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Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06291350
Acronym
MICROPC
Enrollment
45
Registered
2024-03-04
Start date
2024-10-24
Completion date
2026-11-15
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigoid, Benign Mucous Membrane, Gingivitis Hyperplastic

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.

Interventions

OTHERPlaque sampling and stool collection

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

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
composition of the periodontal microbiotaat inclusionCompare 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

MeasureTime frameDescription
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 inclusionstool sampling at the patient's home after 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
Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3)at inclusion

Countries

France

Contacts

Primary ContactSophie DRIDI, PUPH
dr.sm.dridi@free.fr04 92 03 30 07
Backup Contactrachida YATIMI
yatimi.r@chu-nice.fr04 92 03 30 07

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026