Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction

University of Nove de Julho

Status and phase: Unknown; Phase 2

Conditions: Maxillary Diseases

Treatments: Radiation: Placebo Photobiomodulation; Radiation: Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03814525

Eduardo

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.
• Smokers.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Photobiomodulation group

Active Comparator group

Description:

PBM will be applied after the surgeries with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.

Treatment:

Radiation: Photobiomodulation

Control group

Placebo Comparator group

Description:

Participants will be attended in the same way as the PBM group. The person who is responsible for the application of the PMB will simulate the irradiations by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off.

Treatment:

Radiation: Placebo Photobiomodulation