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

Photobiomodulation Molar, Third

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

Inclusion Criteria6

Patients who present retained lower third molars, according to the degree of surgical difficulty of the procedure and the anatomical position.The selected molars will be those classified according to classes II and III and/or B or C of Pell and Gregory Classification; in vertical or mesio-angular position, according to the Winter Classification or Class II with need for ostectomy or III, with need for ostectomy and odontosection of the Prant Scale, modified by Amarillas-Escobar et al.
That have an indication for the extraction of the lower third molars (due to recurrent infections, bad anatomical position, orthodontic indication) or a professional indication presented in writing and that are healthy (ASA I, with a negative medical history).
Male or female gender.
Age between 18 and 50 years.
Good oral hygiene.
That they agree to participate in the study, after reading and signing the Informed Consent for participation in clinical research.

Exclusion Criteria9

Carriers of local alterations that contraindicate surgical intervention or complicate the postoperative period (example: acute phase pericoronitis in the last 30 days, ankylosis of the temporomandibular joint).
Smokers,
Presenting absence of upper and lower central incisors,
With a medical history of photosensitivity
During pregnancy or lactation,
That they were using anti-inflammatories or analgesics,
Allergic to any of the drugs used in the research (amoxicillin, ketorolac, acetaminophen, dexamethasone, chlorhexidine 2%, local anesthetics, sodium bisulfite, etc.)
That during surgery they present any type of complication (bleeding, transoperative difficulties, etc.), because these cases are not included within the expected pattern behavior for this type of surgery (these cases will be reported),
Surgical time greater than 90 minutes.

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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)