- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555681
Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study.
November 16, 2023 updated by: Centre Hospitalier Universitaire de Nice
Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study .
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sophie-Myriam DRIDI, PR
- Phone Number: 00033492034702
- Email: dridi.sm@chu-nice.fr
Study Locations
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-
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Paris, France, 75184
- HEnry Mondor
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Chu de Nice
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Nice, Chu de Nice, France, 06003
- Chu de Nice
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification and quantification of 21 bacteria in subgingival dental plaque
Time Frame: The day of patient inclusion.
|
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.
|
Identification and quantification of candida albicans in subgingival dental plaque
Time Frame: The day of patient inclusion.
|
The day of patient inclusion.
Collection of subgingival dental plaque.
Identification and quantification using q-PCR of Candida albicans.
|
The day of patient inclusion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessement of pain
Time Frame: The day of patient inclusion.
|
Assessment of the intensity of oral pain using an analog visual scale (AVS).
|
The day of patient inclusion.
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Assessment of oral quality
Time Frame: The day of patient inclusion.
|
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.
|
Quantify alveolysis and severity.
Time Frame: The day of patient inclusion.
|
Standard X-ray assessment (panoramic X-ray) to determine whether or not alveolysis is present and quantify its severity.
|
The day of patient inclusion.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sophie Myriem DRIDI, Centre Hospitalier Universitaire de Nice
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
September 14, 2020
First Submitted That Met QC Criteria
September 14, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-PP-01
- 2020-A01670-39 (Registry Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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