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Can High-Tech toothbrushes protect gums in scleroderma?

NCT ID NCT04627857

Symptom relief Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether using a sonic toothbrush and a water flosser improves gum health better than a standard manual toothbrush in people with systemic sclerosis, a rare disease that often affects the mouth. About 20 adults with the condition will be randomly assigned to one of three oral hygiene routines and monitored for changes in plaque over four weeks. The goal is to see if these devices can make daily oral care easier and more effective for patients with limited hand function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral hygiene devices: manual toothbrush, sonic toothbrush, and water flosser (Philips Sonicare AirFloss)
What this could lead to
If effective, these devices could offer a practical way to improve gum health and quality of life for people with systemic sclerosis.
What could go wrong
This is a small, early-stage trial with only 20 participants, so results may not apply broadly. The devices may not significantly outperform manual brushing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scleroderma, systemic

Contacts and locations

Locations

  • Service de parodontologie

    Strasbourg, France

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