Comparison of Therapeutic Effect of Mucoadhesive Nano-Triamcinolone Gel and Conventional Triamcinolone Gel on Oral Lichen Planus
Design
40 patients with Erosive OLP were divided into two parallel groups receiving conventional Triamcinolone (CT) and Nano-Triamcinolone (NT)
Settings and conduct
The population of the study was 40 eligible patients with OLP referred to the dental research center and dentistry faculty at Isfahan university of medical sciences to participate and were randomly assigned to two groups of 20 each by random number generator software
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Definite Diagnosis of Lichen Planus via Clinial criteria and Histopathology approvement
Range of 17 to 70 years old
The clinical scores of OLP were evaluated on a Thongprasom scale, which categorizes in to 6 grades of (zero = perfectly healthy, 1 = mild white lines without inflammatory regions, 2 = white lines with atrophic regions smaller than 1 cm2, 3 = white lines with atrophic regions larger than 1 cm2, 4 = white lines accompanied with erosive regions less than 1 cm2, 5 = white lines with erosive areas larger than 1 cm2
Completion of Written Consent
Exclusion Criteria:
Breastfeeding
usage of Drugs that cause Lichenoid Reactions
usage of Immuno supressor Drugs
Sensitivity to Corton
Denture Usage
Intervention groups
The severity of pain was evaluated through visual analogue scale (VAS), the size of lesions was measured with paper lace, and the appearance of lesions was measured by Thongprasom scale
Main outcome variables
NT has a better impact on OLP in comparison with CT, but this difference is not statistically significant.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181226042133N1
Registration date:2019-01-08, 1397/10/18
Registration timing:retrospective
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Rastin Sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 3444
Email address
dr.rastinsadeghian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-10, 1395/07/19
Expected recruitment end date
2017-11-17, 1396/08/26
Actual recruitment start date
2016-10-10, 1395/07/19
Actual recruitment end date
2017-11-17, 1396/08/26
Trial completion date
2017-12-01, 1396/09/10
Scientific title
Comparison of Therapeutic Effect of Mucoadhesive Nano-Triamcinolone Gel and Conventional Triamcinolone Gel on Oral Lichen Planus
Public title
Comparison of Therapeutic Effect of Mucoadhesive Nano-Triamcinolone Gel and Conventional Triamcinolone Gel on Oral Lichen Planus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definite Diagnosis of Lichen Planus via Clinial criteria and Histopathology approvement
Range of 17 to 70 years old
The clinical scores of OLP were evaluated on a Thongprasom scale, which categorizes the phenotype of OPL lesions and includes 6 grades (zero = perfectly healthy, 1 = mild white lines without inflammatory regions, 2 = white lines with atrophic regions smaller than 1 cm2, 3 = white lines with atrophic regions larger than 1 cm2, 4 = white lines accompanied with erosive regions less than 1 cm2, 5 = white lines with erosive areas larger than 1 cm2
Completion of Written Consent
Exclusion criteria:
Breastfeeding
usage of Drugs that cause Lichenoid Reactions
usage of Immuno supressor Drugs
Sensitivity to Corton
Denture Usage
Age
From 17 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
This triple-blind randomized clinical trial study (patient, examining physician, and statistic analyzer)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
West Fatemi St.-Etemadzadeh Alley
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2017-09-11, 1396/06/20
Ethics committee reference number
IR.REC.AJAUMS.1396.66
Health conditions studied
1
Description of health condition studied
Oral Lichen Planus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The severity of pain, the size of lesions , Thongprasom scale
Timepoint
days of 2-4-6-14
Method of measurement
The severity of pain was evaluated through 100 mm visual analogue scale, the size of lesions was measured with paper lace, and the appearance of lesions was examined adopting Thongprasom scale
Control group: Patients Receiving non Nano-Triamcinolone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty of Esfahan University of Medical Sciences
Full name of responsible person
دکتر عباسعلی خادمی
Street address
Hezar jerib St.
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
Admin@dnt.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sajjad Mehri
Street address
West Fatemi St.-Etemadzadeh Alley
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
dr.rastinsadeghian@gmail.com
Grant name
Fifty Million Rial
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Rastin Sadeghian
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no.303-Amin Tower-Nazar Gharbi St.
City
Esfahan
Province
Isfehan
Postal code
8175787688
Phone
+98 31 3625 3444
Email
dr.rastinsadeghian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Rastin Sadeghian
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no.303-Amin Tower-Nazar Gharbi St
City
Esfahan
Province
Isfehan
Postal code
8175787688
Phone
+98 31 3625 3444
Email
dr.rastinsadeghian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Rastin Sadeghian
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no.303-Amin Tower-Nazar Gharbi St
City
Esfahan
Province
Isfehan
Postal code
8175787688
Phone
+98 31 3625 3444
Email
Dr.rastinsadeghian@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
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
information of this research are accessible through forms for each patients and Measured citeria are in different pages without the reveal of patients names
When the data will become available and for how long
availability 2 months after publish of results
To whom data/document is available
Iran's National Elites Foundation-َAja university of medical sciences-Esfahan university of medical sciences-Pharmacology Industry
Under which criteria data/document could be used
Regarding the production of a more potent drug in case of Oral Lichen Planus Treatment
From where data/document is obtainable
Iran's National Elites Foundation
What processes are involved for a request to access data/document
Contacting Iran's National Elites Foundation and Dr Rouhani as the head of dental faculty of Research Centre of Aja university of medical sciences
Comments
This Project is conducted for Iran's National Elites Foundation