The Impact of Post-Frenotomy Massages on Ankyloglossia Recurrence and Feeding Outcomes: A Prospective Randomized Trial

This will be a single-center, unblinded, randomized trial in which the use of postoperative massages will be compared with no massages in neonates after frenotomy. The trial will be initiated by the investigators and has been approved by the Institutional Review Board at Florida Atlantic University (IRB2411367). Neonates (age <1 year) who will undergoing frenotomy procedure will be eligible. Patients will be excluded if they are 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. Written informed consent will be obtained from each patient's legally authorized representative.

Patients will be randomly assigned to either the control arm or the study arm in a 1:1 ratio. Randomization will be performed with the use of a random number generator. Given the nature of the intervention, clinicians and research personnel will be aware of the trial-group assignments after randomization.

All infant lingual frenotomies will have been performed in the outpatient clinic by a fellowship-trained pediatric otolaryngologist using a standardized technique. Infants will be swaddled and positioned supine without general anesthesia. The tongue will be elevated using a grooved director to place the lingual frenulum under tension, and release will be performed using a monopolar insulated electrosurgical microdissection needle (Colorado® Micro Dissection Needle, Stryker, Kalamazoo, MI) set to a low-power cutting mode (8 W). The frenulum will be divided from anterior to posterior until adequate release is achieved. Hemostasis will be achieved with cautery alone without sutures. Active procedural time is typically under 10 seconds, and infants will be immediately returned to their caregiver and encouraged to feed following the procedure.

For patients assigned to the massage group, 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.

For patients assigned to the control group, parents/guardians will be instructed not to touch the operative site and to allow the natural motion of tongue while the infant feeds. All patients will be instructed to follow up in the office with the senior otolaryngologist two months after the procedure.