Tongue Tie Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: f
View:

• Neonates (age \<1 year) who were undergoing frenotomy procedure are eligible.

Locations
United States
Florida
ENT Specialists
RECRUITING
Boynton Beach
Contact Information
Primary
David L Mandell, MD
dlm789@gmail.com
(561) 736-8141
Time Frame
Start Date: 2025-01-27
Estimated Completion Date: 2027-05
Participants
Target number of participants: 150
Treatments
Experimental: Massage Arm
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.
No_intervention: Control Arm
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.
Related Therapeutic Areas
Sponsors
Leads: Isaac Elijah

This content was sourced from clinicaltrials.gov