Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain

NCT06128590 | Completed

• 1 other identifier: 5.598.425
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

photobiomodulation, local anesthesics

Outcome Measures

Primary Outcomes (2)

• Pain assessment

  It will be carried out as follows: the healthcare professional asks the patient to select a point on a line 10cm long, drawn between two extremities to express the intensity of the pain. Patients will be asked to rate "current" pain intensity or, in other cases, pain intensity "in the last 24 hours". The VAS is a simple-to-use assessment tool that does not require sophisticated equipment. It is also highly sensitive in detecting the effects of treatment, and its results can be analyzed using parametric tests. In this study, a plastic band was made for all patients,

  Immediately Before anesthesia

• Pain assessment

  It will be carried out as follows: the healthcare professional asks the patient to select a point on a line 10cm long, drawn between two extremities to express the intensity of the pain. Patients will be asked to rate "current" pain intensity or, in other cases, pain intensity "in the last 24 hours". The VAS is a simple-to-use assessment tool that does not require sophisticated equipment. It is also highly sensitive in detecting the effects of treatment, and its results can be analyzed using parametric tests. In this study, a plastic band was made for all patients,

  Immediately After anesthesia

Secondary Outcomes (16)

• Anxiety assessment using Beck's questionnaire

  Immediately Before anesthesia

• Anxiety assessment using Beck's questionnaire

  Immediately After anesthesia

• Latency time

  Immediately Before anesthesia

• Latency time

  2 minutes after anesthesia

• Latency time

  5 minutes after anesthesia

Study Arms (2)

Experimental: Photobiomodulation (Group A)

EXPERIMENTAL

Participants will receive photobiomodulation therapy immediately before local anesthesia, in the same place where the puncture will be performed for pterygomandibular anesthesia.

Device: Photobiomodulation; Drug: Mepivacaine hydrochloride in combination with epinephrine

Control: Laser Sham (Group B)

SHAM COMPARATOR

The participants will be treated in the same way as in group A. The person responsible for applying the PBM will simulate the irradiations by positioning the device in the same place as described for the experimental group, but the equipment will be switched off. So that the participant does not identify the group to which they belong, the device's activation sound (beep) will be simulated by the device itself, which makes the beep sound by pressing the activation button only once. After this, pterygomandibular anesthesia will be carried out in the same way.

Drug: Mepivacaine hydrochloride in combination with epinephrine; Device: Photobiomodulation simulation

Interventions

Photobiomodulation DEVICE

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.

Experimental: Photobiomodulation (Group A)

Mepivacaine hydrochloride in combination with epinephrine DRUG

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.

Also known as: Local anesthetic

Control: Laser Sham (Group B); Experimental: Photobiomodulation (Group A)

Photobiomodulation simulation DEVICE

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.

Control: Laser Sham (Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• From 18 to 60 years old
• Both genders
• Without comorbidities
• Who required pterygomandibular anaesthesia for a dental procedure.

You may not qualify if:

• Any sign of pain or inflammation at the puncture site (e.g. presence of pericoronaritis)
• Active periodontitis/gingivitis
• Use of a pacemaker
• Use of prostheses, fixed metal appliances
• Using anti-inflammatory, analgesic or corticosteroid therapy for less than 1 week.
• Pregnant and/or breastfeeding women
• Need to use a local anaesthetic other than Mepivacaine with vasoconstrictor (anaesthetic of choice for the study)

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Anna Carolina R.T. Horliana

São Paulo, São Paulo, 01525-000, Brazil

Location

MeSH Terms

Conditions

Iatrophobia

Interventions

Low-Level Light Therapy; Mepivacaine; Epinephrine; Anesthetics, Local

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Anna Carolina Horliana, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for administering FBM will be aware of the assigned interventions for each participant. Participants will remain unaware of the specific treatment they receive, as the treatment is standardized across both groups, with FBM being simulated in the control group. The outcome assessor will also be blinded to the interventions. Group identifications will be revealed only after the statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: To randomly allocate participants into the experimental groups, a draw was conducted with 50 numbers using the Sealed Envelope website: https://www.sealedenvelope.com. The distribution was identical (1:1) for both groups, using a blocked design.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: February 15, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

BR (1)