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