Ankyloglossia oral frenectomy
Conditions
Interventions
The sample consists of 60 participants per group: 30 for the intervention group, which underwent immediate irradiation with a low-power diode laser, 1J, red, 660nm, 3 points, and 30 for the control gr
immediate irradiation with either the low-power diode laser or the placebo laser followed
the low-power laser applicator was blinded to the type of laser being used, as they were identified by letters, and both emitted a red light, with one serving only as a guide light, randomization was
research participants were blinded, and the laser used was identified by letters, with both emitting red light
participants from both groups are required to attend follow-up appointments at 7 days and 1 month
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Faculdade de Odontologia da Universidade de São Paulo
Eligibility
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: Patients aged 0 to 1 year, of both sexes, and regardless of race or social class; Patients diagnosed with ankyloglossia according to one of those techniques: TABBY technique (total score equal to 0 to 3) and Lingual Frenulum Evaluation Protocol for Infants (Tongue-tie Test) (Clinical exam: total score 1 to 4 = 7; total score of clinical exam and medical history = 13); Patients whose feeding method is breastfeeding, either naturally or via artificial nipple, with or without the introduction of complementary feeding
Exclusion criteria
Exclusion criteria: Presence of systemic problems and insufficient score on diagnostic tests (Tongue-tie and Breastfed Babies Assessment Tool and Tongue Frenulum Assessment Protocol in Babies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1 - Less postoperative pain symptoms are expected when irradiated with low-power diode laser, compared to when irradiated with placebo laser; this will be verified through data collection using the Neonatal Infant Pain Scale and the amount of medication administered over 7 days;Found outcome 1 - Using the Mann-Whitney statistical test, assuming a type I error of 5%, a statistically significant difference was found according to the NIP scale on days 5 (p=0.007), 6 (p=0.047), and 7 (p=0.047); regarding medication administration, a statistically significant difference was found on day 6 (p=0.024), showing lower pain levels in infants who received low-level laser therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2 - It is expected to see a better degree of postoperative repair when irradiated with low-power diode laser, than when irradiated with placebo laser, this will be verified through photographs taken after 7 days and 1 month, with evaluations conducted by two blinded and calibrated examiners;Found outcome 2 - Using Fisher’s Exact Test, no statistically significant differences were found regarding examiner 1; however, for examiner 2, statistically significant differences were observed between groups on day 7 (p=0.043) and at the 1-month follow-up (p=0.006);Expected outcome 3 - It is expected to obtain improvement in postoperative breastfeeding when lingual frenectomy is performed, with the data being obtained through reevaluation by diagnostic tests, obtaining a lower score for the Lingual Frenulum Assessment Protocol in Babies and a higher score for the Ankyloglossia Assessment Protocol in Breastfed Babies;Found outcome 3 - Using the Wilcoxon signed-rank test and the effect size was calculated using the 'r' statistic; in the pre- and post-intervention comparison, the Visual Numeric Scale (VNS) showed a significant reduction in pain scores (p = 0.008; effect size = 0.44, moderate);Expected outcome 4 - It is expected to verify the effectiveness of the diagnosis of ankyloglossia in babies with breastfeeding difficulties through the Ankyloglossia Assessment Protocol in Breastfed Babies and the Lingual Frenulum Assessment Protocol in Babies, with the scores obtained in each of the tests being compared;Found outcome 4 - Regarding the numerical scores of the TABBY Protocol and the Protocol for Infants (Part I: Clinical Examination), Fisher's Exact Test revealed significant differences between pre- and post-intervention periods. There was a significant increase in TABBY scores (p < 0.001; effect size = 0.78, large) and a corresponding reduction in scores for the Protocol for Infants; Furthermore, when comparing intervention indications, a s | — |
Countries
BR
Contacts
Public ContactCarolina Gonçalves Garcia
Faculdade de Odontologia da Universidade de São Paulo
Outcome results
None listed