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

NCT03814525 | Unknown Phase 2

• 1 other identifier: Eduardo
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Diseases

Outcome Measures

Primary Outcomes (4)

• Change in Pain

  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.

  After 1, 2, 7 and 14 days of surgeries.

• Change in Edema

  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

  After 1, 2, 7 and 14 days of surgeries.

• Change in intra and extraoral sensitivity

  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.

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

• Change in postoperative bone repair

  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.

  After 30, 60, 90 and 120 days of surgeries.

Secondary Outcomes (9)

• Change in temperature

  After 1, 2, 7 and 14 days of surgeries.

• Presence of headache

  After 1, 2, 7 and 14 days of surgeries.

• Presence of bruises

  After 1, 2, 7 and 14 days of surgeries.

• Presence of otalgia

  After 1, 2, 7 and 14 days of surgeries.

• Presence of nausea

  After 1, 2, 7 and 14 days of surgeries.

Study Arms (2)

Photobiomodulation group

ACTIVE COMPARATOR

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.

Radiation: Photobiomodulation

Control group

PLACEBO COMPARATOR

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.

Radiation: Placebo Photobiomodulation

Interventions

Photobiomodulation RADIATION

PBM will be applied 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.

Photobiomodulation group

Placebo Photobiomodulation RADIATION

The person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Conjunto Hospitalar do Mandaqui

São Paulo, São Paulo, 02402-500, Brazil

RECRUITING

Related Publications (1)

• da Fonseca EV, Bussadori SK, da Silva Martinho LFC, de Sousa Melo MC, de Andrade FL, Goncalves MLL, Mesquita-Ferrari RA, Horliana ACRT, Fernandes KPS. 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. Medicine (Baltimore). 2019 Nov;98(48):e17756. doi: 10.1097/MD.0000000000017756.

  PMID: 31770194 DERIVED

MeSH Terms

Conditions

Maxillary Diseases

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The pre and postoperative evaluations will be done by two examiners who will not be aware of the group in which each patient is allocated. The information that will be obtained in the evaluations will be noted in the clinical evaluation card. Participants will not be aware of whether or not they have received the FBM, since the person responsible for the application will position the equipment in the irradiation locations in all participants and will only trigger the light when and where predicted in the specific experimental group. The characteristic sound of the device will be triggered by recording in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 24, 2019
• Study Start: January 2, 2019
• Primary Completion: January 30, 2021
• Study Completion: February 28, 2021
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

BR (1)