Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain

University of Nove de Julho

Status: Completed

Conditions: Fear Needles

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06128590

5.598.425

Details and patient eligibility

About

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.

Full description

Dental fear and phobia are widespread worldwide, with local anesthesia being one of the procedures that patients fear the most. To alleviate the pain associated with needle insertion and the need for repeat procedures, various complementary therapies have been introduced. However, to date, there is no established protocol for this intervention. 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. Categorical variables will be presented as absolute and relative frequencies and compared using the Pearson chi-squared test, likelihood ratio test, or Fisher's exact test. Quantitative variables will be assessed for normality using the Kolmogorov-Smirnov test. Outcome variables will be presented as mean and standard deviation or median and interquartile range (IQR) and compared using the Student's t-test or Mann-Whitney test. Variables measured under multiple conditions will be compared using analysis of variance for repeated measures. A significance level of P < 0.05 will be considered statistically significant.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Experimental: Photobiomodulation (Group A)

Experimental group

Description:

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

Treatment:

Drug: Mepivacaine hydrochloride in combination with epinephrine

Device: Photobiomodulation

Control: Laser Sham (Group B)

Sham Comparator group

Description:

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.

Treatment:

Device: Photobiomodulation simulation

Drug: Mepivacaine hydrochloride in combination with epinephrine