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Smart toothbrush trial for cleft surgery kids pulled before it started

NCT ID NCT03750708

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if using a connected toothbrush (Ara® KOLIBREE) for one month before alveolar bone graft surgery could improve oral hygiene in children aged 5 to 12 with cleft lip and palate. The trial was withdrawn before enrolling any participants, so no results are available. The idea was that better brushing might reduce post-surgery complications like infections or graft loss.

What this could mean

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

Active substance
Ara® KOLIBREE connected toothbrush

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.

Started

Jan 2019

Finished

Feb 2021

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

4 to 11 years

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: * Children aged 5 to 12 years. * Children benefiting from iliac alveolar bone graft (first side for bilateral clefts) as part of the surgical management of unilateral a bilateral cleft lip and palate. * Children benefiting from a pre-operative orthodontic treatment using Quad Helix type (usual protocol). * Collection of the consent of the persons holding the parental authority and of the child participating in the study. * Affiliation to social security. Exclusion Criteria: * Cognitive impairment preventing the satisfactory education for the use of the connected device. * Chronic disease potentially favouring dental infections (congenital or acquired immunosuppression, congenital enamel disease). * Children undergoing secondary alveolar bone grafts (after an unsatisfactory first alveolar bone graft) or undergoing surgery for the second side in bilateral clefts. * Children participating in another interventional research.

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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip/palate

As listed by the trial registrant

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

Cleft lip and palate

Contacts and locations

Locations

  • Hôpital Necker - Enfants Malades

    Paris, 75015, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.