Periodontal Status in Patients With Oral Lichen Planus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCatholic University of the Sacred Heart
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
OLP group (case)
Disqualifiers
Both groups
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
176 Participants
are grouped into 2 trial groupsGroup A: Cohort of healthy subject
Group B: Cohort of subjects diagnosed with Oral Lichen Planus
Trial outcomes
Primary outcomes
1
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 JuneLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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