A simple massage might stop Tongue-Tie from returning
NCT ID NCT07738185
First seen Jul 31, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This trial tests whether gentle massages under the tongue after a frenotomy (tongue-tie release) can prevent the condition from recurring. Infants under one year who have had the procedure will be randomly assigned to receive the massage routine or no massage. The study will compare recurrence rates and feeding experiences between the two groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Post-frenotomy sublingual massage
- What this could lead to
- If effective, this simple massage routine could become a standard home care practice to prevent tongue-tie recurrence and improve feeding outcomes in infants after frenotomy.
- What could go wrong
- This is a small, early-stage trial, and the massage may not significantly reduce recurrence or improve feeding. There is also a risk of discomfort or complications if not performed correctly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 1 year
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Ankyloglossia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
ENT Specialists
RECRUITINGBoynton Beach, Florida, 33437, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tongue-Tie surgery in infancy: do feeding, speech, and sleep problems return later?
- Can a new device make Tongue-Tie release easier and gentler?
- Tongue-Tie and breastfeeding: a closer look at the first six months
- A Drug-Free tongue workout may help people speak more clearly
- New tool aims to make Tongue-Tie release easier on babies
- Laser vs. electrocautery: which Tongue-Tie fix heals faster?