Scleroderma SystemicScleroBrossNCT04627857
Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
A study testing Manual toothbrush, Manual toothbrush and water flosser (Philips Sonicare AirFloss) and Sonic toothbrush in people with Scleroderma Systemic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma Systemic
- What is being tested?
- Manual toothbrush, Manual toothbrush and water flosser (Philips Sonicare AirFloss) and Sonic toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Scleroderma Systemic
- Being tested
- Manual toothbrush, Manual toothbrush and water flosser (Philips Sonicare AirFloss), Sonic toothbrush, Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual toothbrushDevice
Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles.
Manual toothbrush and water flosser (Philips Sonicare AirFloss)Device
- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water.
Sonic toothbrushDevice
- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth.
Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)Device
- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Manual toothbrush | Active comparator | Not described Receives: Device: Manual toothbrush |
| Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) | Experimental | Not described Receives: Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss) |
| Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) | Experimental | Not described Receives: Device: Sonic toothbrush |
| Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser | Experimental | Not described Receives: Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing of plaque index between baseline, week 2 and week 4
Measured: day 0, week 2 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Jul 2021
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma SystemicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627857
- Sponsor's protocol ID
- 8014
- Acronym
- ScleroBross
- Status last verified
- Aug 2026
- First submitted
- 6 Nov 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04627857
- Acronym / sponsor ID
- ScleroBross / 8014
- Conditions
- Scleroderma Systemic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Manual toothbrush | Active comparator | Device: Manual toothbrush |
| Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) | Experimental | Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss) |
| Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) | Experimental | Device: Sonic toothbrush |
| Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser | Experimental | Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual toothbrushPatients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles. | Device | Arm 1: Manual toothbrush |
| Manual toothbrush and water flosser (Philips Sonicare AirFloss)- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water. | Device | Arm 2: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) |
| Sonic toothbrush- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth. | Device | Arm 3: Manual toothbrush and water flosser (Philips Sonicare AirFloss Ultra) |
| Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water. | Device | Arm 4: Sonic toothbrush (Philips Sonicare ProtectiveClean) and water flosser |
Primary outcome
Changing of plaque index between baseline, week 2 and week 4
Time frame: day 0, week 2 and week 4
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual toothbrush, Manual toothbrush and water flosser (Philips Sonicare AirFloss) and Sonic toothbrush in people with Scleroderma Systemic, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing of plaque index between baseline, week 2 and week 4 (time frame: day 0, week 2 and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.