Periodontal Microbiota in Systemic Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- Subject under court protection

Subject under guardianship or curatorship

Pregnancy or breastfeeding

Impossibility to provide accurate information (emergency situation, comprehension difficulties…)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Systemic sclerosisOther 1 intervention
Group B: ControlsOther 1 intervention

Trial outcomes

Primary outcomes

1

Alpha diversity of the periodontal microbiota using Chao-1 index

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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