Clinical trial

Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain: A Double-Blind, Randomized Controlled Clinical Study

Name

5.598.425

Description

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.

Trial arms

Trial start

2023-02-15

Estimated PCD

2024-02-20

Trial end

2024-02-20

Treatment

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.

Arms:

Experimental: Photobiomodulation (Group A)

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.

Arms:

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

Other names:

Local anesthetic

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.

Arms:

Control: Laser Sham (Group B)

Size

Primary endpoint

Pain assessment

Immediately Before anesthesia

Pain assessment

Immediately After anesthesia

Eligibility criteria

Inclusion Criteria: * From 18 to 60 years old * Both genders * Without comorbidities * Who required pterygomandibular anaesthesia for a dental procedure. Exclusion Criteria: * 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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-01-22

1 organization

Organization

University of Nove de Julho