Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain

Summary

The objective of this study is to assess whether pre-anesthetic photobiomodulation (PBM) can effectively reduce needle puncture pain and enhance the efficiency of local anesthesia. In this double-blind randomized controlled trial, 50 participants were included. The control group underwent the standard anesthetic procedure, while the experimental group received the application of an infrared laser (100mW at 808nm, 8J at a single point) immediately before anesthesia, at the site of the intended needle puncture. Both groups underwent the same anesthetic procedure, administered by the same operator. The outcome evaluator and the patient were blind to the FBM application. The primary outcome of the study focused on pain experienced at the time of needle insertion, assessed using the Visual Analogue Scale (VAS) during the needle's introduction. Secondary outcomes encompassed anxiety levels, measured using the Beck questionnaire, anesthetic onset time determined through the electric pulp test, the number of anesthetics required for the procedure, and the necessity for supplementary anesthesia.

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.

Sponsors & Collaborators

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Anna Carolina Horliana, PhD · University of Nove de Julho

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-15

Primary Completion

2024-02-20

Completion

2024-02-20

Countries

• Brazil

Study Locations