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

Overview

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.

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. The senior otolaryngologist who will perform the frenotomies will collect data on the initial and follow-up grade of the ankyloglossia using the Appearance Items of the Hazelbaker Assessment Tool for Lingual Frenulum Function. This is a 10-point scale that was previously validated, with lower scores representing more severe ankyloglossia and a score of less than eight being an indication for frenotomy. Recurrence of ankyloglossia is defined as a Hazelbaker Appearance score \<8 at follow-up in conjunction with clinical restriction of tongue mobility as assessed by the examining otolaryngologist. The same individual will record initial and follow-up feeding practices using a standardized 5-item questionnaire adapted from Bhandarkar et al. The questions on the questionnaire are "How are you feeding the baby (breast, bottle, or both)," "How much breast and nipple pain are you having when breast feeding," How difficult is it for your baby to latch onto the nipple when feeding," "How difficult is it to feed your baby in general," and " How satisfied are you with the baby's feeding experience?" The final four items are rated on a scale of one to ten. Resolution of feeding difficulties is defined as improvement in the composite feeding score derived from the 4 Likert-scale questions (pain, latch difficulty, feeding difficulty, and satisfaction). Each item is rated on a 1-10 scale, and changes will be analyzed both individually and as a composite mean score. Given the absence of a validated cutoff for 'resolution,' improvement will be defined as a clinically meaningful reduction in difficulty scores (≥50% reduction from baseline) and/or near-minimal symptom scores (≤2 on Likert scale) at follow-up. The primary outcome wll be the recurrence of ankyloglossia as defined by the Hazelbaker Assessment Tool for Lingual Frenulum Function. Secondary outcomes include the quality of feeding as evaluated by the questionnaire. The outcome measures will be compared between the two groups and Fisher exact test will be employed (p \< 0.05 was considered significant).