Abstract
BACKGROUND: Ankyloglossia can impair vital functions such as breastfeeding, swallowing, and maxillomandibular development, making effective treatment essential. This study aimed to compare the clinical effectiveness of diode laser (DL) and scalpel (SC) frenotomy in infants with severe ankyloglossia. METHODS: This randomized, parallel, double-blind clinical trial evaluated the efficacy of diode laser surgery compared to conventional scalpel frenotomy in infants aged 0-6 months, all diagnosed with severe ankyloglossia (BTAT score 0-3) (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 diode laser (DL) and scalpel (SC) 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 SC group demonstrated superior breastfeeding performance (LATCH: p = 0.003; IBFAT: p = 0.024). Both groups exhibited reduced pain and progressive healing (p < 0.001). In the diode laser group, a negative correlation was found between total energy applied and healing quality at 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.