Evaluation of the effects of high-level laser and electrocautery in lingual frenectomy surgeries in infants: protocol for a blinded randomised controlled clinical trial.

Introduction: Ankyloglossia (tongue-tie) is an anomaly characterised by an abnormally short, thick or small lingual frenulum that restricts tongue movements. This condition is considered one of the factors that can interfere with breast feeding by diminishing the ability of the newborn to latch adequately. According to the Brazilian Health Ministry, the prevalence of this anomaly among newborns is 3%-16%. Frenectomy is the most suitable surgical procedure for the treatment of ankyloglossia. The aim of this study is to compare the performance of electrocautery and high-power diode laser as forms of frenectomy.

Methods And Analysis: The proposed study will be a randomised, controlled, blind clinical trial involving the participation of healthy infants 0-3 months of age with breastfeeding difficulty and a diagnosis of tongue-tie with an indication for lingual frenectomy. The guardians will receive clarifications regarding the procedures and will authorise the participation of the infants by signing a statement of informed consent. A non-blinded researcher will perform the screening and procedures and a blinded researcher will perform the postoperative evaluations. Fifty-six infants will be randomly allocated into two groups (n=28): the electrocautery group or the high-power laser group. The preparation of the patients, asepsis and infection control procedures will rigorously follow biosafety norms. For both groups, patient histories will be taken, clinical evaluations will be performed and a standardised photograph of the lingual frenulum will be taken before surgery. The Bristol Tongue Assessment Tool will be used. We will evaluate pain in the mother during breast feeding before, immediately after, and 15 days after surgery.

Ethics And Dissemination: This protocol was submitted to the Research Ethics Committee of Nove de Julho University, having been given a favourable opinion (Number: 4387769). Results will be submitted to international peer-reviewed journals and presented at international conferences.

Trial Registration Number: NCT04487418.