Periodontal Status in Patients With Oral Lichen Planus

May 19, 2026 updated by: Carlo Lajolo, Catholic University of the Sacred Heart

Studio Retrospettivo Monocentrico di Una Coorte di Pazienti Affetti da Lichen Planus Orale: Caratteristiche, comorbilità e Fattori di Rischio Per la Trasformazione Maligna

This case-control study will enroll 176 patients age- and sex- matched at the Oral Medicine Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome. There will be two groups: The control group will consist of 88 healthy patients enrolled among those routinely attending the dental outpatient clinic. An additional 88 patients diagnosed with OLP will form the case group. Both groups will undergo standard dental examinations, including periodontal probing. The primary objective is to evaluate whether patients with OLP present a higher prevalence and severity of periodontitis compared to healthy subjects. Secondary objectives include the assessment of gingivitis prevalence and RT1 gingival recessions in OLP patients compared with controls. Periodontal status will be assessed using major clinical indices and classified according to the 2017 AAP/EFP case definition. The study aims to contribute evidence on the shared immune-inflammatory mechanisms underlying both conditions, with potential clinical implications for the integrated periodontal management of OLP patients.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with oral lichen planus (OLP) attending the Oral Medicine Unit at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, and healthy subjects presenting to the same outpatient clinic for routine dental care, without clinical evidence or history of oral mucosal lichen planus. Both groups will be matched 1:1 for age and sex. Patients with major systemic confounders known to affect periodontal status, including diabetes mellitus, obesity, metabolic syndrome, and smoking, will be excluded from both groups to increase internal validity.

Description

Inclusion Criteria:

  • OLP group (case)

Age ≥ 18 years Clinical and histopathological diagnosis of OLP according to WHO criteria (2021)

Control group

Age ≥ 18 years Absence of clinical signs of OLP

Exclusion Criteria:

  • Both groups

Oral lichenoid lesions (OLL): oral lichenoid contact reactions (OLCR), lichenoid drug reactions (LDR), lesions associated with food/substances (e.g. cinnamon) Oral lesions associated with graft-versus-host disease (GVHD) History of haematopoietic stem cell transplantation (HSCT) Pregnancy Oncologic patients (including oral cancers) Smokers Diabetes mellitus Obesity Metabolic syndrome Immunosuppressive therapy Medications causing gingival hyperplasia

Control group only

Immune-mediated inflammatory diseases with oral involvement (e.g. psoriasis, systemic or discoid lupus erythematosus) Autoimmune oral diseases other than OLP

OLP group only

Immunosuppressive therapy for conditions other than OLP Autoimmune oral diseases other than OLP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort of healthy subject
Cohort of subjects diagnosed with Oral Lichen Planus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of periodontitis in OLP patients compared with age- and sex-matched healthy controls, classified according to the 2017 AAP/EFP staging and grading system
Time Frame: From 20 of May to 15 of June
From 20 of May to 15 of June

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2026

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe