NCT03687437

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

September 24, 2018

Last Update Submit

July 22, 2019

Conditions

Keywords

Oral lichen planus, mean platelet volume

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Blood sampleDIAGNOSTIC_TEST

Complete blood count

Also known as: Biopsy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients suspected to have oral lichen planus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oral Medicine and Periodontology Department

Cairo, Egypt

Location

Faculty of Dentistry, Cairo University

Giza, Egypt

Location

Related 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.

    PMID: 28055124BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Blood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCytodiagnosisCytological TechniquesDiagnostic Techniques, Surgical

Study Officials

  • Dalia El Rouby, PH

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 27, 2018

Study Start

June 30, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations