Periodontal Status in Patients With Oral Lichen Planus: A Case-Control Study

NCT07597616 | Not Yet Recruiting

• 1 other identifier: 7603
• Study Type: observational
• Target: 176
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oral Lichen Planus; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Prevalence and severity of periodontitis in OLP patients compared with age- and sex-matched healthy controls, classified according to the 2017 AAP/EFP staging and grading system.

  From 20 of May to 15 of June

Study Arms (2)

Cohort of healthy subject

Cohort of subjects diagnosed with Oral Lichen Planus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

MeSH Terms

Conditions

Lichen Planus, Oral; Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share