The present study aims to investigate the effect on lichen damage CO2 oral laser planus treatment. It is a clinical single blind experiment. Among 183 oral lichen planus patients, 50 patients who did not recover using local corticosteroid were selected and, then, randomly divided to two groups of 25 patients as experiment and control group. The control group continued medication using local corticosteroid (Betamethasone pill .5 as daily mouthwash three times a day) and experiment group makes use of CO2 where first laser determines pain and burning rate using CO2 and VAS (measuring scale ruler), then start treating using laser at its highest power 2 watt and CO2 at the needed defocused distance away 1cm) reflecting on friction. Later hydrocoloride CO2 wash mouth Amen Benzyd laser is prescribed for 5 days. Then each group is checked in 15 days, one, three and six month intervals and VAS damage size is measured by ruler scale and recorded accordingly.
Inclusion criteria: written satisfaction by patients, those who OLP is certified by a pathologist since two years ago and has been treated by local corticosteroid.
Exclusion criteria: patients who were treated using local corticosteroid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110414333N21
Registration date:2014-11-27, 1393/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-27, 1393/09/06
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of use and without use of laser treatment on CO2 oral lichen planus damage
Public title
Effect of laser treatment on CO2 oral lichen planus damage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: written satisfaction by patients, those who OLP is certified by a pathologist since two years ago and has been treated by local corticosteroid.
Exclusion criteria: patients who were treated using local corticosteroid.
Age
From 25 years old to 60 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
420/7/پ/35214
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
Pain rate
Timepoint
One day, one, three and six month after 15 medical intervention
Method of measurement
Based on visual pain scale (VAS)
2
Description
Burning rate
Timepoint
One day, one, three and six month after 15 medical intervention
Method of measurement
Based on visual pain scale (VAS)
3
Description
Size of damage
Timepoint
One day, one, three and six month after 15 medical intervention
Method of measurement
Based on visual pain scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The control group continued medication using local corticosteroid (Betamethasone pill .5 as daily mouthwash three times a day). Then control group is checked in 15 days, one, three and six month intervals and VAS damage size is measured by ruler scale and recorded accordingly.
Category
Treatment - Drugs
2
Description
The experiment group makes use of CO2 where first laser determines pain and burning rate using CO2 and VAS (measuring scale ruler), then start treating using laser at its highest power 2 watt and CO2 at the needed defocused distance away (1cm) reflecting on friction. Later hydrocoloride CO2 wash mouth Amen Benzyd laser is used for 5 days. Experiment group is checked in 15 days, one, three and six month intervals and pain rate and VAS damage size is measured by ruler scale and recorded accordingly.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Dr. Kianoosh Farhadzadeh
Street address
Faculty of Dentistry, Gisha Building,Zare Alley, Shariati streets
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Affairs, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mozafari
Position
PhD in Oral and Maxillofacial
Other areas of specialty/work
Street address
Faculty of Dentistry, Gisha Building,Zare Alley, Shariati streets
City
Kermanshah
Postal code
Phone
00
Fax
Email
Mozaffari@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)