Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 15, 2023

Primary Completion Date

February 20, 2024

Study Completion Date

February 20, 2024

Conditions
Fear Needles
Interventions
DEVICE

Photobiomodulation

"Photobiomodulation was applied before the procedures at an infrared wavelength of 808nm, at a power of 100mW, 1 point with a total energy of 8J, time of 80s, irradiance of 3.33W/cm² and radiant exposure of 266.66 J/cm2. The application point was on the retromolar region where the needle was inserted to perform the anesthetic, in a single application before the procedure.~The patient and operator were properly protected with goggles in both the control and experimental groups."

DRUG

Mepivacaine hydrochloride in combination with epinephrine

"The anesthetic of choice will be Mepivacaine, which is widely used in dentistry with duration between 1.5 and 2 minutes. The maximum recommended dose is 6.6 mg/Kg, not exceeding 400 mg or 11 anesthetic tubes.~It is a sterile injectable solution of 2% mepivacaine hydrochloride (20 mg/mL) in combination with epinephrine 1:100,000 (0.01 mg/mL). Each vial contains 1.8 mL, 36 mg of mepivacaine hydrochloride, and 0.018 mg of epinephrine. All patients will use anesthetics from the same brand (DLA Pharmaceutical LTDA), one of the most widely used on the market. All patients will be anesthetized with tubes from the same batch, one tube per procedure."

DEVICE

Photobiomodulation simulation

The participants will be treated in the same manner as in group A. The person responsible for the application of FBM will simulate the irradiations by placing the device in the same location described for the experimental group, but the equipment will remain turned off. To prevent the participant from identifying their group, the activation sounds of the devices (beeps) will be recorded to simulate the device's operation.

Trial Locations (1)

01525-000

Anna Carolina R.T. Horliana, São Paulo

All Listed Sponsors
lead

University of Nove de Julho

OTHER