Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants
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|ClinicalTrials.gov Identifier: NCT04487418|
Recruitment Status : Unknown
Verified July 2020 by Sandra Kalil Bussadori, University of Nove de Julho.
Recruitment status was: Not yet recruiting
First Posted : July 27, 2020
Last Update Posted : July 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lingual Frenum High Power Laser Breast Feeding||Procedure: Electro cautery surgery Procedure: High power diode laser surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants - Blinded Randomized Controlled Clinical Study|
|Estimated Study Start Date :||September 3, 2020|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||November 3, 2021|
Experimental: Surgery group with electro cautery
Surgery will be performed with electro cautery.
Procedure: Electro cautery surgery
Pre-anesthetics with therapeutic topic (benzocaine) will be administered and, as an anesthetic, or use of anesthetic drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline).
The surgery will be carried out with cauterization for incision of the lingual brake, division of the brake fibers and release, removing the brake fibers that are stored in the anterior ventral free parts of the tongue until reaching the base of the tongue, which are removed or cleaned, lingual movement, and the anterior axis of the tongue is repositioned or lingual brake in that region. No sutures will be performed and should be oriented on the formation of a pseudo-membranous repair plate in the second intention that will be formed between the first and the third day after surgery.
Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.
Experimental: High level diode laser surgery
High power diode laser surgery will be performed.
Procedure: High power diode laser surgery
Pre-anesthetics with therapeutic topic (benzocaine) and as anesthetic or use of anesthetic eye drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline) will be administered. The surgery will be performed with a high power diode laser (TW Surgical, MMOptics - São Carlos - Brazil). 808 nm wavelength, which can be operated in continuous or interrupted mode. Wattages from 1 to 1.5 W, up to a maximum of 2 W, can be used and must carefully respect the histological characteristics of the target tissue and the signs of overheating and carbonization, so that the choice of parameters is dynamic and very dependent on experience, mastery and care for the operator.
Preoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.
- Photograph of the lingual brake region [ Time Frame: 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 [ Time Frame: 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.
- Visual analogue scale (VAS) [ Time Frame: 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.