To determine the effect of adding photodynamic therapy to corticosteroid mouthwash on the
Treatment of ulcerative-erosive oral lichen planus
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 36 patients. Random-Allocation software version 1.0.0 was used for randomization.
Settings and conduct
Patients with ulcerative-erosive lichen planus who are referred to the Oral Diseases Department of Isfahan Dental School during 2025-2026 will be included in the study if they are eligible and will be randomly assigned to intervention and control groups using a randomized block design.
This study will be conducted in a double-blind manner, with patients and those performing patient assessments unaware of the allocation of individuals to groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria;
Patients with ulcerative-erosive oral lichen planus, whose disease was confirmed by histopathological examination.
Exclusion criteria;
Lesions that have evidence of dysplasia in the histopathological view, contact or medicinal lichenoid lesions, patients who have received oral treatment for their lichen planus during the last month, pregnant and lactating patients, people with uncontrolled systemic disease and photosensitive people.
Intervention groups
Intervention groups: mouthwash 0.5mg dexamethasone was used and in photodynamic therapy, the photosensitizer toluene chloride and Lisotronics (semiconductor diode laser - Warsaw Poland) with a wavelength of 635nm for four sessions was used.
Control group: mouthwash 0.5mg of dexamethasone was used and in photodynamic therapy, the photosensitizer toluene chloride and placebo Lisotronics (semiconductor diode laser - Warsaw Poland). This means that because they are wearing protective glasses, they do not notice that the laser is off) for four sessions was used.
Main outcome variables
pain score, lesion size score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150609022628N1
Registration date:2025-07-19, 1404/04/28
Registration timing:registered_while_recruiting
Last update:2025-07-19, 1404/04/28
Update count:0
Registration date
2025-07-19, 1404/04/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5512
Email address
khozeimeh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-13, 1404/02/23
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding photodynamic therapy to corticosteroid mouthwash on the Treatment of ulcerative-erosive oral lichen planus
Public title
The effect of photodynamic therapy on the Treatment of ulcerative-erosive oral lichen planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ulcerative-erosive oral lichen planus, whose disease was confirmed by histopathological examination.
Exclusion criteria:
Lesions that have evidence of dysplasia in the histopathological view
contact or medicinal lichenoid lesions
patients who have received oral treatment for their lichen planus during the last month
pregnant and lactating patients
people with uncontrolled systemic disease
photosensitive people
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted on 36 patients with oral ulcerative-erosive lichen planus. Using the Random-Allocation version 1.0.0 software, patients will be randomly assigned to two groups in a block-wise manner. First, the number of possible formations of blocks of four (including two people from the intervention group and two people from the control group) is determined, and from the six possible formations of these groups, 9 selections are made to ultimately have 9 blocks of four.The sequence of placement of individuals is determined based on these blocks and the names of the two groups are written on 36 cards based on the same random sequence and each is placed in a sealed envelope to ensure allocation concealment. After that, when the eligible individuals start to apply, the envelopes are opened in the order of their application and the group in which the individual is to be placed is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a randomized double blind clinical trial. In this study, both groups of patients receive the main treatment, but in the intervention group, laser is used, while in the control group, we use a sham laser.The people who evaluate the patient are unaware of the assignment of people to groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculties of Dentistry, Health and Modern Medical Technologies, Isfahan University of Medical Scienc
Street address
Hezarjrib Street, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-05-07, 1404/02/17
Ethics committee reference number
IR.MUI.DHMT.REC.1404.028
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
Pain Score
Timepoint
Before starting intervention , one week, two weeks, one month and two months after starting intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Lesion size score
Timepoint
Before starting intervention, one week, two weeks, one month and two months after starting intervention
Method of measurement
Graded abslang
Intervention groups
1
Description
Control Group : The Control group Patients receive mouthwash containing corticosteroid (0.5 mg of dexamethasone in 5 ml of water) as a standard first-line treatment; Then 30 minutes later, 100,000 units of nystatin solution is applied to prevent candidiasis. Treatment with mouthwash is done 4 times a day. In addition, patients are treated with sham photodynamic therapy. To carry out photodynamic therapy, the photosensitizer tolonium chloride is used on the lesion and 0.5 mm around the lesion using a sterile swab; Then, after 15 minutes, the lesion and 0.5 mm around the lesion a re exposed to sham laser (placebo) In a way that the patient is unaware laser unit is off due to wearing protective eyewear. In order to cover the entire parts of the lesion, in larger lesions, irradiation is performed in several points. In this study, lasotronix semiconductor diode laser (Warsaw, Poland) with a wavelength of 635 nm and a series diameter of 8 mm is used, and the duration of radiation at each point is 15 seconds (according to the manufacturer's instructions). According to the protocol presented in Sadaksharam's study, photodynamic therapy treatment is performed in 4 sessions on days 1, 4, 7 and 15. According to Sadaksharam's study, the follow-up sessions in this study are one week, two weeks, one month and two months after the start of intervention.
Category
Treatment - Devices
2
Description
Intervention group: Patients in intervention groups receive mouthwash containing corticosteroid (0.5 mg of dexamethasone in 5 ml of water) as a standard first-line treatment; Then, 30 minutes later, 100,000 units of nystatin solution is applied to prevent candidiasis. Treatment with mouthwash is done 4 times a day. In addition, patients in the intervention group are treated with photodynamic therapy.To carry out photodynamic therapy, the photosensitizer tolonium chloride is used on the lesion and 0.5 mm around the lesion using a sterile swab; Then, after 15 minutes, the lesion and 0.5 mm around the lesion a re exposed to laser radiation. In order to cover the entire parts of the lesion, in larger lesions, irradiation is performed in several points. In this study, lasotronix semiconductor diode laser (Warsaw, Poland) with a wavelength of 635 nm and a series diameter of 8 mm is used, and the duration of radiation at each point is 15 seconds and the radiation power is 400 mW (according to the manufacturer's instructions). Laser radiation is done in contact mode.According to the protocol presented in Sadaksharam's study, photodynamic therapy treatment is performed in 4 sessions on days 1, 4, 7 and 15. According to Sadaksharam's study, the follow-up sessions in this study are one week, two weeks, one month and two months after the start of intervention.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry Of Isfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezar jrib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
khozeimeh@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Asgari Gholamreza
Street address
Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Esfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
khozeimeh@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
khozeimeh@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faezeh Khozeimeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezarjrib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
khozeimeh@dnt.mui.ac.ir
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
Yes - There is 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
All data is potentially shareable after de-identification.
When the data will become available and for how long
Access period starts 2 months after results are published
To whom data/document is available
The data is made available to anyone who needs this information.
Under which criteria data/document could be used
Anyone who needs this data can email the main project manager and, if they agree, the data will be made available to them.
From where data/document is obtainable
Faezeh Khozeimeh- khozeimeh@dnt.mui.ac.ir
What processes are involved for a request to access data/document
After sending an email to the main project manager and reviewing them, they can receive the information they need within a month.