Clinical trial NCT06128590: Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain
Official title: Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain: A Double-Blind, Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear Needles
Keywords: photobiomodulation, local anesthesics
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

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)

Primary outcomes:
measure: Pain assessment
timeFrame: Immediately Before anesthesia
measure: Pain assessment
timeFrame: Immediately After anesthesia
Secondary outcomes:
measure: Anxiety assessment using Beck's questionnaire
timeFrame: Immediately Before anesthesia
measure: Anxiety assessment using Beck's questionnaire
timeFrame: Immediately After anesthesia
measure: Latency time
timeFrame: Immediately Before anesthesia
measure: Latency time
timeFrame: 2 minutes after anesthesia
measure: Latency time
timeFrame: 5 minutes after anesthesia
measure: Latency time
timeFrame: 10 minutes after anesthesia
measure: Latency time
timeFrame: 15 minutes after anesthesia
measure: Latency time
timeFrame: 20 minutes after anesthesia
measure: Latency time
timeFrame: 25 minutes after anesthesia
measure: Latency time
timeFrame: 30 minutes after anesthesia
measure: Assessment of blood pressure
timeFrame: Immediately Before anesthesia
measure: Assessment of blood pressure
timeFrame: 10 minutes after anesthesia
measure: Blood oxygen saturation level
timeFrame: Immediately Before anesthesia
measure: Blood oxygen saturation level
timeFrame: 10 minutes after anesthesia
measure: Pterygomandibular technique success rate
timeFrame: Immediately After procedure
measure: Suplementar anesthesia
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Anna Carolina R.T. Horliana
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Anna Carolina Horliana, PhD
role: STUDY_DIRECTOR
References: