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Study aim
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Evaluation of the effect of photobiomodulation using a 970-nm diode laser, combined with a neutral gel, on the perception of pain caused by buccal infiltration anesthesia in the maxillary anterior teeth.
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Design
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Phase II, randomized, single-blind, sham-controlled clinical trial with a 2×2 factorial, four parallel-arm, conducted on 128 patients. Allocation was performed using block randomization with variable block sizes (4 and 8) generated via Sealed Envelope.
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Settings and conduct
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This single-blind randomized trial will be conducted in a dental clinic. Patients are randomly assigned to four groups and receive standardized buccal infiltration anesthesia by one operator. Blinding is achieved using sham laser and neutral gel, making patients unaware of group allocation.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Adults ≥18 years requiring maxillary anterior buccal infiltration anesthesia, ASA I–II, able to complete VAS and DAI.
Exclusion criteria: Refusal of consent, allergy/contraindication to local anesthetics or epinephrine, uncontrolled systemic disease, or infection/inflammation/lesions at the injection site.
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Intervention groups
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Group 1: Active 970-nm diode laser without gel, followed by buccal infiltration anesthesia.
Group 2: Neutral gel + sham laser, then anesthesia.
Group 3: Neutral gel + active laser, then anesthesia.
Group 4: Sham laser without gel (control), then anesthesia.
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Main outcome variables
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1. Pain intensity during needle insertion measured using a 0–10 Visual Analog Scale (VAS).
2. Pain intensity during anesthetic solution injection measured using a 0–10 Visual Analog Scale (VAS).