Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid

NCT ID: NCT06291350

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-11-15

Brief Summary

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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

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Conditions

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Pemphigoid, Benign Mucous Membrane Gingivitis Hyperplastic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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MMPg and periodontitis

15 adult patients with MMPg and periodontitis

Plaque sampling and stool collection

Intervention Type OTHER

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

periodontal examination

Intervention Type OTHER

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

no MMPg and periodontitis

15 adult patients not suffering from MMPg with periodontitis

Plaque sampling and stool collection

Intervention Type OTHER

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

periodontal examination

Intervention Type OTHER

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

no MMPg with healthy periodontal conditions

15 adult patients not suffering from MMPg with healthy periodontal conditions

Plaque sampling and stool collection

Intervention Type OTHER

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

periodontal examination

Intervention Type OTHER

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

Interventions

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Plaque sampling and stool collection

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

Intervention Type OTHER

periodontal examination

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nice University Hospital

Nice, , France

Site Status RECRUITING

Paris hospital Pitié Salpetrière (APHP)

Paris, , France

Site Status RECRUITING

Paris hospital Bretonneau (APHP)

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie DRIDI, PUPH

Role: CONTACT

04 92 03 30 07

rachida YATIMI

Role: CONTACT

04 92 03 30 07

Facility Contacts

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Sophie DRIDI, PUPH

Role: primary

04 92 03 30 07

Rachida Yatimi

Role: backup

04 92 03 30 07

Juliette ROCHEFORT

Role: primary

0142178416

Anne-Laure EJEIL

Role: primary

0153111800

Other Identifiers

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23-AOI-05

Identifier Type: -

Identifier Source: org_study_id

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