Clinical trial NCT04555681: Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study.
Official title: Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pemphigoid
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (over 18 years old) consultant in the odontology department of Saint Roch Hospital in Nice or Henri Mondor in Créteil, with erosive gum expression PCs

Brief summary: In patients with gingival cicatricial pemphigoid (CP), clinical experience has shown that periodontal treatment is beneficial in addition to medical treatment, because the latter does not always allow optimal gingival healing. However in practice, the basic periodontal treatment, combining subgingival scaling and debridement, may be insufficient especially for severe forms of erosive gingivitis. Therefore, a better knowledge of the periopathogenic flora in such patients would facilitate the implementation of a more appropriate and efficient periodontal therapy. In order to meet this objective, we propose a qualitative analysis of the periodontal microbiota in case of gingival CP via a bi-centric observational microbiological pilot study.

Detailed description: In gingival cicatricial pemphigoid (PC) patients, clinical experience has shown that periodontal treatment is beneficial in addition to medical treatment, because the latter does not always allow optimal gingival healing. When the tissue remains erosive despite the systemic treatment, and/or local, anti-inflammatory and/or immunosuppressive, patients frequently report persistent oral discomfort that restricts their diet as well as difficulties in brushing their teeth. Accumulation of dental plaque, organized in bacterial biofilms, therefore becomes inavoidable. However, due to their increasing development, studies have revealed that this dysbiotic periodontal microbiota promotes the growth of virulent, anaerobic, proteolytic bacteria, with high invasive and deleterious properties for periodontal tissues. Furthermore, this process would be amplified in the presence of gingival erosive zones. By eliminating the infectious periodontal gateway, periodontal therapy should allow : i/to restore oral comfort ii/ to prevent any systemic oral infectious complications that may affect the general condition of patients or counteract the effects of drug therapies iii/ to limit the aggravation of concomitant periodontal diseases, and therefore the risk of tooth loss. However in practice, the basic periodontal treatment, combining subgingival scaling and debridement does not systematically meet these objectives. One explanation may be found in the quality of dental bacterial biofilms not yet determined for autoimmune bullous diseases. The main objective of our descriptive observational pilot study, was therefore to study the composition of the periopathogenic flora in patients with gingival CP in order to facilitate the implementation of a more appropriate and efficient periodontal therapy. The secondary objectives were to establish a potential correlation between the composition of this flora and the quality of oral life, the severity of the erosive gingival damage, whether or not to initiate medical treatment, and whether or not there is an underlying periodontitis.

Eligibility criteria: Inclusion Criteria:

* Adult patients (over 18 years old) consultant in the odontology department of Saint Roch Hospital in Nice or Henri Mondor in Créteil, with erosive gum expression PCs, in acute or stabilization phase after the introduction of medical treatment, regardless of their general health conditions but without eye damage and laryngée. The diagnosis of PC must have been certified by a hospital dermatologist
* Patients affiliated with Social Security.
* Informed consent signed.

Exclusion Criteria:

* Antibiotic therapy and antifungal 3 months before the study.
* Mechanical periodontal treatment 3 months before the study.
* Refusal of the patient to participate in the study.
* People under legal protection

Primary outcomes:
measure: Identification and quantification of candida albicans in subgingival dental plaque
timeFrame: The day of patient inclusion.
measure: Identification and quantification of 21 bacteria in subgingival dental plaque
timeFrame: The day of patient inclusion.
Secondary outcomes:
measure: Assessement of pain
timeFrame: The day of patient inclusion.
measure: Assessment of oral quality
timeFrame: The day of patient inclusion.
measure: Quantify alveolysis and severity.
timeFrame: The day of patient inclusion.
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Chu de Nice
city: Paris
country: France
facility: HEnry Mondor
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Sophie Myriem DRIDI
role: PRINCIPAL_INVESTIGATOR
References: