Comparison of the effect of Low Level Laser Therapy (660 nm) and Methylene Blue-mediated Photodynamic Therapy with laser (660 nm) in patient with oral ulcerative and erythematosus Lichenoid Reaction
Comparison of the effect of Low Level Laser Therapy(660 nm) and methylene blue-mediated Photodynamic Therapy with Laser (660 nm) in patient with oral ulcerative and erythematosus Lichenoid Reaction
This study will be conducted with the consent and knowledge of eligible patients in the dental clinic of Esfahan Azad University. This study is single blinded. The examiner of oral lesion will not be aware of which treatment method is applied on each side of the mouth. The characteristics of the lesion (pain, burning sense and size of the lesion) are recorded on both sides of the mouth. on one side، low level laser therapy(660 nm) is used، and on the other side ،methylene blue is first used on lesions ،and then 10 minutes later, low level laser therapy(660 nm) is applied. This process is done twice a week for two weeks and one month follow up. pain, duration of clinical recovery of red or ulcerative areas, duration of pain relief and dimensional changes of lesions will be examined.
Participants/Inclusion and exclusion criteria
Clinical diagnosis and pathology of the disease; absence of dysplastic changes in pathology report , patient consent; erythematous and ulcerative (erosive) types of lesion
Intervention groups
In eligible participants, on one side of oral cavity ، low level laser therapy(660 nm) is used ، and on the other side ،methylene blue is first used on lesions ،and then low level laser therapy(660 nm) is applied.
Main outcome variables
Recovery time(The number of days)
dimensional changes of erythematous and ulcerative lesions(in mm²)
Reducing the burning sense of erythematous and ulcerative lesions (VAS)
duration of pain relief erythematous and ulcerative lesions(The number of days)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230522058261N1
Registration date:2023-12-18, 1402/09/27
Registration timing:prospective
Last update:2023-12-18, 1402/09/27
Update count:0
Registration date
2023-12-18, 1402/09/27
Registrant information
Name
Reyhane Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3633 6580
Email address
rey.rezaei@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-19, 1402/09/28
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Low Level Laser Therapy (660 nm) and Methylene Blue-mediated Photodynamic Therapy with laser (660 nm) in patient with oral ulcerative and erythematosus Lichenoid Reaction
Public title
Comparison of the effect of Low Level Laser Therapy and methylene blue-mediated Photodynamic Therapy with Laser in patient with oral ulcerative and erythematosus lichenoid reaction.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis and pathology of oral Lichen Planus or Lichenoid drug eruption
Erythematous and ulcerative types (erosive)
Patient consent
Exclusion criteria:
Dysplasia changes in pathology report
Lack of patient consent
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
on one side of oral cavity ، low level laser therapy(660 nm) is used ، and on the other side ،methylene blue is first used on lesions ،and then low level laser therapy(660 nm) is applied.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who will apply treatment methods on oral lesion will be different from a person who examine the outcome of treatment methods. The examiner of oral lesion will not be aware of which treatment method is applied on each side of the mouth
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Esfahan Branch (Khorasgan)
Street address
Dentistry Faculty .,Esfahan Azad University., University Street., Arghavanieh Blvd.,
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.090
Health conditions studied
1
Description of health condition studied
Erythematous and ulcerative Oral Lichenoid
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Pain
Timepoint
Twice a week
Method of measurement
VAS
2
Description
duration of pain relief erythematous and ulcerative lesions
Timepoint
Each treatment session and follow-up.
Method of measurement
Based on the number of days
3
Description
dimensional changes of the lesion
Timepoint
Twice a week
Method of measurement
Square millimeters
4
Description
Recovery time
Timepoint
Checking during treatment sessions and follow-up
Method of measurement
Number of days
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will include patients that laser 660 nm will be applied on the left side of their mouth.
Category
Treatment - Other
2
Description
Intervention group: On the right side of the same patients, we will first use methylene blue (MB) with a concentration of 0.05 gr per 100 cc for 10 minutes and then 660 nm laser will be applied.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty
Full name of responsible person
Amir Mansour Shirani
Street address
Dentistry Faculty .,Esfahan Azad University., University St., Arghavanieh Blvd.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 31 3500 2153
Email
info@khuisf.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mansour Shirani
Street address
Dentistry Faculty .,Esfahan Azad University., University St., Arghavanieh Blvd.,
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Fax
+98 31 3535 4060
Email
info@khuisf.ac.ir
Web page address
https://isfahan.iau.ir/dental/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mansour Shirani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty .,Esfahan Azad University., University St., Arghavanieh Blvd.,
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2153
Email
am_shirani@khuisf.ac.ir
Web page address
http://prof.khuisf.ac.ir>shirani
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reyhane Rezaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.186,Shahid Ebrahimi Alley., Salmanzadeh St
City
khoy
Province
West Azarbaijan
Postal code
5818645539
Phone
+98 44 3633 6580
Email
rey.rezaei@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reyhane Rezaei
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty .,Esfahan Azad University., University St., Arghavanieh Blvd.,
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Phone
+98 44 3633 6580
Email
reyhane77rezaei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In cases that can be done legally and ethically.
When the data will become available and for how long
The period of access to this information will start on 03-18-2024.
To whom data/document is available
Authorized persons in the study
Under which criteria data/document could be used
If needed, it will be given to a competent officer.
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document