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

Conditions

• Ankyloglossia

Eligibility Criteria

Sex

ALL

Age

N/A - 1 Year

Healthy Volunteers

Not accepted

Interventions

• Post-frenotomy massage — OTHER
  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.

Study Details

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.

Key Dates

First listed

Jul 31, 2026

Start date

Jan 27, 2025

Status verified

Jul 2026

Primary completion

Mar 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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.

Primary Outcome Measure

Ankyloglossia Recurrence [ Time Frame: From enrollment to follow-up at 8 weeks. ]

Central Contacts

• David L Mandell, MD
  (561) 736-8141
  [email protected]

Locations (1)

Find similar trials in Boynton Beach, FL

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