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Can a pacifier that mimics the breast reshape infant oral health?

NCT ID NCT07793058

Symptom relief Sponsor: Keystone OrthotropiX 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

Researchers are testing a new silicone pacifier called BREATHE in healthy infants from birth to 6 months old. The pacifier is shaped to mimic the maternal nipple, which may help the mouth and nose develop better than standard pacifiers. The study asks whether infants will accept the pacifier and whether it is safe to use. Caregivers will track daily use, and researchers will scan the infants' mouths every three months to monitor palate development.

What this could mean

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

Active substance
A prototype silicone pacifier called BREATHE, designed to mimic the maternal nipple and potentially support healthy mouth and nose structure.
What this could lead to
If infants accept the pacifier and it proves safe, it could point toward a way to reduce dental, ear, and sleep problems linked to standard pacifiers.
What could go wrong
This is a small early feasibility study with only 30 infants, so it may not show clear benefits. The pacifier could also cause irritation, choking, or other safety 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.

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

30 people

The number who actually took part.

Started

Apr 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

0 months to 1 month

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * healthy infants with documented, high Apgar scores (7-10) * ages 0 months or less than 1 month * vaginal or Cesarean section births * breast-fed or bottle-fed Exclusion Criteria: * premature babies (lower than 35 weeks' gestation) * low Apgar scores (less than 7) * cleft issues * craniofacial syndromes * neurological diseases * upper airway anomalies.

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As listed by the trial registrant

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

Feasibility, safety and tolerability of device

Contacts and locations

Locations

  • Arizona Facial Plastic Surgery

    Phoenix, Arizona, 85016, United States

  • Wellness Dental

    Chandler, Arizona, 85224, United States