PemphigoidNCT04555681
Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study.
An observational study of Pemphigoid, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigoid
- What is being tested?
- Collection of subgingival dental plaque
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Jan 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pemphigoid
- Being tested
- Collection of subgingival dental plaque
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of subgingival dental plaqueDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: The day of patient inclusion.
Secondary outcomes (3)
Assessement of pain
Assessment of the intensity of oral pain using an analog visual scale (AVS).
Measured: The day of patient inclusion.
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.
Measured: The day of patient inclusion.
Quantify alveolysis and severity.
Standard X-ray assessment (panoramic X-ray) to determine whether or not alveolysis is present and quantify its severity.
Measured: The day of patient inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start19 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Myriem DRIDI, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555681
- Sponsor's protocol ID
- 20-PP-01
- Other IDs
- 2020-A01670-39
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study .
- ClinicalTrials.gov ID
- NCT04555681
- Acronym / sponsor ID
- 20-PP-01
- Conditions
- Pemphigoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of subgingival dental plaqueIdentification and quantification using q-PCR of the 21 bacteria most frequently found in the dental plaque (including the periopathogenic bacteria) and Candida albicans. | Diagnostic test | – |
Primary outcome
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.
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)
3 secondary outcomes
Assessement of pain
Time frame: The day of patient inclusion.
Assessment of oral quality
Time frame: The day of patient inclusion.
Quantify alveolysis and severity.
Time frame: The day of patient inclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Myriem DRIDI principal investigator
Centre Hospitalier Universitaire de Nice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigoid, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and quantification of candida albicans in subgingival dental plaque (time frame: The day of patient inclusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.