Impact of Oral Hygiene Devices on Gum Health in Scleroderma Patients
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
This study is testing whether using a sonic toothbrush and a water flosser can improve gum health for people with scleroderma compared to regular manual brushing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04627857 on ClinicalTrials.gov |
What this trial studies
This study evaluates how specific oral hygiene devices, such as a sonic toothbrush and a water flosser, affect gingival health in patients with systemic sclerosis. It is a randomized single-blind trial comparing these devices to standard manual toothbrushing. The focus is on patients with cutaneous involvement of systemic sclerosis, as they often experience significant oral health issues. The study aims to determine if improved oral hygiene can enhance overall gum health and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with systemic sclerosis that includes cutaneous involvement and have more than 12 natural teeth.
Not a fit: Patients with localized scleroderma or those without cutaneous involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better oral health management strategies for patients with systemic sclerosis, potentially improving their quality of life.
How similar studies have performed: While there is limited research specifically on oral hygiene in systemic sclerosis, similar studies on oral health interventions have shown positive outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Adult male or female ≥ 18 years (18th birthday completed)
* Affiliation to a social welfare system
* Signed informed consent form
* More than 12 natural teeth suitable for evaluation
* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria
Exclusion Criteria:
* Localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form)
* Less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s)
* Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)
* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)
* Current use of sonic toothbrush and/or dental water flosser
* Severe manual handicap preventing the patient from holding a toothbrush with a large handle
* Oral antiseptics (e.g. chlorhexidin mouthwashes)
* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
* Smoking (≥ 10 cigarettes per day)
* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
* Individual under guardianship, curatorship or judicial protection
Where this trial is running
Strasbourg
- Service de parodontologie — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sophie JUNG
- Email: sophie.jung1@chru-strasbourg.fr
- Phone: 00333.88.11.69.56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.