Assessing LncRNA DQ786243 and IL-17 Expression in Oral Lichen Planus: A Case Control Study

August 5, 2020 updated by: Engy Mahmoud Abdel Wahed Abdel dayem, Cairo University
Observational case-control study. The current study aims to assess the salivary expression of lncRNA DQ786243 and IL-17 in OLP, to better understand the pathogenesis of OLP and provide effective targets for OLP therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Oral lichen planus (OLP) is a common chronic inflammatory disease associated with cell-mediated immunological dysfunction. OLP can be seen in different clinical presentations. It can be classified as papular (reticular), atrophic (erythematous) and erosive (ulcerative, bullous).1 Numerous predisposing factors have been blamed for causing OLP, including: stress, diabetes, drugs, dental materials, autoimmune diseases, infectious agents and genetic predisposition. 2 Regarding the pathogenesis of OLP, it is a T-cell mediated inflammatory disease where antigen- specific and non-specific mechanisms are hypothesized to be involved3. Antigen-specific mechanisms include antigen presentation by basal keratinocytes and antigen-specific keratinocyte killing by CD8+ cytotoxic T-cells. Non-specific mechanisms include mast cell degranulation, basement membrane disruption, chemokines and matrix metalloproteinase (MMP) activation in OLP lesions.4 Various treatment regimens have been proposed to improve the management of symptomatic OLP, but a permanent cure is not yet available. Treatment regimens are non-specific and directed at eliminating inflammation and immunosuppression.5 Corticosteroids constitute the main stay agent, other available treatment modalities include immunosuppressants, cyclosporin, tacrolimus, and retinoids.6 Long non-coding RNAs (lncRNAs) have been identified as new regulatory molecules. They modulate protein coding gene at the chromatin remodeling level, or the transcriptional and post- transcriptional control level. They play vital roles in cell differentiation, cell growth and apoptosis. lncRNA DQ786243 is drawing attention in the pathogenesis of a variety of inflammatory immune- mediated diseases such as Crohn's disease and OLP.7, 8 A recent study suggested that lncRNA DQ786243 exert its function through interleukins (ILs) including IL-17. T-helper 17 response and its hallmark IL-17 is gaining more evidence for its role and association with many diseases such as

5 Crohn's disease, ulcerative colitis, systemic lupus erythematosus and OLP. IL-17 has been found to participate in the development of autoimmune disease, inflammatory destruction and tumor microenvironments.9, 10

Research question:

What is the salivary expression of lncRNA DQ786243 and IL-17 in Oral Lichen Planus? Population (P): Oral lichen planus Control (C): Healthy individuals Outcome (O): Salivary expression level of lncRNA DQ786243 and IL-17

Objectives:

The current study aims to assess the salivary expression of lncRNA DQ786243 and IL-17 in OLP, to better understand the pathogenesis of OLP and provide effective targets for OLP therapy.

III. Methods:

7. Study design Observational case-control study. 8. Settings Participants will be recruited from the diagnostic centre and Oral Medicine clinic of the Faculty of Dentistry- Cairo University. The recruitment period is expected to extend from January 2020 to January 2021.

A) Participants 9. Eligibility criteria

Inclusion criteria:

  • Patients diagnosed with OLP.
  • Patient who will agree to participate in the study.
  • Patients who will accept to sign the informed consent.

Exclusion criteria:

  • Patients suffering from any systemic disease.
  • Patients suffering from any local inflammatory disease or infection.
  • Pregnant and lactating women. ▪ Smokers.

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

thestudy composes of two groups: healthy controls and OLP. The expression of the two markers will be compared between the two studied groups. In OLP group, the expression of the two markers will be correlated with pain and clinical assessment scores. In addition, OLP group will be subgrouped based on the clinical form: papular, atrophic, erosive. Data of all participants will be entered on Excel sheet. Each participant will be provided an ID number that will be used for data management and placed as a label for the samples.

Group I: 13 healthy individuals Group IIa: 13 papular OLP Group IIb: 13 atrophic OLP Group IIc: 13 erosive OLP

Description

Inclusion Criteria:

  • Patients diagnosed with OLP.

    • Patient who will agree to participate in the study.
    • Patients who will accept to sign the informed consent.

Exclusion Criteria:

  • Patients suffering from any systemic disease.

    • Patients suffering from any local inflammatory disease or infection.
    • Pregnant and lactating women. ▪ Smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group IIa: 13 papular OLP
Diagnostic test: saliva samples
Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.
Group IIb: 13 atrophic OLP
Diagnostic test: saliva samples
Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.
Group IIc: 13 erosive OLP
Diagnostic test: saliva samples
Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.
Group I: 13 healthy individuals
Diagnostic test: saliva samples
Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. Salivary expression of lncRNA DQ786243. ▪ Salivary expression of IL-17 and Salivary expression of lncRNA DQ786243.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2020

Primary Completion (Anticipated)

June 29, 2021

Study Completion (Anticipated)

July 29, 2021

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14422019590827

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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