Post-Frenotomy Massages After Tongue-Tie Procedure
Official title: The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes: A Prospective Randomized Trial
Run by Florida Atlantic University · NCT07738185 · Data updated 2026-11-12
After a frenotomy, this study tests whether giving babies sublingual massages reduces tongue-tie recurrence and improves feeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Florida Atlantic University Academic / other |
| Locations | 1 site (Boynton Beach, Florida) |
| Status | Recruiting |
| Started | January 27, 2025 |
| Main results expected | March 2027 |
| Study ends | May 2027 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT07738185 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are neonates under 1 year undergoing frenotomy for ankyloglossia without additional palatal or oropharyngeal conditions that affect feeding.
✕Probably not a fit
Patients with conditions that impact feeding beyond the tongue-tie or those outside the 1-year age window may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, unblinded trial enrolling neonates undergoing frenotomy for ankyloglossia. Participants are randomized to receive a prescribed massage regimen after the procedure or to receive no massages. The primary aim is to see if post-procedure massages lower recurrence of tongue-tie; secondary aims explore any effects on feeding practices or experiences. The study is conducted with informed consent and IRB approval, using a standardized frenotomy technique performed in an outpatient setting by a pediatric otolaryngologist.
Why it matters
Potential benefit: If successful, massages after frenotomy could reduce recurrent tongue-tie and support feeding outcomes in affected infants.
How similar studies have gone: This approach is novel for post-frenotomy care; prior studies on post-procedure massages for tongue-tie recurrence are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
ENT Specialists
Boynton Beach, Florida, United States Recruiting
Study contacts
- Study coordinator: David L Mandell, MD
- Email: dlm789@gmail.com
- Phone: (561) 736-8141
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.