Clinical trial NCT03814525: Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction
Official title: Evaluation of Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction: Double Blind, Randomized and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Maxillary Diseases
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Change in Pain
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Change in Edema
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Change in intra and extraoral sensitivity
timeFrame: After 7, 30, 60, 90 and 120 days of surgeries.
measure: Change in postoperative bone repair
timeFrame: After 30, 60, 90 and 120 days of surgeries.
Secondary outcomes:
measure: Change in temperature
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of headache
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of bruises
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of otalgia
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of nausea
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of nasolacrimation
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of nose bleeding
timeFrame: After 1, 2, 7 and 14 days of surgeries.
measure: Presence of dysphagia
timeFrame: After 7 and 30 days of surgeries.
measure: Postoperative quality of life
timeFrame: After 7 and 30 days of surgeries.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Conjunto Hospitalar do Mandaqui
state: SP
Study officials:
References:
citation: 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.