Cleft Palate
Conditions
Interventions
This is a three-arm, double-blind, randomized controlled clinical trial. A total of 70 people who meet the eligibility criteria will be randomly allocated on the day of the surgical procedure to the t
Control group (n=24) (alveolar bone graft surgery)
Placebo group (n=23) (alveolar bone graft + simulated application of transdermal systemic photobiomodulation therapy, with the device emitting sound signals, but without delivering light)
E07.632.490
Sponsors
Hospital de Reabilitação de Anomalias Craniofaciais da Universidade de São Paulo
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Eligibility
Age
9 Years to 25 Years
Inclusion criteria
Inclusion criteria: Have a bilateral transforamen cleft and be able to undergo secondary or tertiary alveolar bone graft surgery with a donor area from the iliac crest
Exclusion criteria
Exclusion criteria: Do not accept participation in the research and/or withdraw from any of its stages; positive test for SARS-cov 2; Modifications in the surgical plan at the time of surgery; presence of a beard or mustache at the time of image acquisition, in order not to compromise the analysis of facial temperature; black patients due to the presence of a greater amount of melanin on the surface of the skin, since the red laser is absorbed by this chromophore and may cause burns with the dose used and standardized for research participants; patients with systemic compromise and not suitable for surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of transdermal systemic photobiomodulation on pain in the immediate postoperative period using a visual analogue scale and over the course of one week postoperatively through WhatsApp messages in which patients will assign scores from 0 to 3 (0- no pain; 1- slight pain; 2- considerable pain; 3 the pain could not be worse) for pain at the time they are asked. It is expected that laser therapy will bring about a reduction in pain perception at different analysis times, both 24 hours after surgery and throughout the week. To this end, we will adopt a significance level of 5%.;To evaluate the effect of transdermal systemic photobiomodulation on facial edema. Edema will be measured based on measurements obtained from the patient's face pre- and post-operatively, using a measuring tape, generating an edema coefficient for each patient. During the weekly assessment, the analysis of the perception of reduction in edema will be carried out via Whatsapp messages, assigning scores from 0 to 3 (0 with no perception of reduction, 1 with a slight decrease; 2 with a moderate decrease and 3 with a considerable decrease in swelling). A significant decrease in edema is expected for the Test group at both times, 24 hours postoperatively and in the weekly analysis. To this end, we will adopt a significance level of 5%.;To evaluate the effect of transdermal systemic photobiomodulation on facial temperature. Facial temperature will be analyzed using infrared thermography. A higher facial temperature is expected in the groups that received the application of systemic photobiomodulation as it favors blood circulation. To this end, we will adopt a significance level of 5%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the correlation between pain, edema and facial temperature. It is expected to find a positive positive correlation between the variables regardless of the treatment applied. | — |
Countries
Brazil
Contacts
Public ContactAna Lúcia de Almeida
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Outcome results
None listed