Menu
Recruiting NCT06291350

Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid

— Observational Pemphigoid, Benign Mucous Membrane Gingivitis Hyperplastic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plaque sampling and stool collection, periodontal examination.
Who it may be relevant to
Registry conditions: Pemphigoid, Benign Mucous Membrane, Gingivitis Hyperplastic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Characterization of Peroodontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid: a Matched Controlled Study

Overview

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.

Interventions

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

Primary outcome measures

  • composition of the periodontal microbiota [Time frame: at inclusion]
Secondary outcome measures (4)
  • Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3). [Time frame: at inclusion]
  • Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3). [Time frame: at inclusion]
  • Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe) [Time frame: at inclusion]
  • Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3) [Time frame: at inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

France · 3 centers
  • Nice University Hospital — Nice
  • Paris hospital Pitié Salpetrière (APHP) — Paris
  • Paris hospital Bretonneau (APHP) — Paris

Identifiers

NCT: NCT06291350 · 23-AOI-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