Gingival DiseasesNCT04293718
Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy
An observational study of Gingival Diseases and Gingivitis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Chronic erosive gingivitis is a syndrome (CEGS) that combines severe gingival inflammation and gingival erosion. The term "desquamative gingivitis" is often used in the literature to define chronic erosive gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Diseases, Gingivitis, Autoimmune Diseases
- What is being tested?
- papillary gum biopsies
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jul 2019
- 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: Over the study period we were able to study 101 files, but the investigator's final sample of patients included 100 adults. In first-line, 2 papillary gum biopsies were performed simultaneously for 48 of them (48%), 1 for histological examination and 1 for immunohistochemistry. For 47 other patients (47%) only 1 biopsy was performed for histological examination and for the remaining 5 patients (5%) only 1 biopsy for immunofluorescence (DIF).
Who may be able to join
- Patients referred on an outpatient basis by the physician or the dental surgeon, suffering from an acute erosive gingivitis, regardless of age and general health.
Who cannot join
- Patients referred on an outpatient basis by the physician or the dental surgeon, with a histological examination and immunofluorescence (DIF) already done previously, and patient under corticosteroid therapy which is skewing the immunofluorescence (DIF) data.
About this study
Official title: Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy. Retrospective Bicentric Study of 148 Samples and Systematic Review of the Literature
Chronic erosive gingivitis is a syndrome (CEGS) that combines severe gingival inflammation and gingival erosion. The term "desquamative gingivitis" is often used in the literature to define chronic erosive gingivitis. However, this definition is inappropriate because the pathophysiological process at the origin of this gingival disease does not induce a desquamation but rather a loss of gingival substance, namely erosion, concerned wholly or in part of the gingival epithelium. In most clinical situations, chronic erosive gingivitis is an oral manifestation of a general disease with immune dysfunction. The most frequently described diseases are gingival lichen and autoimmune bullous diseases (AIBD). In 2018, as part of a monocentric study, we were the first to detail an original papillary gingival biopsy protocol, non-iatrogenic, perfectly suited to the anatomopathological examinations necessary for the diagnosis of AIBD gingival expression. The CEGS early detection by odontologists avoid delayed diagnosis and allows patients to be referred to the closest AIBD reference center.
Hypothesis/Objective A bicentric study was conducted, to evaluate the clinical relevance of this protocol, including the differential diagnosis of the CEGS. Research was supplemented by carrying out a systematic review of the literature to compare the contributive capacity diagnostic of the papillary biopsy technique with other gingival sample methods (attached gingival tissue, mucosa).
Read more
Method A retrospective bicentric observational study was conducted from October 2011 to July 2019, in two departments of oral medicine of two public hospitals in Paris (University Hospital - Bretonneau in Paris and Henri Mondor in Créteil; France). These two departments are specialized in the diagnosis and management of oral pathology; that of the Henri Mondor hospital is an AIBD reference center.
The literature review was developed in accordance with PRISMA recommendations. It was conducted on Pubmed - MEDLINE and Cochrane Oral Health Group and included all existing publications from 1935 until August 2019. A manual search of publications from the unpublished literature was also conducted.
- Conditions
- Gingival Diseases, Gingivitis, Autoimmune Diseases, Oral Lichen Planus
- Being tested
- papillary gum biopsies
- Keywords
- Erosive gingivitis, Biopsy, Desquamative gingivitis, Gingival disease, Oral lichen planus, Mucous membrane pemphigoid benign, Pemphigus vulgaris
- Medical subject headings
- Gingival Diseases, Gingivitis, Autoimmune Diseases, Lichen Planus, Oral, Pemphigoid, Benign Mucous Membrane, Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
papillary gum biopsiesOther
1 or 2 papillary gum biopsies were performed simultaneously, 1 for histological examination and 1 for immunohistochemistry
| Study group | Role | What they receive |
|---|---|---|
| Acute erosive gingivitis | Patients presenting acute erosive gingivitis, isolated or predominant compared to other oral lesions, which required at least one papillary gingival biopsy for diagnostic purposes. Patients were included in the study regardless of age and general health. Receives: Other: papillary gum biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
contributive capacity diagnostic of the papillary biopsy technique
Diagnosis of certainty of diseases, whose clinical features are the CEGS, have been made by comparing clinical data with histological criteria commonly accepted by the international community
One week after the biopsy has been performed, we can establish the:
- number of contributive results of first-line biopsies performed for conventional histological analysis showing the:
- presence or absence of the epithelium,
- presence or absence of the intra-epithelial or the subepithelial cleavage,
- characteristic of the inflammatory infiltrate, especially the presence and the number of lymphocytes.
