Periodontal Microbiota in Systemic Sclerosis

NCT06182293 | Recruiting

• 1 other identifier: 9149
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scleroderma Systemic

Outcome Measures

Primary Outcomes (1)

• Alpha diversity of the periodontal microbiota using Chao-1 index

  Baseline

Study Arms (2)

Systemic sclerosis

OTHER

Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota

Controls

OTHER

Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota

Interventions

Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota OTHER

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.

Controls; Systemic sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women over 18 (adults)
• Affiliation to a social health insurance plan
• More than 12 teeth suitable for evaluation
• 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)
• \- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation

You may not qualify if:

• \- Subject under court protection
• Subject under guardianship or curatorship
• Pregnancy or breastfeeding
• Impossibility to provide accurate information (emergency situation, comprehension difficulties…)
• 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
• Progressive cancer or cancer diagnosed within 2 years prior to the study
• Risk of infective endocarditis
• Previous hematopoietic stem cell transplantation
• Another cause of skin sclerosis (radiotherapy of the orofacial area…)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Clinique Dentaire

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Sophie JUNG, MD

CONTACT

03.88.11.69.10; sophie.jung1@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 26, 2023
• Study Start: October 24, 2024
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)