Evaluation of Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction: Double Blind, Randomized and Controlled Clinical Trial

University of Nove de Julho1 site in 1 country72 target enrollmentJanuary 2, 2019

ConditionsMaxillary Diseases

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Maxillary Diseases
Sponsor: University of Nove de Julho
Enrollment: 72
Locations: 1
Primary Endpoint: Change in Pain
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the present study will be to evaluate the efficacy of photobiomodulation (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life arising after maxillar surgical disjunction (MSD). A randomized, double-blind, placebo-controlled clinical trial involving 72 participants aged 18 to 45 years, who search the Service of Oral Maxillofacial Surgery and Traumatology of the Mandaqui Hospital Complex to undergo MSD, attend to the eligibility criteria and agree to participate. Surgeries will be conducted by three oral maxillofacial surgeons who will perform all surgical procedures, two examiners (who will perform pre and post-surgical evaluations, blinded to the experimental group) and another researcher who will perform the LED application. Before the surgeries, facial measures, radiographic examinations, tests of facial and oral sensitivity and the evaluation of the level of anxiety of all the participants will be carried out. Immediately after the surgeries, the participant will be inserted into the placebo group or the LED group, according to block randomization defined previously. In the LED group, the participants will receive PBM with an extraoral device (660 and 850 nm with 6J per point) and an intraoral one (660 nm with 2J per point) and in the control group the participants will be attended in the same way, but with the LED devices kept off. The applications will be in the immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days after the end of the surgeries, when the evaluations will also be performed. Facial measurements, extra and intraoral sensitivity, pain and bone repair will be evaluated. Secondarily, the data regarding the occurrence of headache; otalgia; nausea; bruise; nasolacrimation; epistaxis; dysphagia; systemic and superficial temperature in the operated region; use of analgesics and anti-inflammatories; anxiety and impact of oral health on the participants' quality of life will be computed.

Registry

clinicaltrials.gov

Start Date

January 2, 2019

End Date

February 28, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Nove de Julho

Responsible Party

Principal Investigator

Sandra Kalil Bussadori

Principal Investigator

University of Nove de Julho

Eligibility Criteria

Inclusion Criteria

•Transverse maxillary deficiency ˃ of 5 mm with bilateral posterior crossbite and indication for surgical maxillary disjunction.
•Agree to participate in the study after reading and signing the Term of Consent for Participation in Clinical Research.

Exclusion Criteria

•Transverse maxilla deficiency, with unilateral posterior crossbite.
•Local or systemic alterations that contraindicate surgical intervention or hinder the postoperative period.
•Display photo sensitivity history.
•Possess systemic diseases, chronic pain or neurological and psychiatric disorders.
•Have been using anti-inflammatories, analgesics or bisphosphonates in the past 15 days.
•Pregnant.
•Breastfeeding.
•Participants who present any type of complication during surgery (hemorrhage, operative difficulty), as these cases will not be in the expected pattern for these surgeries. These data will not be part of the statistical analysis but will be described and discussed, as well as possible adverse effects.

Outcomes

Primary Outcomes

Change in Pain

Time Frame: After 1, 2, 7 and 14 days of surgeries.

A Visual Analog Scale (VAS) will be printed on the patient evaluation form and the subjects will be instructed by the evaluator to mark a point in the line of 10 cm, indicating the intensity of their pain after 1,2, 7 and 14 days of the surgeries. For the NRS-101 scale, the evaluators will ask patients to assign a number between 0 (no pain) and 100 (worst possible pain) that best represents the pain they are currently experiencing after 1, 2, 7 and 14 days of surgeries.

Change in postoperative bone repair

Time Frame: After 30, 60, 90 and 120 days of surgeries.

The optical density (OD) of the alveolar bone in the anterior region of the palatine suture, in each experimental period, will be calculated and compared with that obtained in the preoperative radiographic examination.

Change in Edema

Time Frame: After 1, 2, 7 and 14 days of surgeries.

Using a flexible plastic millimeter tape (0.5mm precision), five facial measurements will be taken corresponding to the distances between the points listed below as described by Ristow et al. (2013). Line A - posterior tragus point to the most lateral point of the labial commissure Line B - tragus posterior point to pogonium Line C - posterior tragus point to the lateral corner of the eye Line D - lateral corner of eye to lowest point of jaw angle Line E - lower point of the angle of the mandible (gonio) to the middle of the nasal bone

Change in intra and extraoral sensitivity

Time Frame: After 7, 30, 60, 90 and 120 days of surgeries.

The evaluation of extra and intraoral sensitivity will be performed in 6 regions: below the lower eyelid, cheek, nose wing, upper lip, oral buccal mucosa and oral palatal mucosa on both sides. The tests will be performed sequentially, with a 2 to 3 minute interval between each. The participant will receive instructions on the tests that will be initially performed on the back of his hand so he can become familiar.