The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes | NCT07738185

NCT07738185

Overview

NCT ID: NCT07738185
Lead Sponsor: Isaac ElijahOTHER
Official Title: The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes: A Prospective Randomized Trial
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.
Conditions: Ankyloglossia

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Jan 27, 2025Actual
Primary Completion Date: Mar 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 150Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: David L Mandell, MDContact
dlm789@gmail.com(561) 736-8141

Similar Studies

Participant Group/Arms

Massage ArmExperimental

Participants randomized to this arm will undergo massages under their tongues after the frenotomy (e.g., tongue-tie cutting procedure) is completed. Parents/guardians will be instructed to wait until postoperative day one before initiating massages. They will be instructed to then perform massages twice per day for seven days by applying gentle pressure with the fingertip in a circular motion around the frenotomy site for at least 10 seconds at a time with the intention of disrupting any developing connective tissue or ankyloglossia recurrence. The parents/guardians will be instructed to keep a log of any missed sessions to bring with them upon follow-up.

Other: Post-frenotomy massage

Control ArmNo Intervention

Participants in this arm will not undergo any massages under their tongues. Parents/guardians will be instructed not to touch the operative site and to allow the natural motion of tongue while the infant feeds.