Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study.

NCT04555681 | Completed

• 2 other identifiers: 20-PP-012020-A01670-39
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Pemphigoid

Outcome Measures

Primary Outcomes (2)

• Identification and quantification of candida albicans in subgingival dental plaque

  The day of patient inclusion. Collection of subgingival dental plaque. Identification and quantification using q-PCR of Candida albicans.

  The day of patient inclusion.

• Identification and quantification of 21 bacteria in subgingival dental plaque

  Identification and quantification using q-PCR of the 21 bacteria most frequently The day of patient inclusion. Collection of subgingival dental plaque. Identification and quantification using q-PCR of the 21 bacteria most frequently found in the dental plaque (including the periopathogenic bacteria)

  The day of patient inclusion.

Secondary Outcomes (3)

• Assessement of pain

  The day of patient inclusion.

• Assessment of oral quality

  The day of patient inclusion.

• Quantify alveolysis and severity.

  The day of patient inclusion.

Interventions

Collection of subgingival dental plaque DIAGNOSTIC_TEST

Identification and quantification using q-PCR of the 21 bacteria most frequently found in the dental plaque (including the periopathogenic bacteria) and Candida albicans.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, CHU de NICE, 06003, France

Location

HEnry Mondor

Paris, 75184, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Preservation of bacteriological samples

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sophie Myriem DRIDI

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 21, 2020
• Study Start: January 19, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)