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

NCT07738185 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-03

No results posted yet for this study

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

Interventions

OTHER

Post-frenotomy massage

Participants receiving this intervention 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.

Sponsors & Collaborators

  • Isaac Elijah

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2027-03-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738185 on ClinicalTrials.gov