Lichen Planus and Mean Platelet Volum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-30

Study Completion Date

2019-03-01

Brief Summary

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70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included. The blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample. A surgical biopsy will be performed for histopathological assessment.

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Detailed Description

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70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included for conventional clinical examination under incandescent projected light. Using biopsy as a gold standard, all patients will be biopsied.

Blood Samples For all participants, the blood samples will be drawn between 08:00 and 09:00 AM, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. The MPV and other hematologic parameters will be measured in a blood sample that will be collected in tubes containing EDTA. Complete blood cell analysis will be performed in hematology laboratory, New Kasr Al-Aini Teaching Hospital, Faculty of Medicine, Cairo University. For reliable MPV measurement, the investigator will standardize the time delay between sampling and analysis to \<2 hours for all patients.

Biopsy preparation A surgical biopsy will be performed for histopathological assessment. All clinically identified lesions underwent biopsies where specimens will be placed in 10% buffered formalin for fixation. Paraffin embedded material will be cut into 4 μm thick sections and will be stained with haematoxylin + eosin then submitted for histopathological evaluation by a senior oral pathologist blinded to the clinical findings.

Statistical analysis

The collected data will be entered through the SPSS version 18.0 software. Sensitivity, Specificity, Positive Predictive Value (PPV), Negative Predictive Value (NPV) and Accuracy were calculated for MPV. The results will be compared with histopathological results using Chi-Square test with p value set as \< 0.05.

Conditions

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Lichen Planus, Oral

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sample

Complete blood count

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Biopsy

Eligibility Criteria

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Exclusion Criteria

* Foreseeable missing opportunity of follow-up examination, Pregnancy, heart-, pulmonary, liver- and kidney disease, chronic pain syndrome nursing, drug addiction, recent operations, and diseases like heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No