- number of contributive results of biopsies performed for direct immunofluorescence showing:
- immune deposits or not, in a linear staining pattern at the chorio-epithelial junction.
- immune deposits or not, in an intercellular staining pattern in the epidermis.
Measured: One week after biopsy has been performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study startOct 2011
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293718
- Sponsor's protocol ID
- ODONT_APHP_HMN2019
- Status last verified
- Jan 2020
- First submitted
- 20 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Position paper: oral features of mucocutaneous disorders. J Periodontol. 2003 Oct;74(10):1545-56. doi: 10.1902/jop.2003.74.10.1545.
PubMed 14653403Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial Pathology. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Sep;122(3):332-54. doi: 10.1016/j.oooo.2016.05.004. Epub 2016 Jul 9.
PubMed 27401683Dridi SM, Bellakhdar F, Ortonne N, Bayet K, Ingen-Housz-Oro S, Gaultier F. [Autoimmune bullous diseases with gingival expression: A proposed non-iatrogenic gingival biopsy technique]. Ann Dermatol Venereol. 2018 Oct;145(10):572-577. doi: 10.1016/j.annder.2018.06.005. Epub 2018 Aug 22. French.
PubMed 30143321Lo Russo L, Fedele S, Guiglia R, Ciavarella D, Lo Muzio L, Gallo P, Di Liberto C, Campisi G. Diagnostic pathways and clinical significance of desquamative gingivitis. J Periodontol. 2008 Jan;79(1):4-24. doi: 10.1902/jop.2008.070231.
PubMed 18166088Rinaggio J, Crossland DM, Zeid MY. A determination of the range of oral conditions submitted for microscopic and direct immunofluorescence analysis. J Periodontol. 2007 Oct;78(10):1904-10. doi: 10.1902/jop.2007.070095.
PubMed 18062112van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.
PubMed 12969224Gaultier F, Ejeil AL, Jungo S, Ingen-Housz-Oro S, de Clatigny FLP, Bruno G, Pirnay P, Bellakhdar F, Dridi SM. Clinical relevance of interdental papilla biopsy in chronic erosive gingivitis (desquamative gingivitis): retrospective bicentric study of 148 specimens. BMC Oral Health. 2021 Sep 17;21(1):452. doi: 10.1186/s12903-021-01820-9.
PubMed 34535102
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy. Retrospective Bicentric Study of 148 Samples and Systematic Review of the Literature
- ClinicalTrials.gov ID
- NCT04293718
- Acronym / sponsor ID
- ODONT_APHP_HMN2019
- Conditions
- Gingival Diseases, Gingivitis, Autoimmune Diseases, Oral Lichen Planus
- Keywords
- Erosive gingivitis, Biopsy, Desquamative gingivitis, Gingival disease, Oral lichen planus, Mucous membrane pemphigoid benign, Pemphigus vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 3 Mar 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.
Chronic erosive gingivitis is a syndrome (CEGS) that combines severe gingival inflammation and gingival erosion. The term "desquamative gingivitis" is often used in the literature to define chronic erosive gingivitis. However, this definition is inappropriate because the pathophysiological process at the origin of this gingival disease does not induce a desquamation but rather a loss of gingival substance, namely erosion, concerned wholly or in part of the gingival epithelium. In most clinical situations, chronic erosive gingivitis is an oral manifestation of a general disease with immune dysfunction. The most frequently described diseases are gingival lichen and autoimmune bullous diseases (AIBD). In 2018, as part of a monocentric study, we were the first to detail an original papillary gingival biopsy protocol, non-iatrogenic, perfectly suited to the anatomopathological examinations necessary for the diagnosis of AIBD gingival expression. The CEGS early detection by odontologists avoid delayed diagnosis and allows patients to be referred to the closest AIBD reference center.
Hypothesis/Objective A bicentric study was conducted, to evaluate the clinical relevance of this protocol, including the differential diagnosis of the CEGS. Research was supplemented by carrying out a systematic review of the literature to compare the contributive capacity diagnostic of the papillary biopsy technique with other gingival sample methods (attached gingival tissue, mucosa).
Method A retrospective bicentric observational study was conducted from October 2011 to July 2019, in two departments of oral medicine of two public hospitals in Paris (University Hospital - Bretonneau in Paris and Henri Mondor in Créteil; France). These two departments are specialized in the diagnosis and management of oral pathology; that of the Henri Mondor hospital is an AIBD reference center.
