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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.

ABSTRACT: BACKGROUND:Surgically assisted rapid maxillary expansion (SARME) generates an uncomfortable postoperative period accompanied by pain, edema, and paresthesia. There are few studies on the effect of photobiomodulation (PBM) after SARME and it was not possible to find studies on the efficacy of light emitted by diode (LED) after this type of intervention. The main objective of the study will be to evaluate the efficacy of PBM with LED in the control of pain, facial edema, paresthesia, and bone repair after SARME. METHODS:A randomized, double-blind, placebo-controlled clinical trial involving 72 participants aged from 18 to 45 years, who search the Department of Buccomaxillofacial Surgery and Traumatology of Mandaqui Hospital Complex, will be conducted. Immediately after surgeries, the participant will be inserted into the placebo or LED group. In the LED group, the participants will receive PBM with an extraoral device (660 and 850?nm with 6 J per point) and an intraoral device (660?nm with 2 J per point) and in the control group the person in charge of the application will simulate the irradiation with the 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, data regarding the occurrence of headache; otalgia; nausea; bruising; 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. DISCUSSION:Since PBM has shown positive effects on postoperative complications of other types of oral surgery and also has a positive effect on bone repair after maxillary disjunction, surgically assisted or not, it seems clear the need to evaluate its performance regarding pain, edema, and paresthesia after these surgeries. TRIAL REGISTRATION:This protocol was registered in Clinical Trials platform (https://clinicaltrials.gov/) with the number NCT03814525, first published and last updated on January 24, 2019.

SUBMITTER: da Fonseca EV

PROVIDER: S-EPMC6890349 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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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 Eduardo Vasques EV Bussadori Sandra Kalil SK da Silva Martinho Luiz Felipe Cabral LFC de Sousa Melo Maria Carolina MC de Andrade Felipe Ledo FL Gonçalves Marcela Leticia Leal MLL Mesquita-Ferrari Raquel Agnelli RA Horliana Anna Carolina Ratto Tempestini ACRT Fernandes Kristianne Porta Santos KPS

Medicine 20191101 48

<h4>Background</h4>Surgically assisted rapid maxillary expansion (SARME) generates an uncomfortable postoperative period accompanied by pain, edema, and paresthesia. There are few studies on the effect of photobiomodulation (PBM) after SARME and it was not possible to find studies on the efficacy of light emitted by diode (LED) after this type of intervention. The main objective of the study will be to evaluate the efficacy of PBM with LED in the control of pain, facial edema, paresthesia, and b ...[more]

PMID: 31770194

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Project description:INTRODUCTION:Oral lichen planus (OLP) is an idiopathic chronic mucocutaneous disease with a wide range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. Topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after the discontinuation of treatment as well as developing resistance to corticosteroid therapy. Photobiomodulation (PBM) has been shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. The aim of this study was to compare the efficacy of PBM (660?nm) with corticosteroid therapy with clobetasol propionate 0.05% for the treatment of OLP. METHODS AND ANALYSIS:Forty-four patients with symptomatic and histopathological diagnosis of OLP will be randomised into two experimental groups in a double-blind manner: control group (n=22): clobetasol propionate 0.05%+placebo PBM, and experimental group (n=22): PBM (?=660?nm, power 100?mW, radiant exposure: 177?J/cm2 and 0.5J per point)+placebo?gel. Laser will be applied 2×/week for 1?month and clobetasol propionate three times a day for 30 days and the same for placebo treatments. The primary variable (pain) and the secondary variables (clinical score, evaluation of functional scores, clinical resolution, OLP recurrence, quality of life and anxiety and depression) will be evaluated at the baseline, once a week during treatment (depending on the variables) and after 30 days and 60 days of follow-up. Pain will be evaluated using visual analogue scale and clinical characteristics will be scored using the Thongprasom Index. The quality of life and anxiety and depression will be evaluated by Oral Health Impact Profile-14 questionnaire and by Hospital Anxiety and Depression Scale for anxiety scale, respectively. The serum and salivary levels of interleukin (IL)-6, IL-10, IL-1?, INF-? and tumour necrosis factor-? will be evaluated by ELISA at baseline and at the end of treatment. ETHICS AND DISSEMINATION:This protocol was approved (#2.375.410) by the Nove de Julho University (UNINOVE) Research Ethics Committee. The data gathered using this protocol will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:NCT03320460.

Dataset Information

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.

Publications

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.

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