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

ConditionAnkyloglossia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeUp to 1

SponsorIsaac Elijah

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Post-frenotomy massage
Other intervention
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.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Massage ArmExperimental treatment 1 intervention

Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

Ankyloglossia Recurrence

The primary outcome was the recurrence of ankyloglossia (tongue-tie) upon two month follow-up as defined by the Hazelbaker Assessment Tool for Lingual Frenulum Function.

Time frame

From enrollment to follow-up at 8 weeks.

Secondary outcomes

Feeding Experience

Secondary outcomes included the quality of feeding as evaluated by the previously described questionnaire. The unabbreviated scale title is "Feeding Outcomes Questionnaire." The minimum value is 0. The maximum value is 40. Higher values correlate to worse feeding experience.

Time frame

From enrollment to follow-up at 8 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Isaac Elijah

Lead sponsor

Florida Atlantic University

Sponsor institution

Source ClinicalTrials.gov

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