Feasibility, Safety and Tolerability of DeviceNCT07793058
A 6-month Study on the Feasibility, Safety, and Tolerability of a Silicone Myofunctional Infant Pacifier
A study testing BREATHE myofunctional pacifier in people with Feasibility, Safety and Tolerability of Device, run by Keystone OrthotropiX at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 months to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Feasibility, Safety and Tolerability of Device
- What is being tested?
- BREATHE myofunctional pacifier
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2023to 13 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- premature babies (lower than 35 weeks' gestation)
- low Apgar scores (less than 7)
- cleft issues
- craniofacial syndromes
- neurological diseases
- upper airway anomalies.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wellness Dental
Chandler, Arizona, 85224
Arizona Facial Plastic Surgery
Phoenix, Arizona, 85016
About this study
Official title: A 6-month Study on the Safety and Tolerability of a Silicone "Orthotropic" Infant Pacifier
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.
Read the detailed description
See information elsewhere in this record
- Being tested
- BREATHE myofunctional pacifier
- Keywords
- myofunctional therapy, pacifier, infants, palatal morphology, safety, acceptability, phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BREATHE myofunctional pacifierDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BREATHE myofunctional pacifier | Experimental | All infants will receive the novel BREATHE myofunctional pacifier Receives: Device: BREATHE myofunctional pacifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of device use
Categorical (Yes/No) feasibility is defined as BREATHE myofunctional pacifier use beyond 2 months of age
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Safety of the device use
Study staff will examine the participants for, and caregivers will report any of the following potential adverse outcomes: oral ulceration, gingival trauma, pain, temporomandibular joint symptoms, aspiration or choking incidents, sleep disruption, airway compromise, device breakage, or allergic reactions.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start30 Apr 2023
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Feasibility, Safety and Tolerability of DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keystone OrthotropiX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nafys Samandari, DDS, Principal investigator, Keystone OrthotropiX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793058
- Sponsor's protocol ID
- KeystoneOrthotropiX-Breathe-01
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will consider sharing data on a case-by-case basis with other investigators. Some of the information is proprietary.
Publications
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.
PubMed 32502910Seto 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.
PubMed 11890066Festila 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.
PubMed 26527989Cenzato 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.
PubMed 34677179
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month Study on the Safety and Tolerability of a Silicone "Orthotropic" Infant Pacifier
- ClinicalTrials.gov ID
- NCT07793058
- Acronym / sponsor ID
- KeystoneOrthotropiX-Breathe-01
- Keywords
- myofunctional therapy, pacifier, infants, palatal morphology, safety, acceptability, phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Keystone OrthotropiXIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See information elsewhere in this record
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BREATHE myofunctional pacifier | Experimental | Device: BREATHE myofunctional pacifierAll infants will receive the novel BREATHE myofunctional pacifier |
Who may qualify
- Ages
- 0 months to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- premature babies (lower than 35 weeks' gestation)
- low Apgar scores (less than 7)
- cleft issues
- craniofacial syndromes
- neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BREATHE myofunctional pacifierThe 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. | Device | BREATHE myofunctional pacifier |
Primary outcome
Feasibility of device use
Time frame: 2 months
Categorical (Yes/No) feasibility is defined as BREATHE myofunctional pacifier use beyond 2 months of age
Acceptability of device use
Time frame: 6 months
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.
1 secondary outcome
Safety of the device use
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 32502910Calvo-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.
- Background: PubMed 11890066Seto 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.
- Background: PubMed 26527989Festila 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.
- Background: PubMed 34677179Cenzato 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.
- Individual participant dataSharing planned: Undecided. We will consider sharing data on a case-by-case basis with other investigators. Some of the information is proprietary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nafys Samandari, DDS principal investigator
Keystone OrthotropiX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHE myofunctional pacifier in people with Feasibility, Safety and Tolerability of Device, run by Keystone OrthotropiX at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of device use (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07793058, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.