Ankyloglossia
Conditions
Interventions
This is a randomized controlled trial, triple-blind clinical study. Experimental group: 45 babies with ankyloglossia will be operated on with high-power diode laser. Control group: 45 babies with anky
E02.594
Sponsors
Instituto para o Desenvolvimento da Educação Ltda-IPADE/Faculdade
Centro Universitário Christus
Instituto do Câncer do Ceará - ICC
Eligibility
Age
No minimum to 12 Years
Inclusion criteria
Inclusion criteria: Healthy individuals between 0 and 12 years; old male or female; diagnosed with ankyloglossia by a dental surgeon pediatric dentist using the Bristol Tongue Assessment Tool Protocol
Exclusion criteria
Exclusion criteria: Individuals with systemic impairments that contraindicate the surgical procedure such as blood dyscrasias; hemophilia; nutritional deficiency; immunodeficiency; neurological or neuromuscular disorders; undergoing previous pharmacological treatment; with breastfeeding difficulties but without a diagnosis of ankyloglossia; with absolute or relative contraindications to the administration of local anesthetics; with orofacial congenital malformations weight loss greater than 10% of birth weight whose guardians refuse to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the release and repositioning of patients' lingual frenum, determined using the BTAT and Tongue Test ankyloglossia classification scales that will be used both pre- and post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe the impact on the healing process that will be carried out through a quantitative method in the postoperative evaluation (immediate, 7 and 14 days) with the Landry healing index;It is expected to observe the increase in the patient's body mass, using a digital body scale, at the time of the first consultation as well as in post-operative evaluations (immediate, 7 and 14 days);It is expected to evaluate perioperative pain in patients using the C.R.I.E.S scale, which will be the tool of choice to check parameters such as: crying, need for oxygenation, increase in vital signs, facial expression and drowsiness. The parameters will be evaluated by the same operator, preoperatively, intraoperatively, immediately postoperatively and 30 minutes after surgery, also with the aid of a pulse oximeter;For breastfeeding patients, breastfeeding will be assessed using the LATCH (latching, audible swallowing, nipple type, breast comfort and positioning on the lap) and IBTAT (Infant Breastfeeding Assessment Tool) scales. Breastfeeding quality assessments will be carried out pre-operatively (before surgery) and post-operatively (immediately, 7 and 14 days) | — |
Countries
Brazil
Contacts
Public ContactMaria Elisa Lima Verde
Centro Universitário Christus
Outcome results
None listed