The objective of the present study is to evaluate the therapeutic effect of aloe vera gel and topical steroids (triamcinolone) in topical treatment of oral lichen planus lesions. In this double blind trial, 50 patients, aged 23-70 years referring to Oral Medicine Department of Shiraz Dental School who were diagnosed to have oral lichen planus lesions, were recruited. These patients were randomly assigned into the following groups to receive Aloe vera gel 70% or topical triamcinolone gel 0.1%. The patients were asked to apply 40 grams of drugs topically on oral lesion sites, three times a day for two months. They didn’t use any other drug in this two month period. The patients were visited every other weeks and their treatment response and reduction in pain was evaluated by Thongprasom scale and visual Analogue scale respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904284413N1
Registration date:2011-03-29, 1390/01/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-29, 1390/01/09
Registrant information
Name
Lida Tazesh
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 0458
Email address
tazesh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2010-02-04, 1388/11/15
Expected recruitment end date
2010-07-06, 1389/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between the effect of aloe vera gel and topical corticosteroid in the treatment of oral lesions of lichen planus
Public title
A comparison between the effect of aloe vera gel and topical corticosteroid in the treatment of oral lesions of lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical and histopathological diagnosis of OLP, age at least 18 years
Exclusion criteria: pregnancy, lesions in contact with dental amalgam, the use of drugs possibly causing a lichenoid reaction, any treatment for OLP or immunosuppressive drugs for pre-existing disease within the 4 weeks prior to the study, history of hypersensivity to AV
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Aloe vera gel was prepared by adding sodium meta B sulfite as oxidation inhibitor, sorbitol (sweetener) and sodium methyl carboxycellulose for gelatinization process to aloe vera extract of 70%. Triamcinolone in orabase contained the same ingredients as that of aloe vera with the exception of aloe vera extract which replaced by 70% water to obtain 0.1% triamcinolone. These two drugs were prepared in Laboratory of Shiraz School of Pharmacology.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand St., Shiraz
City
Shiraz
Postal code
Approval date
2010-11-11, 1389/08/20
Ethics committee reference number
CT-89-5305
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Treatment oral lesions of lichen planus
Timepoint
Before treatment, two weeks, four weeks, six weeks, eight weeks after treatment
Method of measurement
Clinical - Symptomatology
Secondary outcomes
empty
Intervention groups
1
Description
Aloe vera, Topical gel %70 ,Three times a day for two mounths
Category
Treatment - Drugs
2
Description
Triamcinolone, Topical gel 0/1%, Three times a day for two mounths
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral Medicine and Diagnosis of Shiraz Dental School
Full name of responsible person
Lida Tazesh, Resident of Oral Medicine
Street address
Oral Medicine and Diagnosis Department, Dental school, Ghasrodasht Street, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Dabbagh Manesh, Associate Professor, Endocrinologist
Street address
Central department of Chancellery for Research, Seventh flat, Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
ردیف بودجه طرح های تحقیقاتی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Shiraz 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
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Lida Tazesh
Position
Dentist, Oral Medicine Resident
Other areas of specialty/work
Street address
Ghasrdasht street
City
Shiraz
Postal code
71956-15878
Phone
+98 71 1628 0458
Fax
+98 71 1628 0458
Email
tazesh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Lida Tazesh
Position
Dentist, Oral medicine resident
Other areas of specialty/work
Street address
Ghasrdasht Street
City
Shiraz
Postal code
71956-15878
Phone
+98 71 1628 0458
Fax
+98 71 1628 0458
Email
tazesh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences & Health Services
Full name of responsible person
Lida Tazesh
Position
Dentist, Oral medicine resident
Other areas of specialty/work
Street address
Ghasrdasht street
City
Shiraz
Postal code
71956-15878
Phone
+98 71 1628 0458
Fax
+98 71 1628 0458
Email
tazesh@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)