NCT07738185 The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes
| NCT ID | NCT07738185 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Isaac Elijah |
| Condition | Ankyloglossia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-01-27 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This purpose of this study is to investigate whether performing sublingual massages after frenotomy reduces the recurrence of ankyloglossia (e.g., "tongue-tie". After consent from the parents or guardians, infants who received underwent frenotomy will be randomized to either complete sublingual massages according to a specified description and schedule, or they will be randomized to the control group where they will be instructed to perform no massages. The main question to answer is do these massages reduce the likelihood of tongue-tie recurrence or not. Secondary question is will there be any significant difference on feeding practice or experience in infants who undergo massages compared to those who do not.
Eligibility Criteria
Inclusion Criteria: * Neonates (age \<1 year) who were undergoing frenotomy procedure are eligible. Exclusion Criteria: * Patients will be excluded if they were older than 1 year, or had palatal or oropharyngeal conditions that may present confounding effects on their ability to feed, including cleft lip and cleft palate.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07738185 clinical trial?
This trial is open to participants of all sexes, up to 1 Year, studying Ankyloglossia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07738185 currently recruiting?
Yes, NCT07738185 is actively recruiting participants. Contact the research team at dlm789@gmail.com for enrollment information.
Where is the NCT07738185 trial being conducted?
This trial is being conducted at Boynton Beach, United States.
Who is sponsoring the NCT07738185 clinical trial?
NCT07738185 is sponsored by Isaac Elijah. The trial plans to enroll 150 participants.