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The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes

The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes: A Prospective Randomized Trial

Who can join

Up to age 1 · All sexes

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.

About the study

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.

What is being tested

• Post-frenotomy massage (other)

Sponsor: Isaac Elijah · Participants: 150 · Started: Jan 27, 2025

Contact the study team

• David L Mandell, MD · Phone: (561) 736-8141

Official record on ClinicalTrials.gov — NCT07738185

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.