Comparative evaluation of low-power laser and co2 laser in treatment of patients with oral lichen planus presenting to the oral Medicine Department at the Dentistry faculty in Tehran University of Medical Sciences in 1388-1389.
The aim of this study is to compare the effects of low-power laser and co2 laser on decreasing sign and symptom of oral lichen-planus lesions. It is an open–labeled, before-after study, treating 60 lesions (30 lesions in low-power laser group and 30 lesions in co2 laser group) with clinical and histopathologic diagnosis of lichen-planus. The participants are recruited among the patients who refer to the Oral Medicine Department at the Dentistry Faculty in Tehran University of Medical Sciences (TUMS). The lesions in low-power laser group receive first, visible red laser light then, infra-red laser light every other day for 5 sessions. The lesions in co2 laser group receive laser light at one session and follow-up sessions are the same as low- power laser group. Before treatment and during these sessions the patients will ne asked for pain and burning sensation. The size of lesions is also assessed with scaled tongue blade. The scores of the lesions are recorded each time, based on thongprasom sigh scoring by the researcher. Pain and burning sensation are measured by using visual analogue scale. The patients are examined at the baseline and 2 and 4 weeks and also 2 and 3 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008161559N4
Registration date:2010-09-12, 1389/06/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-12, 1389/06/21
Registrant information
Name
Farzaneh Aghahoseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6611 2437
Email address
aghahose@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-04-04, 1388/01/15
Expected recruitment end date
2010-10-07, 1389/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of low-power laser and co2 laser in treatment of patients with oral lichen planus presenting to the oral Medicine Department at the Dentistry faculty in Tehran University of Medical Sciences in 1388-1389.
Public title
Comparative evaluation of low-power laser and co2 laser in treatment of oral lichen planus.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical and histopathologic diagnosis of lichen planus with clinical criteria, consisting of the presence of symmetric reticular or papular lesions with or without erosive-atrophic components. Histopathologic features of oral lichen planus are: 1) Areas of hyperparakeratosis or hyperorthokeratosis, often with a thickening of the granular cell layer and a saw-toothed appearance to the retepages. 2) Liquefaction degeneration or necrosis of the basal layer. 3) A dense subepithelial band, shaped by infiltration of lymphocytes T and macrophages. 4) Absence of dysplastic changes.
Exclusion criteria: Using drugs (including for the treatment of lichen planus at the first session) and exposure to amalgam fillings.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Dental Sciences Research center, Tehran University of Medical Sciences
Street address
Dental Sciences Research center, Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2010-05-25, 1389/03/04
Ethics committee reference number
890170-10045
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
size of lesions
Timepoint
2 weekly in the first month and then monthly for 3 months
Method of measurement
size of lesions with scaled tongue blade
2
Description
pain and discomfort in the oral lesions
Timepoint
2 weekly in the first month and then monthly for 3 months
Method of measurement
VAS
3
Description
clinical score
Timepoint
2 weekly in the first month and then monthly for 3 month
Method of measurement
Registration the primary scores of lesions and their changes on the follow up period as described in the material and method
Secondary outcomes
empty
Intervention groups
1
Description
Low power laser including red light (λ=633 nm, light exposure dose=0.3 J/cm2) and infrared light (λ=830 nm, light exposure dose=0.3 J/cm2) every other day for 5 sessions
Category
Treatment - Other
2
Description
Co2 laser (λ=10600 nm, 20 W) at one session.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral medicine department of Tehran University of Medical Siences
Full name of responsible person
Dr. Aghahosseini , Dr. Elham Moslemi
Street address
Oral medicine department, Dentistery faculty, Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of dental Science of Tehran University of medical sciences
Full name of responsible person
Dr. Azam khorshidian
Street address
Dental Sciences Research center, Tehran University of Medical Sciences
City
Tehran
Grant name
در اختیار دانشگاه علوم پزشکی تهران
Grant code / Reference number
Tehran University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of dental Science of 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
Oral Medicine Department, Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Moslemi
Position
Resident of oral medicine
Other areas of specialty/work
Street address
Oral medicine department of Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8838 4235
Fax
Email
dr.emoslemi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oral medicine department of Tehran University of Medical Sciences
Full name of responsible person
Dr Farzaneh Aghahoseini
Position
Professor
Other areas of specialty/work
Street address
Oral medicine department, Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8338 4235
Fax
Email
aghahose@ sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)