150 Participants NeededMy employer runs this trial

Post-Frenotomy Massages for Tongue-tie

DL
Overseen ByDavid L Mandell, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Isaac Elijah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether massages under the tongue after a frenotomy (a procedure to fix tongue-tie) help prevent the recurrence of tongue-tie. Babies who undergo this procedure will be divided into two groups: one group will receive post-frenotomy massages, and the other will not. Researchers aim to determine if these massages prevent tongue-tie from recurring and if they influence the baby's feeding effectiveness. This trial suits babies under one year old who have had the frenotomy procedure and do not have other conditions affecting their mouth or throat, such as a cleft palate. As an unphased trial, this study offers parents a unique opportunity to contribute to understanding new care methods for their babies.

What prior data suggests that post-frenotomy massages are safe for infants?

Research has shown that massages after a frenotomy (a procedure to cut the tongue-tie) are generally safe for babies. Studies have found no major problems linked to these massages.

One study reported that 33.5% of babies experienced some reattachment of the tongue, but only 15.6% showed any symptoms. This suggests that while the tongue might reattach slightly, it usually doesn't cause issues. Another study found a very low reattachment rate of just 0.66% when massages were used, but it also indicated that more evidence is needed to confirm if massages are necessary.

In summary, current research supports the safety of these massages, with no major adverse events reported.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for post-frenotomy massages because it explores a hands-on technique that could prevent complications after tongue-tie surgery. Unlike standard care, which often relies on natural healing and movement during feeding, this method uses gentle fingertip massages to potentially disrupt scar tissue formation and prevent the tongue-tie from coming back. By encouraging active participation from parents, this approach could lead to a simple, non-invasive way to improve surgical outcomes and enhance infants' feeding experiences.

What evidence suggests that post-frenotomy massages are effective for reducing tongue-tie recurrence?

Research on massages after tongue-tie surgery shows mixed results. In this trial, participants in the Massage Arm will receive massages under their tongues following the frenotomy. Studies have found that tongue-tie can recur in 0.66% to 6.0% of babies after surgery, and some experts suggest massages to prevent this. However, other research indicates that breastfeeding improvements and the recurrence of tongue-tie are similar regardless of massages. Specifically, one study found that massages did not significantly reduce the chance of tongue-tie returning or improve feeding. Due to these mixed findings, further research is needed to determine the true effectiveness of these massages.12356

Are You a Good Fit for This Trial?

This trial is for infants who have had a tongue-tie release procedure (frenotomy). Parents or guardians must give consent. Infants with other health issues or conditions that could affect the study may not be eligible.

Inclusion Criteria

My baby is under 1 year old and is having a frenotomy.

Exclusion Criteria

I have a mouth or throat condition like cleft lip or palate that affects my ability to eat.
I am older than 1 year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants undergo frenotomy followed by either sublingual massages or no intervention

1 week
1 visit (in-person)

Follow-up

Participants are monitored for recurrence of ankyloglossia and feeding outcomes

8 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Post-frenotomy massage

Trial Overview

The study compares two groups of infants after frenotomy: one group receives regular sublingual massages under a set schedule, while the other group does not receive any massages. The goal is to see if massages lower the chance of tongue-tie coming back and improve feeding.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Massage ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Isaac Elijah

Lead Sponsor

Citations

Identification and Management of Ankyloglossia and Its ...

The consequences of not using postfrenotomy stretching or massage can lead to repeat adherence of the frenula and require repeat procedure to ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35716239/

Post Frenotomy Massage for Ankyloglossia in Infants-Does ...

Conclusions: Improvement in breast feeding and recurrence after frenotomy were similar between massage and non-massage groups. This confirms the ...

The Impact of Post-Frenotomy Massages on Ankyloglossia ...

This purpose of this study is to investigate whether performing sublingual massages after frenotomy reduces the recurrence of ankyloglossia ...

Outcomes of stretching exercises after lingual frenotomy in ...

Ankyloglossia recurrence is estimated to occur in 0.66 %–6.0 % of infants who undergo frenotomy … 38 % recommend massaging/stretching the wound after frenotomy

Readhesion of Tongue-Tie Following Neonatal Frenotomy

Conclusions: Readhesion of tongue-tie was higher than previously published (33.5%); however, symptomatic readhesion was less frequent (15.6%).

The Impact of Post-Frenotomy Massages on Ankyloglossia ...

This purpose of this study is to investigate whether performing sublingual massages after frenotomy reduces the recurrence of ankyloglossia ...