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Dental device study aims to prevent gum woes in kids

NCT ID NCT07410442

Knowledge-focused Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study watches children aged 3 to 9 who need a dental device called a distal shoe after losing a baby tooth early. The goal is to see how often gum problems happen and what makes treatment work best. Researchers hope to create better guidelines for dentists to monitor and manage these issues.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

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.

Who is studied

The study population consists of pediatric patients recruited from the University of Florida College of Dentistry Pediatric Dental Clinic. Participants are children aged 3 to 9 years, classified as ASA I or II, who require distal shoe therapy as part of their standard clinical care following premature loss of a primary second molar. This population represents a clinical sample of children undergoing established space maintenance procedures under general anesthesia due to behavioral or clinical necessity.

Ages

3 to 9 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 * Pediatric participants aged 3 to 9 years * American Society of Anesthesiologists (ASA) Physical Status I or II * Clinical indication for distal shoe therapy as the standard of care * Undergoing distal shoe space maintainer placement * Parent or caregiver able to provide consent and comply with follow-up visits Exclusion Criteria * Presence of systemic medical conditions that may affect bone metabolism or wound healing * Patients unable or unwilling to comply with the planned follow-up schedule (up to 24 months) * Patients with contraindications to distal shoe therapy based on clinical judgment

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As listed by the trial registrant

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

Premature loss of primary molars Soft tissue inflammation Space maintainer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Pediatric Dentistry, Universit of Florida, College of Dentistry

    NOT_YET_RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

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