Oral lichen Planus causes pain and affected the nutrition and quality of life of the patients. Due to the high prevalence of disease , common side effects, and resistance to classic drug treatment , in this research we compared the effect of Infra rad low level laser 810 nm with Triamcinolone acetonide 0/2% mouthwash (classic treatment for OLP).
In this randomized controlled clinical trial study 24 patients were selected based on included and excluded criteria(inclusion:patients with diagnose of OLP,patients agree to this RCT and exclusion criteria :receive any corticosteroids drug in recent two month, being in pregnancy or breast feeding period , patient with systemic disorder , lesion with dysplasia ,drug induced licenoid reaction) , which were divided in two groups of 12 people according to sequentional randomized sampling .before starting this research the indicators such as pain (VAS), score and size of the lesion were recorded. The first group were treated by infra red diode laser twice a week with 0/5-2 J/cm2 power density and 300 mW output power up to 10 sessions. The second group were taken Triamcinolone acetonide 0/2% mouthwash for four times daily with anti fungal drugs for a month
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042027501N1
Registration date:2017-06-01, 1396/03/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Mandana Khatibi
Name of organization / entity
Tehran Azad University faculty of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
m_khatibi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Infra- red low level laser 810 nm with Triamcinolone 0.2 % mouthwash in treatment of Oral Lichen Planus lesions
Public title
Comparison of the effect of Infra- red low level laser 810 nm with Triamcinolone 0.2 % mouthwash in treatment of Oral Lichen Planus lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:patients with diagnose of OLP,patients agree to this RCT
exclusion :receive any corticosteroids drug in recent two month, being in pregnancy or breast feeding period , patient with systemic disorder , lesion with dysplasia ,drug induced licenoid reaction
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Ethics Committee of Tehran Azad University Faculty of Dentistry
Street address
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-04-09, 1395/01/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1395,42
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 and Soreness
Timepoint
Before and after treatment and in follow up
Method of measurement
Asking from patients
2
Description
Size of leision
Timepoint
Before and after treatment
Method of measurement
Oral Probe
Secondary outcomes
empty
Intervention groups
1
Description
12 patients were treated by infra red diode laser twice a week with 0/5-2 J/cm2 power density and 300 mW output power up to 10 sessions.
Category
Treatment - Other
2
Description
12 patients in control group will be treated with Triamcinolone acetonide 0.2% and anti fungal( Nystatin ) Tid for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Azad University Faculty of Dentistry, Oral Medicine Department
Full name of responsible person
Dr Soheila Mohamadian
Street address
Tehran Azad University Faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Dr Soheila Mohamadian
Street address
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
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
Tehran Azad University faculty of Dentistry
Full name of responsible person
Dr Soheila Mohamadian
Position
Resident of Oral Medicine
Other areas of specialty/work
Street address
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
soheila.mohammadiann@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Azad University faculty of Dentistry
Full name of responsible person
Dr Mandana Khatibi
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
soheila.mohammadiann@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Azad University Facualty of Dentistry
Full name of responsible person
Dr Soheila Mohammadian
Position
Resident of Oral Medicine
Other areas of specialty/work
Street address
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2256 4571
Fax
Email
soheila.mohammadiann@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)