Peridontal and Intestinal Microbiota in Patients with Gingival Scarring Pemphigoid

Recruiting

• Conditions: Gingivitis Hyperplastic; Pemphigoid, Benign Mucous Membrane
• Interventions: Other: Plaque sampling and stool collection; Other: periodontal examination

• Registration Number: NCT06291350
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-03-04
• Study Start: 2024-10-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-06-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MMPg and periodontitis	Plaque sampling and stool collection	15 adult patients with MMPg and periodontitis
no MMPg with healthy periodontal conditions	periodontal examination	15 adult patients not suffering from MMPg with healthy periodontal conditions
no MMPg with healthy periodontal conditions	Plaque sampling and stool collection	15 adult patients not suffering from MMPg with healthy periodontal conditions
no MMPg and periodontitis	periodontal examination	15 adult patients not suffering from MMPg with periodontitis
MMPg and periodontitis	periodontal examination	15 adult patients with MMPg and periodontitis
no MMPg and periodontitis	Plaque sampling and stool collection	15 adult patients not suffering from MMPg with periodontitis

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3).	at inclusion
Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3).	at inclusion	stool sampling at the patient's home after inclusion
Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3)	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)	at inclusion

Trial Locations

Locations (3)

Nice University Hospital; 🇫🇷 Nice, France

Paris hospital Pitié Salpetrière (APHP); 🇫🇷 Paris, France

Paris hospital Bretonneau (APHP); 🇫🇷 Paris, France