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Gum disease link in mouth condition under investigation

NCT ID NCT07597616

Knowledge-focused Sponsor: Catholic University of the Sacred Heart Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether people with oral lichen planus (a chronic mouth condition) have more gum disease than those without it. Researchers will compare 88 patients with oral lichen planus to 88 healthy people, all getting standard dental exams. The goal is to understand shared inflammation and improve dental care for these patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study finds a link, it could lead to better dental check-ups and treatment plans for people with oral lichen planus.
What could go wrong
This is an observational study, not a treatment trial. It only looks at a small group of people, so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 176 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lichen planus, oral periodontitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oral lichen planus Periodontitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.