NCT03814525

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

Status unknown Phase 2 Last updated 24 January 2019

What this trial tests

Phase 2 trial testing Photobiomodulation in Maxillary Diseases in 72 participants. Status unknown.

Timeline

2 January 2019

Primary endpoint
30 January 2021

28 February 2021

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	72
Start date	2 January 2019
Primary completion	30 January 2021
Estimated completion	28 February 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Photobiomodulation
• Placebo Photobiomodulation

Conditions studied

• Maxillary Diseases — all drugs for Maxillary Diseases →

Sponsor

University of Nove de Julho

Who can join

Adults 18 to 45, any sex, with Maxillary Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of photobiomodulation effects on pain, edema, paresthesia, and bone regeneration after surgically assisted rapid maxillary expansion: Study protocol for a randomized, controlled, and double blind clinical trial.
   da Fonseca EV, Bussadori SK, da Silva Martinho LFC, de Sousa Melo MC, et al · · 2019 · cited 10× · PMID 31770194 · DOI 10.1097/md.0000000000017756