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Completed Not applicable Interventional Accepts healthy volunteers

A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier

ClinicalTrials.gov ID: NCT07793058

Public ClinicalTrials.gov record NCT07793058. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 6-month Study on the Safety and Tolerability of a Silicone "Orthotropic" Infant Pacifier

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this interventional feasibility study is to learn about the feasibility, acceptability, and safety of a novel myofunctional pacifier in infants from birth to 6 months of age. The pacifier is designed to mimic the maternal nipple, which may improve the structures of the mouth and nose to prevent problems caused by standard pacifiers. Long-term use of standard pacifiers has been associated with abnormal orthodontics, ear infections, and even sleep apnea in young children. The main question the study aims to answer is: Will infants accept the new pacifier, and are there any problems with its use? Participants will be followed for 6 months and have digital scans of their oral cavity every three months to monitor the palate's development.

Study identification

NCT ID
NCT07793058
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Keystone OrthotropiX
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
0 Months to 1 Month
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 29, 2023
Primary completion
Jun 12, 2025
Completion
Jun 12, 2025
Last update posted
Aug 27, 2026

2023 – 2025

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Wellness Dental Chandler Arizona 85224
Arizona Facial Plastic Surgery Phoenix Arizona 85016

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07793058, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07793058 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →