Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
- Conditions
- High Power LaserBreast FeedingLingual Frenum
- Interventions
- Procedure: Electro cautery surgeryProcedure: High power diode laser surgery
- Registration Number
- NCT04487418
- Lead Sponsor
- University of Nove de Julho
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery group with electro cautery Electro cautery surgery Surgery will be performed with electro cautery. High level diode laser surgery High power diode laser surgery High power diode laser surgery will be performed.
- Primary Outcome Measures
Name Time Method Photograph of the lingual brake region 10 minutes An intraoral photograph will be performed on the planes: frontal, median sagittal of the patient, parallel to the vertical edges and occlusal to the horizontal edges with the focus on the lingual brake region. The evaluation will be performed after the surgical procedure, and after 15 days.
BRISOL 15 minutes The baby will be placed on the lap of one of the guardians, adult, in the supine position, who in turn is lying in the dental chair, in some situations the knee-to-knee position may be used, and the professional should assess which will be more convenient for stabilization. protective of the patient.
asepsis and infection control for the patient, will be strictly followed in accordance with Biosafety rules.
In the Bristol protocol we will have a final score based on 4 points to observe: appearance of the tip of the tongue, fixation of the brake in the lower alveolus, elevation of the tongue during crying and protrusion of the tongue on the gums The evaluation will be carried out immediately after the surgery and after 15 days.
- Secondary Outcome Measures
Name Time Method Visual analogue scale (VAS) 10 minutes The application of the VAS pain scale will be applied to the nursing mother during breastfeeding before, shortly after and 15 days after the surgical procedure. During breastfeeding, the nursing mother will be asked about the pain in the breasts, and she must report the pain by looking at the scale mentioned, from 0 to 10 and choose the number that most relates to breast pain.