The literature review was developed in accordance with PRISMA recommendations. It was conducted on Pubmed - MEDLINE and Cochrane Oral Health Group and included all existing publications from 1935 until August 2019. A manual search of publications from the unpublished literature was also conducted.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute erosive gingivitis | – | Other: papillary gum biopsiesPatients presenting acute erosive gingivitis, isolated or predominant compared to other oral lesions, which required at least one papillary gingival biopsy for diagnostic purposes. Patients were included in the study regardless of age and general health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Over the study period we were able to study 101 files, but the investigator's final sample of patients included 100 adults. In first-line, 2 papillary gum biopsies were performed simultaneously for 48 of them (48%), 1 for histological examination and 1 for immunohistochemistry. For 47 other patients (47%) only 1 biopsy was performed for histological examination and for the remaining 5 patients (5%) only 1 biopsy for immunofluorescence (DIF).
Key inclusion criteria (1 listed)
- Patients referred on an outpatient basis by the physician or the dental surgeon, suffering from an acute erosive gingivitis, regardless of age and general health.
Key exclusion criteria (1 listed)
- Patients referred on an outpatient basis by the physician or the dental surgeon, with a histological examination and immunofluorescence (DIF) already done previously, and patient under corticosteroid therapy which is skewing the immunofluorescence (DIF) data.
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 |
|---|---|---|
| papillary gum biopsies1 or 2 papillary gum biopsies were performed simultaneously, 1 for histological examination and 1 for immunohistochemistry | Other | Acute erosive gingivitis |
Primary outcome
contributive capacity diagnostic of the papillary biopsy technique
Time frame: One week after biopsy has been performed
Diagnosis of certainty of diseases, whose clinical features are the CEGS, have been made by comparing clinical data with histological criteria commonly accepted by the international community One week after the biopsy has been performed, we can establish the: * number of contributive results of first-line biopsies performed for conventional histological analysis showing the: * presence or absence of the epithelium, * presence or absence of the intra-epithelial or the subepithelial cleavage, * characteristic of the inflammatory infiltrate, especially the presence and the number of lymphocytes. * number of contributive results of biopsies performed for direct immunofluorescence showing: * immune deposits or not, in a linear staining pattern at the chorio-epithelial junction. * immune deposits or not, in an intercellular staining pattern in the epidermis.
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 3 Mar 2020.
- Background: PubMed 14653403Position paper: oral features of mucocutaneous disorders. J Periodontol. 2003 Oct;74(10):1545-56. doi: 10.1902/jop.2003.74.10.1545.
- Background: PubMed 27401683Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial Pathology. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Sep;122(3):332-54. doi: 10.1016/j.oooo.2016.05.004. Epub 2016 Jul 9.
- Background: PubMed 30143321Dridi SM, Bellakhdar F, Ortonne N, Bayet K, Ingen-Housz-Oro S, Gaultier F. [Autoimmune bullous diseases with gingival expression: A proposed non-iatrogenic gingival biopsy technique]. Ann Dermatol Venereol. 2018 Oct;145(10):572-577. doi: 10.1016/j.annder.2018.06.005. Epub 2018 Aug 22. French.
- Background: PubMed 18166088Lo Russo L, Fedele S, Guiglia R, Ciavarella D, Lo Muzio L, Gallo P, Di Liberto C, Campisi G. Diagnostic pathways and clinical significance of desquamative gingivitis. J Periodontol. 2008 Jan;79(1):4-24. doi: 10.1902/jop.2008.070231.
- Background: PubMed 18062112Rinaggio J, Crossland DM, Zeid MY. A determination of the range of oral conditions submitted for microscopic and direct immunofluorescence analysis. J Periodontol. 2007 Oct;78(10):1904-10. doi: 10.1902/jop.2007.070095.
- Background: PubMed 12969224van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.
- Derived from this study: PubMed 34535102Gaultier F, Ejeil AL, Jungo S, Ingen-Housz-Oro S, de Clatigny FLP, Bruno G, Pirnay P, Bellakhdar F, Dridi SM. Clinical relevance of interdental papilla biopsy in chronic erosive gingivitis (desquamative gingivitis): retrospective bicentric study of 148 specimens. BMC Oral Health. 2021 Sep 17;21(1):452. doi: 10.1186/s12903-021-01820-9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Diseases and Gingivitis, run by Assistance Publique - Hôpitaux de Paris.
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 1 inclusion and 1 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
contributive capacity diagnostic of the papillary biopsy technique (time frame: One week after biopsy has been performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293718, which also lists 7 linked publications.
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 3 Mar 2020.