High-power diode laser versus conventional scalpel in the surgical treatment of pediatric ankyloglossia: a randomized, parallel, triple-blind, controlled clinical trial

Abstract Background Ankyloglossia can impair vital functions such as breastfeeding, swallowing, and maxillomandibular development, making effective treatment essential. Methods This randomized, parallel, triple-blind clinical trial evaluated the efficacy of high-power diode laser surgery compared to conventional scalpel frenotomy in infants aged 0–6 months (n = 40/group). Patients were assessed at D0 (pre-, trans-, and/or 30 min postoperative), D7, and D14 using specific instruments according to each outcome: tongue repositioning and frenulum release (BTAT and Tongue Test), wound healing (Landry index), perioperative pain (CRIES scale), and breastfeeding performance (body mass variation, LATCH, and IBFAT scales). Results Both the high-power laser (HPL) and scalpel (SCP) groups showed significant functional improvements and weight gain over time (p < 0.001), with no significant intergroup differences in most outcomes (p > 0.05). However, on D7, the SCP group demonstrated superior breastfeeding performance (LATCH: p = 0.003; IBFAT: p = 0.024). Both groups exhibited reduced pain and progressive healing (p < 0.001). A negative correlation was observed between laser energy and healing quality on D14 (r = -0.355; p = 0.027). Conclusions Findings suggest both techniques are clinically effective, but laser parameters may influence healing. Further studies are warranted to optimize laser protocols in pediatric ankyloglossia surgery. Trial registration RBR466cykz November 13th, 2024