Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy

March 2, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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).

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 A manual search of publications from the unpublished literature was also conducted.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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: papillary gum biopsies
1 or 2 papillary gum biopsies were performed simultaneously, 1 for histological examination and 1 for immunohistochemistry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week after biopsy has been performed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2011

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ODONT_APHP_HMN2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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