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A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier
Sponsor: Keystone OrthotropiX
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.
Official title: A 6-month Study on the Safety and Tolerability of a Silicone "Orthotropic" Infant Pacifier
Key Details
Gender
All
Age Range
0 Months - 1 Month
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-04-30
Completion Date
2025-06-13
Last Updated
2026-08-28
Healthy Volunteers
Yes
Interventions
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.
Locations (2)
Wellness Dental
Chandler, Arizona, United States
Arizona Facial Plastic Surgery
Phoenix, Arizona, United States