Periodontal Microbiota in Systemic Sclerosis (Periomicross)

Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study

Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals with a permissive genetic background. Patients show a wide spectrum of clinical features including periodontitis, which is an inflammatory disease of the tooth-supporting tissues resulting from dysbiosis of the periodontal microbiota guided by inflammophilic bacteria.

The microbiota plays a fundamental role in the induction, training, and function of the host immune system. Numerous studies have highlighted the impact of an altered microbiota, i.e. dysbiosis, on the pathogenesis of immune-mediated diseases. Indeed, commensals are important to maintain immune homeostasis and changes in the microbial composition can be responsible for a loss of tolerance. SSc has been shown to be associated with gut dysbiosis and a depletion of commensals. However, although the oral cavity is one of the two largest microbial habitats, only one study (only focusing on Lactobacillus species) has investigated the oral microbiota in SSc. As periodontal dysbiosis is known to induce low-grade systemic inflammation and represents a risk factor for the development of various autoimmune diseases, the relationship between periodontal microbiota composition and SSc merits further exploration.

The aim of this pilot study is to characterize the taxonomic composition and metabolic pathways of the periodontal microbiota in SSc patients and age and sex-matched controls.

Study Overview

• Status: Recruiting
• Conditions: Scleroderma Systemic
• Intervention / Treatment: Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie JUNG, MD; Phone Number: 03.88.11.69.10; Email: sophie.jung1@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Clinique Dentaire
    • Contact: Sophie JUNG, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Common inclusion criteria

• Men or women over 18 (adults)
• Affiliation to a social health insurance plan
• Subject able to understand the aims and risks of the research and to give signed informed consent form prior to the inclusion in the study
• More than 12 teeth suitable for evaluation

Inclusion criteria for systemic sclerosis patients

• Systemic sclerosis patient with a diagnosis based on the American College of Rheumatology/European League Against Rheumatism criteria (LeRoy et al., 1988 ; van den Hoogen et al., 2013)
• Diagnosis made during the 2 years preceding study inclusion (early form of the disease)

Inclusion criteria for controls

- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation

Exclusion Criteria:

• - Subject under court protection
• Subject under guardianship or curatorship
• Pregnancy or breastfeeding
• Impossibility to provide accurate information (emergency situation, comprehension difficulties…)
• Subject currently involved in another clinical trial or in an exclusion period following participation in another clinical trial
• Smoking (≥ 10 cigarettes per day)
• Other associated systemic auto-immune disease (Sjögren syndrome with positive serum anti-SSA and/or anti-SSB auto-antibodies, systemic lupus erythematosus…)
• Progressive chronic illness other than systemic sclerosis
• Acute infection at inclusion
• Progressive cancer or cancer diagnosed within 2 years prior to the study
• Ongoing antibiotic and/or antifungal treatment or within 3 months prior to inclusion
• Probiotics and/or prebiotics intake within 3 months prior to inclusion
• Oral antiseptics within the week before inclusion (chlorhexidin mouthwashes…)
• Risk of infective endocarditis
• Corticosteroids ≥10 mg/day and/or proton pump inhibitors within 3 months prior to inclusion
• Previous hematopoietic stem cell transplantation
• Another cause of skin sclerosis (radiotherapy of the orofacial area…)
• Periodontal specialized treatments, root and/or periodontal surgical treatment and/or subgingival instrumentation within the year before inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Controls	Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota; Subgingival plaque will be collected at 6 sites using sterile curettes after removal of supragingival biofilm by brushing. After microbial DNA extraction, whole metagenome will be sequenced.
Other: Systemic sclerosis	Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota; Subgingival plaque will be collected at 6 sites using sterile curettes after removal of supragingival biofilm by brushing. After microbial DNA extraction, whole metagenome will be sequenced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Alpha diversity of the periodontal microbiota using Chao-1 index	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): October 24, 2025
• Study Completion (Estimated): October 24, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 9149 (CTEP)

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