RecruitingNot ApplicableNCT05924191

Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars

Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars: a Double-blind Randomized Controlled Study


Sponsor

University of Nove de Julho

Enrollment

30 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Third molar extraction is one of the most performed surgical procedures in Dentistry. A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain, edema, and lockjaw. Therefore, the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars.The primary study variable will be postoperative edema measured in millimeters, 48 hours after surgery, and the secondary variables will be: pain, lockjaw, local temperature (measured with a thermographic camera), dysphagia, and the need to ingest nonsteroidal analgesics (Acetaminophen)These variables will be evaluated at the beginning of the study (baseline), at 2 and 7 days post-surgery. All adverse effects will be recorded. The data obtained will be represented by their means ± SD and the p value will be set at 0.05.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Corticosteroid, a medical device called Photobiomodulation, and others for people with molar, third and photobiomodulation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPhotobiomodulation

Intra-oral irradiations wll be performed with a low intensity Laser device at 4 anatomical points, with a wavelength of 660 nm. The extraoral FBM will be applied with 1 cluster (20cm2) with a wavelength of 630nm. Subsequently, the same region will be irradiated with the same cluster, using the 4 LEDs with a wavelength of 850 nm 1 hour before performing the surgery.

DRUGPlacebo Corticosteroid

Participants will receive 1 hour before the surgery a placebo tablet, with the same physical and organoleptic characteristics, composed of corn starch, without harmful effects on health and simulating Dexamethasone (Celsius Laboratory, Montevideo, Uruguay).).

DEVICESimulation Photobiomodulation

The irradiation simulations will be practiced in the same anatomical points described in the experimental group. This protocol will be carried out 1 hour before the surgical procedure (Baseline). The Laser device will be disconnected and its beep sound will be recorded and run on simulating the irradiation.

DRUGCorticosteroid

The patients will receive Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019)


Locations(1)

Kristianne Porta Santos Fernandes

São Paulo, São Paulo, Brazil

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NCT05924191


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