An observational study in Pemphigoid, Benign Mucous Membrane and Gingivitis Hyperplastic, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Centre Hospitalier Universitaire de Nice · Observational
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.
Cases: 15 adult patients (over 18 years of age) with CP with erosive gingival expression (CP patients).
Control group 1: 15 adult patients (over 18 years of age) without CP, matched to cases on age, gender and periodontal conditions.
Control group 2: 15 adult patients (over 18 years of age) without CP, with healed periodontal conditions, matched to cases on age and gender.
Adults (over 18), non-smokers Arm 1
Arm 3:
Exclusion Criteria:
15 adult patients with MMPg and periodontitis
Other: Plaque sampling and stool collection · Other: periodontal examination
15 adult patients not suffering from MMPg with periodontitis
Other: Plaque sampling and stool collection · Other: periodontal examination
15 adult patients not suffering from MMPg with healthy periodontal conditions
Other: Plaque sampling and stool collection · Other: periodontal examination
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
composition of the periodontal microbiota
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
Time frame: at inclusion
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).
stool sampling at the patient's home after inclusion
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
Plan to share: No
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Centre Hospitalier Universitaire de Nice