Pemphigoid Clinical Trial
Official title:
Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study .
Verified date | November 2023 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice | Nice | Chu de Nice |
France | HEnry Mondor | Paris |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Assessement of pain | Assessment of the intensity of oral pain using an analog visual scale (AVS). | The day of patient inclusion. | |
Secondary | Assessment of oral quality | Assessment of oral quality of life using the OHIP-14 score (Oral Health Impact Profile 2014). Periodontal clinical status : dental formula, assessment of tooth mobility, plaque index, gingival inflammation index, periodontal pocket probing, measurement of recessions, extent of erosive gingivitis. | The day of patient inclusion. | |
Secondary | Quantify alveolysis and severity. | Standard X-ray assessment (panoramic X-ray) to determine whether or not alveolysis is present and quantify its severity. | The day of patient inclusion. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05520086 -
Clinical Trial to Evaluate Safety and Efficacy of Cell Therapy in Patients With Cicatricial Conjuntivitis.
|
Phase 1/Phase 2 | |
Completed |
NCT02823067 -
Pruritus and Pemphigoid in Nursing Home Patients
|
||
Recruiting |
NCT02365675 -
Wound Dressings for Pemphigus and Pemphigoid
|
N/A | |
Completed |
NCT03099538 -
Ixekizumab in the Treatment of Bullous Pemphigoid
|
Phase 2 |