Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT04293718

Collaborator

(none)

100

Enrollment

Actual Duration (Months)

Study Details

Study Description

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 A manual search of publications from the unpublished literature was also conducted.

Condition or Disease	Intervention/Treatment	Phase
Gingival Diseases Gingivitis Autoimmune Diseases Oral Lichen Planus	Other: papillary gum biopsies

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Acquired Chronic Erosive Gingivitis: Clinical Relevance of Papillary Gingival Biopsy. Retrospective Bicentric Study of 148 Samples and Systematic Review of the Literature

Actual Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

contributive capacity diagnostic of the papillary biopsy technique [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.