Clinical trial NCT04487418: Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
Official title: Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants - Blinded Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lingual Frenum
High Power Laser
Breast Feeding
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 56
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin lingual frenulum that can restrict the movements of the tongue and has been identified as one of the factors that can negatively interfere with breastfeeding, decreasing the ability of the newborn to make a clamp proper. According to the Ministry of Health in Brazil, the percentage of newborns who present this anomaly is 3% to 16%. The objective of the study will be to evaluate the release of the lingual frenulum through the lingual frenotomy performed with a high level diode laser or with an electro cautery. Methods: The present study will be a blind randomized controlled clinical trial, in which 56 volunteers, infants aged 0 to 3 months, with normal health status, who are breastfeeding, diagnosed with ankyloglossia and indication for surgery, will do lingual frenotomy. Those responsible for the children will be informed about the study procedures and after signing the Free and Informed Consent Form, authorizing them to participate in the study. The non-blinded researcher will conduct the evaluation, screening and procedures, and another blinded researcher will be the evaluator 15 days after the procedure. The distribution of volunteers in the groups will be random and randomized: Surgery Group with electro cautery (G1- EC) and Surgery Group with high power diode laser (G2-L). The procedures for patient preparation, asepsis and infection control will be strictly followed in accordance with biosafety rules. In both groups the infants will be submitted to anamnesis, clinical evaluation and standardized photograph of the lingual frenulum region before the surgical procedure and application of the Bristol frenulum evaluation protocol, the nursing mother will be submitted to the evaluation of the VAS of pain during breastfeeding, before, shortly after and 15 days after the surgical procedure for the evaluation of the result of the lingual frenotomy. Discussion: Ankyloglossia can negatively impact breastfeeding. The lingual frenotomy procedure can be performed using various surgical techniques. The use of high-power laser for this purpose has been identified as an effective resource in the incision of the lingual frenulum, with advantages in the trans-operative period, less bleeding and better visualization of the surgical field, and in the post-operative period, with reduction of edema, pain and inflammation, quality of tissue repair and patient comfort.


Eligibility criteria: Inclusion Criteria:

* 0 to 3 months old
* Infants born within normal health standards
* Infants who are breastfeeding
* Have a diagnosis of ankyloglossia with a score of 0 to 4 according to the Bristol protocol, performed by a Speech Therapist and / or Dental Surgeon and / or Pediatrician.

Exclusion Criteria:

* Infants with changes:
* Congenital and systemic
* Blood dyscrasias
* Hemophilia, diabetes
* Nutritional weaknesses
* Imunodeficiencies
* Changes in the oral cavity
* Infants who are under medical treatment
* Use of medication
* Do not be well on the day of the surgical procedure.

Primary outcomes:
measure: Photograph of the lingual brake region
timeFrame: 10 minutes
measure: BRISOL
timeFrame: 15 minutes
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Mazzoni A, Navarro RS, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA, Motta PB, Silva T, Gomes AO, Martimbianco ALC, Sobral APT, Santos EM, Motta LJ, Bussadori SK. Evaluation of the effects of high-level laser and electrocautery in lingual frenectomy surgeries in infants: protocol for a blinded randomised controlled clinical trial. BMJ Open. 2021 Nov 30;11(11):e050733. doi: 10.1136/bmjopen-2021-050733.