Abstract
Objective: The aim of this study was comparative evaluation of effect of Beclomethasone and Adcortyle in Treatment of Oral Lichen Planus
Design: single blind clinical trial
Method: The target population for study was the patient with histologically documented to have oral lichen planus.
Criteria for inclusion: All patients had symptomatic bilateral erosive or ulcerative oral lichen planus with similar intensity.
Criteria for exclusion: Patients that were not cooperative, Use of another topical or systemic corticosteroid during the study
Sample volume: This research was carried out on 19 patients.
Interventions:Adcortyle, Bechlomethasone.
Main outcom: REU, VAS, kaliakatsoau.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101245678N1
Registration date:2011-07-02, 1390/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-02, 1390/04/11
Registrant information
Name
Hamidreza Abdolsamadi
Name of organization / entity
Faculty of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 7115
Email address
abdolsamadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2009-08-16, 1388/05/25
Expected recruitment end date
2010-09-27, 1389/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparative evaluation of effect of Beclomethasone and Adcortyle in treatment of Oral Lichen Planus
Public title
Evaluation of two type corticosteroids in Treatment of Oral Lichen Planus
Purpose
Treatment
Inclusion/Exclusion criteria
Criteria for inclusion: All patients had symptomatic bilateral erosive or ulcerative oral lichen planus with similar intensity, Not used any systemic or topical corticosteroid, Written informed consent was obtained
Criteria for exclusion: Patients that were not cooperative , use of another topical or systemic during the study
Age
From 33 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
19
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
Ethic committi of "Shahid Beheshti dental faculty"
Street address
Student BLV, Evin freeway, Tehran
City
Tehtran
Postal code
19839
Approval date
2009-03-03, 1387/12/13
Ethics committee reference number
277
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
L43
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
Scaling of lesion
Timepoint
3-6-12 weeks
Method of measurement
REU
2
Description
Pain
Timepoint
3-6-12 weeks
Method of measurement
VAS (Visual Analuge Scaling)
3
Description
Raughness
Timepoint
3-6-12 weeks
Method of measurement
VAS
4
Description
Maximum diameter of lesion
Timepoint
3-6-12 weeks
Method of measurement
periodental prob( millimeter)
Secondary outcomes
1
Description
Candidiasis, Mucosal atrophy
Timepoint
3-6-12 weeks
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Adcortyle was used for treatment of control side. This paste is one of the appropriate drug in treatment oral lichen planus, so used to compare with treatment effect of Bechlomethason spray in oral lichen planus lesions . Adcortyle contains triamcinolone 0.01% in a adhesive carrier ( methyl cellulose). Dose of drug was 3 times a day.Patients first dried side of lesion then covered the lesion with paste and eat anything for one hour.
Category
Treatment - Drugs
2
Description
Intervention in this article is treatment of oral lichen planus lesions with nasal spray Bechlomethasone dipropionate. Dose of drug was 50ugr/paff and used 4 times a day( 2 puff in each time) after meals and before sleep. Patient was demonstrated that spray must closed to lesion and sprayed 2 paff.