Periodontal Microbiota in Systemic Sclerosis

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Periodontal Microbiota in Systemic Sclerosis," is exploring the connection between the bacteria found in the mouth and a rare autoimmune disease called systemic sclerosis (SSc). SSc can cause various symptoms, including inflammation in the gums, which could be influenced by changes in the bacteria in the mouth. The researchers want to better understand how these bacteria differ in patients with SSc compared to individuals without the disease, focusing on the types of bacteria present and their functions.

To participate in this study, you need to be an adult (18 years or older) with a diagnosis of systemic sclerosis made within the last two years. You should have more than 12 teeth for evaluation and be able to give informed consent. The study is looking for participants of all genders, and there are some exclusions, such as pregnancy or active infections. If you join, you can expect to provide information about your oral health and undergo examinations related to the study’s goals. This research aims to shed light on how the bacteria in the mouth could be linked to SSc and may help in understanding this complex disease better.

Gender

ALL

Eligibility criteria

• 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