Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.
Scientific and Technological Institute of the University Brazil, São Paulo, Brazil.
BMJ Open. 2021 Nov 30;11(11):e050733. doi: 10.1136/bmjopen-2021-050733.
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.
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.
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.
NCT04487418.
舌系带过短（俗称舌系带紧）是一种异常情况，其特征是舌系带异常短、厚或小，限制了舌头的运动。这种情况被认为是妨碍母乳喂养的因素之一，因为它会降低新生儿充分衔乳的能力。据巴西卫生部称，这种异常在新生儿中的发生率为 3%-16%。舌系带切开术是治疗舌系带过短的最适宜手术。本研究旨在比较电刀和高功率二极管激光作为舌系带切开术的两种方式。
本研究将是一项随机、对照、盲法临床试验，涉及有母乳喂养困难和舌系带过短诊断且需要行舌系带切开术的健康 0-3 个月龄婴儿。监护人将获得有关程序的说明，并通过签署知情同意书授权婴儿参与。一位非盲研究人员将进行筛选和程序操作，一位盲研究人员将进行术后评估。56 名婴儿将随机分为两组（n=28）：电刀组或高功率激光组。患者准备、无菌和感染控制程序将严格遵循生物安全规范。对于两组患者，将进行病史采集、临床评估，并在手术前拍摄舌系带的标准照片。将使用布里斯托舌评估工具。我们将在手术前、手术后立即和手术后 15 天评估母亲在母乳喂养过程中的疼痛。
本方案已提交给 Nove de Julho 大学的研究伦理委员会，并获得了有利意见（编号：4387769）。结果将提交给国际同行评议期刊，并在国际会议上发表。
NCT04487418。
