This study aims to check whether the salivary level of Lactate dehydrogenase (LDH) and C-reactive protein (CRP) changes after systemic treatment (steroid therapy) or not.
Design
Clinical trial without control group, randomized, phase 2, 40 patients
Settings and conduct
The study will take place in the department of oral medicine, school of dentistry, medical university of Isfahan.
As recommended in Burket's oral medicine, the patients will be given a dose of 0.5 to 1 mg per kg prednisolone daily for seven days followed by a reduction of 5 mg each subsequent day.
Just before the beginning of treatment and after 2 and 4 weeks, salivary LDH and CRP will be measured by non-stimulating saliva sampling and at last, the pre, and post-treatment measures will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: suffering from erosive lichenoid reaction; have consent to participate in the study
Exclusion criteria: presence of inflammatory and systemic disease; presence of another oral lesion; had received treatment
Intervention groups
All participants will be gathered in one group. They all go under systemic treatment (steroid therapy) and take saliva tests before and after 2 and 4 weeks from the beginning of treatment.
Main outcome variables
Salivary LDH and CRP measured by non-stimulating saliva sampling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160126026209N2
Registration date:2022-06-12, 1401/03/22
Registration timing:registered_while_recruiting
Last update:2022-06-12, 1401/03/22
Update count:0
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
zahra saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5514
Email address
zahra.saberi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of salivary LDH and CRP in patients with oral erosive lichenoid reaction before and after systemic corticosteroid therapy
Public title
Comparative Evaluation of salivary LDH and CRP in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from oral erosive lichenoid reaction that has been definitely diagnosed by histopathologic diagnosis
The patient has consent to participate in the study
Exclusion criteria:
Presence of systemic and inflammatory disease (e.g. Covid disease, blood system malignancies, etc.) that affects study factors (LDH, CRP)
The patient had been receiving former treatment for the study lesion
Presence of another lesion in the patient's mouth
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
3
Non-stimulating saliva sampling
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-04-07, 1401/01/18
Ethics committee reference number
IR.MUI.MED.REC.1401.006
Health conditions studied
1
Description of health condition studied
Erosive lichen planus
ICD-10 code
L43.8
ICD-10 code description
Other lichen planus
Primary outcomes
1
Description
the measure of salivary lactate dehydrogenase
Timepoint
measurement of lactate dehydrogenase just before the beginning of systemic treatment and 14 and 28 days after beginning the use of systemic corticosteroid
Method of measurement
Non-stimulating saliva sampling
2
Description
the measure of salivary C Reactive Protein
Timepoint
measurement of C Reactive Protein just before the beginning of systemic treatment and 14 and 28 days after beginning the use of systemic corticosteroid
Method of measurement
Non-stimulating saliva sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the patient will be given a dose of 0.5 to 1 mg per kg prednisolone daily for seven days followed by a reduction of 5 mg each subsequent day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental School
Full name of responsible person
Dr.Zahra Saberi
Street address
Oral and Maxillofacial medicine department, School of Dentistry, Isfahan University of Medical Sciences School of Dentistry, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
zahra.saberi@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Vice Chancellor for Research of School of Dentistry, Isfahan Unuversity of Medical Sciences School, St.Hezarjarib, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@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
Zahra Saberi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vice Chancellor for Research of School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5514
Fax
+98 31 3792 5569
Email
zahra.saberi@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Saberi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vice Chancellor for Research of School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5514
Fax
+98 31 3792 5569
Email
zahra.saberi@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Saberi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vice Chancellor for Research of School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5514
Fax
+98 31 3792 5569
Email
zahra.saberi@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
Not specified yet
When the data will become available and for how long
Not specified yet
To whom data/document is available
Not specified yet
Under which criteria data/document could be used
Not specified yet
From where data/document is obtainable
Not specified yet
What processes are involved for a request to access data/document