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

NCT03871114 | Completed DMC

• 1 other identifier: miR-155 OLP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (2)

• Measurement of salivary levels of miR-155 in OLP before treatment

  assessment of miR-155 in saliva of patients with OLP before treatment

  baseline

• Measurement of salivary levels of IL-10 in OLP before treatment

  assessment of IL-10 in saliva of patients with OLP before treatment

  baseline

Secondary Outcomes (2)

• Measurement of salivary levels of miR-155 in OLP after treatment

  4 weeks

• Measurement of salivary levels of IL-10 in OLP after treatment

  4 weeks

Study Arms (2)

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

Control group

Interventions

Triamcinolone Acetonide in orabase DRUG

treatment of OLP with topical steroid

Also known as: topical corticosteroid

OLP patients

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrophic/erosive oral lichen planus

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11431, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolone Acetonide; Orabase; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 12, 2019
• Study Start: March 10, 2019
• Primary Completion: April 10, 2019
• Study Completion: April 25, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

EG (1)