Actively Recruiting
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Led by University Hospital, Strasbourg, France · Updated on 2024-08-19
100
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life. The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.
CONDITIONS
Official Title
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female 18 years or older
- Affiliated with a social welfare system
- Signed an informed consent form
- Have more than 12 natural teeth suitable for evaluation
- Diagnosed with systemic sclerosis with skin involvement based on American College of Rheumatology and LeRoy and Metzger criteria
You will not qualify if you...
- Localized scleroderma or systemic sclerosis without skin involvement ("sine scleroderma")
- Fewer than 12 natural teeth suitable for evaluation or wearing complete dentures
- Other progressive chronic illnesses or autoimmune diseases besides systemic sclerosis (e.g., diabetes)
- Causes of mucocutaneous sclerosis unrelated to systemic sclerosis (e.g., radiotherapy in the orofacial area)
- Current use of sonic toothbrush or dental water flosser
- Severe physical disability preventing holding a large-handled toothbrush
- Use of oral antiseptics like chlorhexidine mouthwashes
- Ongoing medical treatments that significantly affect gum condition (e.g., anti-epileptic drugs)
- Smoking 10 or more cigarettes per day
- Unable to provide accurate information due to emergency or comprehension problems
- Under guardianship, curatorship, or judicial protection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Service de parodontologie
Strasbourg, France
Actively Recruiting
Research Team
S
Sophie JUNG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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