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

NCT07793058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Feasibility, Safety and Tolerability of Device

Interventions

DEVICE

BREATHE myofunctional pacifier

The BREATHE myofunctional pacifier is a prototype silicone pacifier designed for infant use. This feasibility study evaluates infant use, acceptability, tolerability, and safety of the prototype. Potential effects on palatal morphology and other oral health outcomes will be evaluated in a subsequent clinical trial and are not primary outcomes of the present feasibility study.

Sponsors & Collaborators

  • Keystone OrthotropiX

    lead INDUSTRY

Principal Investigators

  • Nafys Samandari, DDS · Keystone OrthotropiX

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Months
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2025-06-13
Completion
2025-06-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793058 on ClinicalTrials.gov