Evaluation of Salivary Level of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid

July 24, 2019 updated by: Eman Mohamed Amr, Cairo University

Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid

Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4 weeks of topical steroids use

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt, 11431
        • Faculty of Dentistry

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with atrophic/erosive oral lichen planus

Description

Inclusion Criteria:

  • Patients clinically and histopathologically diagnosed as having atrophic/erosive OLP.
  • Patients free from any other oral lesions
  • cooperative patients who agrees to take the supplied medications.
  • Patients who are systemically healthy

Exclusion Criteria:

  • Patients suffering from any systemic disease.
  • Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
  • Treatment with any oral topical medications for at least four weeks prior to the study.
  • Pregnant and lactating women.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
OLP patients
fifteen patients with atrophic /erosive OLP will receive treatment with topical triamcinolone acetonide in orabase 1mg/g 3 times /day and assessed every week for 4 weeks
Drug: Triamcinolone Acetonide in orabase
treatment of OLP with topical steroid
Other Names:
  • topical corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of salivary levels of miR-155 in OLP before treatment
Time Frame: baseline
assessment of miR-155 in saliva of patients with OLP before treatment
baseline
Measurement of salivary levels of IL-10 in OLP before treatment
Time Frame: baseline
assessment of IL-10 in saliva of patients with OLP before treatment
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of salivary levels of miR-155 in OLP after treatment
Time Frame: 4 weeks
assessment of miR-155 in saliva of patients with OLP after treatment
4 weeks
Measurement of salivary levels of IL-10 in OLP after treatment
Time Frame: 4 weeks
assessment of IL-10 in saliva of patients with OLP after treatment
4 weeks

Collaborators and Investigators

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

Sponsor

Cairo University

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)

March 10, 2019

Primary Completion (Actual)

April 10, 2019

Study Completion (Actual)

April 25, 2019

Study Registration Dates

First Submitted

March 9, 2019

First Submitted That Met QC Criteria

March 9, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • miR-155 OLP

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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