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OpenTrials
Completed

NCT Number: NCT04289233

Molecular & Cellular Characterisation of Oral Lichen Planus

The principal research objective is to provide enhanced understanding of the cellular and molecular events important in the pathogenesis of Oral Lichen Planus to enable improved diagnosis and development of novel treatments for patients.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham Dental Hospital and School of Dentistry

Birmingham, West Midlands, B5 7EG, United Kingdom

About this study

The following questions will also be addressed:

  • Are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles? Quantification of these changes would allow the development of a tool to facilitate the accurate measurement of response to treatment.
  • What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia (the investigators have morphometrical data collected from previous research to allow such comparisons).
  • Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology? This would contribute towards making histopathological diagnosis more quantitative, reproducible and accurate.
  • Is it possible to automate such morphometrical analysis/classification? This would allow large data sets to be screened automatically in a shorter time frame and at lower cost than human based screening.
  • Is it possible to determine differences in genetics and gene expression of keratinocytes involved in Oral Lichen Planus compared to those of 'normal' tissue by using biopsy material and an in vitro model of oral lichen planus?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is 16 years old or over
  • Patient is willing and able to provide valid informed consent
  • Patient is attending the Oral Lichen Planus clinic and will be having a routine clinical biopsy taken

Exclusion criteria

  • Patient under 16 years old
  • Patient is immunocompromised
  • Patients with comorbid disease state e.g. other inflammatory disease

Treatment and study plan

Primary outcomes

  1. Histological architecture

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

    Are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles?

  2. Comparisons with other dysplastic lesions

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

    What is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia

  3. Statistical classifications

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

    Is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology

  4. Automation of morphological features

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

    Is it possible to automate such morphometrical analysis/classification?

  5. Molecular expression of Oral Lichen Planus markers

    Time frame: Through study completion, (maximum 12 months from the defined end of study)

    Is it possible to determine differences in genetics and gene expression of keratinocytes involved in Oral Lichen Planus compared to those of 'normal' tissue by using biopsy material and an in vitro model of oral lichen planus?

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2020
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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