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Recruiting Observational

Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid

NCT06291350 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-10-24
Last updated
2025-03-20

Condition(s) studied

Pemphigoid, Benign Mucous MembraneGingivitis Hyperplastic

Investigational drug(s) / intervention(s)

Plaque sampling and stool collectionperiodontal examination

Plaque sampling and stool collection: Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis

periodontal examination: Characterization of the periodontal and digestive microbiota (metagenomic analysis), assessment of clinical attachment loss and alveolysis

Study summary

Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.

Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.

The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: Adults (over 18), non-smokers Arm 1 * MMPg (initial, persistent despite medical treatment, recurrent), periodontitis Arm 2 * non-MMPg, periodontitis, matched to cases on age, gender and severity of periodontitis Arm 3: \- non-MMPg, healthy periodontal conditions, matched to cases on age and gender Exclusion Criteria: * Antibiotic therapy and mechanical periodontal treatment within 3 months prior to study, other chronic general illness of immune or digestive origin

Primary outcome measure(s)

  • composition of the periodontal microbiota — at inclusion
    Compare the composition (name and number of bacterial colonies) of the periodontal microbiota between patients with MMPg and periodontitis (cases) and control patients (non-MMPg with case-matched periodontitis or non-MMPg with healthy periodontium) Identification and quantification of bacterial populations in the subgingival plaque of cases and controls: global shotgun metagenomic approach, genetic sequencing on a third-generation sequencer

Trial sites (3)

FacilityCityRegionStatus
Nice University Hospital Nice France Recruiting
Paris hospital Pitié Salpetrière (APHP) Paris France Recruiting
Paris hospital Bretonneau (APHP) Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06291350 on ClinicalTrials.gov ↗ ← All trials in France