Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04503824 |
| Other study ID # |
14422019590827 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2020 |
| Est. completion date |
July 29, 2021 |
Study information
| Verified date |
August 2020 |
| Source |
Cairo University |
| Contact |
engy abdeldayem |
| Phone |
01222376959 |
| Email |
engyabdeldayem[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
