Oral Medicine
Other areas of specialty/work
Street address
Tehran University Of Medical Science, College Of Dentistry, Oral Medicine Department
City
Tehran
Postal code
Phone
Fax
Email
esfahani_ma@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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