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

NCT07793058 | Completed

• 1 other identifier: KeystoneOrthotropiX-Breathe-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

myofunctional therapy; pacifier; infants; palatal morphology; safety; acceptability; phase 1

Outcome Measures

Primary Outcomes (2)

• Feasibility of device use

  Categorical (Yes/No) feasibility is defined as BREATHE myofunctional pacifier use beyond 2 months of age

  2 months

• Acceptability of device use

  Usage of the pacifier as measured in hours/day. An average use of more than 2.1 hours per day during the first 6 months of life will be considered high acceptability.

  6 months

Secondary Outcomes (1)

• Safety of the device use

  6 months

Study Arms (1)

BREATHE myofunctional pacifier

EXPERIMENTAL

All infants will receive the novel BREATHE myofunctional pacifier

Device: BREATHE myofunctional pacifier

Interventions

BREATHE myofunctional pacifier DEVICE

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.

BREATHE myofunctional pacifier

Eligibility Criteria

• Age: 0 Months - 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• premature babies (lower than 35 weeks' gestation)
• low Apgar scores (less than 7)
• cleft issues
• craniofacial syndromes
• neurological diseases
• upper airway anomalies.

Sponsors & Collaborators

• Keystone OrthotropiX: lead

Study Sites (2)

Wellness Dental

Chandler, Arizona, 85224, United States

Location

Arizona Facial Plastic Surgery

Phoenix, Arizona, 85016, United States

Location

Related Publications (4)

• Calvo-Henriquez C, Capasso R, Chiesa-Estomba C, Liu SY, Martins-Neves S, Castedo E, O'Connor-Reina C, Ruano-Ravina A, Kahn S. The role of pediatric maxillary expansion on nasal breathing. A systematic review and metanalysis. Int J Pediatr Otorhinolaryngol. 2020 Aug;135:110139. doi: 10.1016/j.ijporl.2020.110139. Epub 2020 May 25.

  PMID: 32502910 BACKGROUND

• Seto BH, Gotsopoulos H, Sims MR, Cistulli PA. Maxillary morphology in obstructive sleep apnoea syndrome. Eur J Orthod. 2001 Dec;23(6):703-14. doi: 10.1093/ejo/23.6.703.

  PMID: 11890066 BACKGROUND

• Festila D, Ghergie M, Muntean A, Matiz D, Serb Nescu A. Suckling and non-nutritive sucking habit: what should we know? Clujul Med. 2014;87(1):11-4. doi: 10.15386/cjm.2014.8872.871.df1mg2. Epub 2014 Jan 30.

  PMID: 26527989 BACKGROUND

• Cenzato N, Nobili A, Maspero C. Prevalence of Dental Malocclusions in Different Geographical Areas: Scoping Review. Dent J (Basel). 2021 Oct 11;9(10):117. doi: 10.3390/dj9100117.

  PMID: 34677179 BACKGROUND

Study Officials

• Nafys Samandari, DDS

  Keystone OrthotropiX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The device is a simple silicone myofunctional pacifier. Pacifiers are not regulated by the FDA. For this reason, more than 20 infants were recruited. After this trial, we intend to conduct full clinical trials to study the device's potential health benefits.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 28, 2026
• Study Start: April 30, 2023
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: August 28, 2026

Record last verified: 2026-08

Locations

US (2)