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Completed NCT07793058

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

Conditions: Feasibility, Safety and Tolerability of Device

Sex: All
Ages: 0 Months – 1 Month
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Keystone OrthotropiX

Location: Wellness Dental Chandler Arizona

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07793058). StuddyBuddy aggregates publicly available trial information.