NCT04487418

Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants

Status unknown NA Last updated 27 July 2020

What this trial tests

NA trial testing Electro cautery surgery in Lingual Frenum in 56 participants. Status unknown.

Timeline

3 September 2020

Primary endpoint
1 September 2021

3 November 2021

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	56
Start date	3 September 2020
Primary completion	1 September 2021
Estimated completion	3 November 2021

Drugs / interventions tested

• Electro cautery surgery
• High power diode laser surgery

Conditions studied

• Lingual Frenum — all drugs for Lingual Frenum →
• High Power Laser — all drugs for High Power Laser →
• Breast Feeding — all drugs for Breast Feeding →

Sponsor

University of Nove de Julho

Who can join

Under 3 Months, any sex, with Lingual Frenum or High Power Laser. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of the Effects of High-Power Diode Laser and Electrocautery for Lingual Frenectomy in Infants: A Blinded Randomized Controlled Clinical Trial.
   Mazzoni A, Navarro RS, Fernandes KPS, Mesquita-Ferrari RA, et al · · 2022 · cited 10× · PMID 35807068 · DOI 10.3390/jcm11133783
2. Evaluation of the effects of high-level laser and electrocautery in lingual frenectomy surgeries in infants: protocol for a blinded randomised controlled clinical trial.
   Mazzoni A, Navarro RS, Fernandes KPS, Horliana ACRT, et al · · 2021 · cited 4× · PMID 34848514 · DOI 10.1136/bmjopen-2021-050733