An observational study in Oral Lichen Planus and Periodontitis, sponsored by Catholic University of the Sacred Heart. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Catholic University of the Sacred Heart · Observational
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.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
This study's planned enrollment of 176 is above the median of 75 across 38 observational studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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 (GVHD) History of haematopoietic stem cell transplantation () Pregnancy Oncologic patients (including oral cancers) Smokers Diabetes mellitus Obesity Metabolic syndrome therapy Medications causing gingival hyperplasia
Control group only
Immune-mediated inflammatory diseases with oral involvement (e.g. psoriasis, systemic or discoid lupus erythematosus) oral diseases other than OLP
OLP group only
Immunosuppressive therapy for conditions other than OLP Autoimmune oral diseases other than OLP
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Catholic University of the Sacred Heart →