Lichen Planus and Mean Platelet Volum

Lichen Planus, Oral Clinical Trial

Official title:

Diagnostic Accuracy of the Mean Platelet Volume in Oral Lichen Planus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687437
• Other study ID #: Mai Zakaria
• Status: Completed
• Start date: June 30, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria is suspected oral lichen planus, age 18-60

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral

Intervention

Diagnostic Test:
• Blood sample
Complete blood count

Locations

Country	Name	City	State
Egypt	Oral Medicine and Periodontology Department	Cairo
Egypt	Faculty of Dentistry, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Gupta S, Ghosh S, Gupta S. Interventions for the management of oral lichen planus: a review of the conventional and novel therapies. Oral Dis. 2017 Nov;23(8):1029-1042. doi: 10.1111/odi.12634. Epub 2017 Mar 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete blood count	blood sample between 08:00 and 09:00 AM and analysis to <2 hours for all patients	Once at the time of the first visit