Recruiting

Sublingual Massages

Sponsor:

Isaac Elijah

Code:

NCT07738185

Conditions

Ankyloglossia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Post-frenotomy massage

Study Details

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

Study ID

NCT07738185

Start date

Jan 27, 2025

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David L Mandell, MD

(561) 736-8141dlm789@gmail.com

Locations

ENT Specialists

Recruiting

Boynton Beach, Florida, United States, 33437

Contacts

David L Mandell, MD

(561) 736-8141dlm789@gmail.com

More Information

Sponsor

Isaac Elijah

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Frenotomy
  • Ankyloglossia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Isaac Elijah on 2026-08-03.