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

NCT05924191 | Recruiting

• 1 other identifier: CIRUCU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molar, Third; Photobiomodulation

Keywords

photobiomodulation; corticosteroids; extraction; edema; pain; mouth opening; quality of life; randomized clinical trial

Outcome Measures

Primary Outcomes (3)

• Postoperative Edema baseline

  To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points

  Edema wil be evaluated immediatly before the surgery (baseline)

• Postoperative Edema - 48 hours postoperative

  To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.

  Edema wil be evaluated at 2 postoperative days.

• Postoperative Edema - 7day postoperative

  To evaluate post-surgical edema (Ustun et al, 2003, Mello et al, 2001), 3 measurements will be determined on the patient's face, with a malleable tape measure graduated in mm (millimeters), previously sanitized, as follows: tragus-pogonion; tragus- labial commissure and mandibular angle (gonion)- external corner of the eye (external canthus). The reference points will be marked with indelible dermographic ink and will remain unchanged throughout the post-surgical evaluation period, for this purpose The patient will be asked to ensure the unaltered conservation of those points.

  Edema wil be evaluated at 7 postoperative days.

Secondary Outcomes (20)

• Postoperative Pain baseline

  In this study, the VAS will be used immediately before surgery (Baseline)

• Postoperative Pain - 48 hours

  In this study, the VAS will be used at 2 postoperative days

• Postoperative Pain - 7 days

  In this study, the VAS will be used 7 days before surgery

• Postoperative use of analgesics - baseline

  The amount of analgesics will be recorded in the baseline.

• Postoperative use of analgesics - 7th days

  The amount of analgesics will be recorded after the third postoperative day until the 7th. post-operative day.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group (n=30 surgeries) - the participants will receive the FBM, 1 hour before the surgical procedure, plus 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).).

Device: Photobiomodulation; Drug: Placebo Corticosteroid

Control Group

ACTIVE COMPARATOR

Control group (n=30 surgeries) - patients will receive conventional treatment with Dexamethasone 8 mg (Corodex, Laboratorio Celsius, Montevideo, Uruguay) PO 1 hour before surgery (Almeida et al 2019), plus simulation of FBM application. The Laser device will be disconnected and will be applied to the same points as in the experimental group, in the immediate pre-operative period (Baseline).

Device: Simulation Photobiomodulation; Drug: Corticosteroid

Interventions

Photobiomodulation DEVICE

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.

Experimental Group

Placebo Corticosteroid DRUG

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).).

Experimental Group

Simulation Photobiomodulation DEVICE

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.

Control Group

Corticosteroid DRUG

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

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Kristianne Porta Santos Fernandes

São Paulo, São Paulo, 01525-000, Brazil

RECRUITING

MeSH Terms

Conditions

Edema; Pain

Interventions

Low-Level Light Therapy; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Kristianne PS Fernandes

CONTACT

+5511984612676; kristianneporta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical colaborator

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 29, 2023
• Study Start: November 20, 2023
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

BR (1)