The effect of curcumin mediated photodynamic therapy on healing of oral lichen planus
Design
A triple blind randomized controlled clinical trial,split mouth design. 7 patients with bilaterally erosive OLP enrolled and followed
Settings and conduct
This clinical trial will be conducted in 1401 in the Department of Oral and Maxillofacial Diseases of Shiraz Dental Faculty. 7. Patients with bilateral lesions of lichen planus are included in the study.
There are 2 groups of lesions: lesions treated with triamcinolone mouthwash and placebo photodynamic therapy as control lesions, and lesions treated with triamcinolone mouthwash and curcumin-mediated photodynamic therapy. Each patient will receive placebo and photodynamic therapy in three sessions in one week.
Patients are initially evaluated and followed up with follow-up sessions. Since all patients received triamcinolone acetonide for two weeks, the possible difference in results can be attributed to the therapeutic effect of curcumin-mediated photodynamic therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:.
Symptomatic erosive lesions
Exclusion criteria:
Age < 18 years
systemic diseases, lichenoid reactions
Intervention groups
14 sides with oral lichen planus are randomly divided into intervention and control sides by block randomization method. Since we do not intend to exclude any patient from standard OLP treatment, all groups will receive triamcinolone acetonide and nystatin mouthwash for two weeks, and will be tapered according to the standard protocol. Intervention lesions will receive three sessions of photodynamic therapy in one week, and control lesions will receive placebo gel and photodynamic therapy (placebo gel and off light source).
Main outcome variables
Thongprasom index, REU clinical score;
VAS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221016056202N1
Registration date:2022-10-23, 1401/08/01
Registration timing:prospective
Last update:2022-10-23, 1401/08/01
Update count:0
Registration date
2022-10-23, 1401/08/01
Registrant information
Name
hanieh farahmand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 103 5288
Email address
h_farahmand@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effects of curcumin mediated photodynamic therapy and topical corticosteroid in tratment of erosive OLP
Public title
Comparing curcumin mediated photodynamic therapy and topical corticosteroid in tratment of oral OLP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of OLP by 2 oral medicine specialists
Presence of bilateral errosive symptomatic lesions
Patients willing to actively participate in the study
Patients that are capable of performing the exact instructions of the treatment protocol.
Exclusion criteria:
Age < 18 years
Pregnancy or lactation
Uncontrolled systemic diseases (hepatopathies, coagulopathies,auto immune or haematological diseases)
History of allergic reactions to the active ingredient (curcumin) used in the clinical trial
Presence of histological signs of dysplasia in the biopsy specimen
Evidence of lichenoid lesions due to specific causes (dental materials, use of drugs inducing lichenoid reactions such as hypertensive or diabetic medications, etc.)
Smokers or heavy drinkers of alcohol.
Diabetic patients
Patients with photosensivity
Lichenoid reaction
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
14
More than 1 sample in each individual
Number of samples in each individual:
2
7 patient with bilateral symptomatic erosive lesions. a total of 14 lesions, 7 case lesions and 7 control lesions.
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient with bilateral erosive OLP included in the study will be considered as follows: one side of the lesion will be the case and the other side will be the control lesion. . The experimental and control side of each patient is randomly selected using randomized blocks. Each block was considered with 4 allocations, including 2 allocations for the intervention and 2 allocations for the control group. Six possible sequences of treatment allocation are listed in each block, each written on a card. Each time a block was selected and the treatment sequence was recorded until treatment allocation was completed for all 7 participants. Randomization will be done by the methodologist. Allocation concealment will be performed by the principal investigator. A sequence is written on each of the 14 cards and sealed. Pockets are placed in a box. An envelope will be assigned to each participant based on the order of registration.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The main researcher, who is responsible for examining and evaluating the lesions before and after the intervention, is unaware of which of the bilateral lesions of the patients is the case or the control. Another researcher is responsible for conducting the therapeutic intervention. The patients do not know which lesions are in the case or control group. The statistician who performs the data analysis is unaware of the case group and control.As a result, the study will be triple blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Dentistry- Shiraz University of Medical Sciences
Street address
Zand Street, Namazi Square, Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
71956-15878
Approval date
2022-08-31, 1401/06/09
Ethics committee reference number
IR.SUMS.DENTAL.REC.1401.067
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
Timepoint
days 0 and 7 and 14 and 28 and 56
Method of measurement
visual analogue scale
2
Description
size of lesion
Timepoint
days 0 and 7 and 14 and 28 and 56
Method of measurement
Digital caliper
3
Description
Clinical manifestations of inflammation
Timepoint
days 0 and 7 and 14 and 28 and 56
Method of measurement
Thongprasom sign scoring
4
Description
Clinical Efficacy of treatment
Timepoint
days 0 and 7 and 14 and 28 and 56
Method of measurement
REU
Secondary outcomes
1
Description
Allergy to curcumin
Timepoint
days 1 and 3 and 5
Method of measurement
Observe the side effects of increased sensitivity
Intervention groups
1
Description
Intervention group: In each photodynamic therapy session Sinanomin 1%( Topical gel contains %1 curcumin as nanoliposome from Exir Nanosina company will applied for 10 minutes in the side that is randomly selected as the case. After that a light cure device will be applied for irradiation with a blue light emitting wavelength of 470 nm for 5 min.
Category
Treatment - Drugs
2
Description
Control group: The other side of each patient that is considered as the control side with receive a placebo irradiation for 5 minutes with no light.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Hanieh Farahmand
Street address
Shiraz, Qasrdasht St., corner of Mehr St., Shiraz Faculty of Dentistry
City
shiraz
Province
Fars
Postal code
71956-15878
Phone
+98 917 103 5288
Email
h_farahmand@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Zand Street, in front of Palestine Street, Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348_14336
Phone
+98 71 3230 5410
Email
h_farahmand@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Vice President of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hanieh Farahmand
Position
postgraduated student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bagh Hoz Street, 6 Salah Building
City
shiraz
Province
Fars
Postal code
71868-96754
Phone
+98 917 104 5288
Email
h_farahmand@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hanieh Farahmand
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Baghe hoze
City
Shiraz
Province
Fars
Postal code
71868-96754
Phone
+98 917 103 5288
Fax
Email
h_farahmand@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hanieh Farahmand
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Baghe hoze
City
Shiraz
Province
Fars
Postal code
71868-96754
Phone
+98 917 103 5288
Fax
Email
h_farahmand@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have decided to publish the article in domestic or foreign magazines. Complete information will be accessible in this way
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available