NCT04627857Terminated
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Reason given: not enough patients
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 6 Nov 2020
- Start date
- 1 Jul 2021
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04627857
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)
- Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)
Other illness
- Other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes)
Other
- 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)
- 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)
- Smoking (≥ 10 cigarettes per day)
- Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)
- Individual under guardianship, curatorship or judicial protection
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de parodontologie | Strasbourg | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.