This randomized controlled clinical trial evaluates whether adjunctive 808-nm diode laser therapy after direct pulp capping reduces postoperative pain and dentin hypersensitivity compared with conventional Biodentine treatment. Sixty teeth from fifty-six participants with carious pulp exposure were randomly allocated into two treatment groups. Postoperative pain, dentin hypersensitivity, and 6-month clinical success rates were assessed.
Direct pulp capping (DPC) is a vital pulp therapy procedure intended to preserve pulp vitality and stimulate reparative dentin formation after pulp exposure. The clinical success of DPC depends on effective sealing of the exposure site, bacterial control, and maintenance of pulpal health. Bioactive tricalcium silicate-based materials such as Biodentine have demonstrated favorable biological and mechanical properties and are widely used as pulp-capping agents because of their biocompatibility, sealing ability, and dentin-bridge induction potential. Despite the favorable outcomes of modern pulp-capping materials, postoperative pain and dentin hypersensitivity remain common complications following DPC. These symptoms may negatively affect patient comfort, treatment acceptance, and short-term clinical outcomes. Adjunctive use of diode laser therapy has been proposed to improve the biological environment of the exposed pulp by providing hemostasis, antimicrobial action, and photobiomodulation. Experimental and clinical evidence suggests that diode laser irradiation may reduce inflammation, stabilize cell membranes, improve microcirculation, and enhance cellular metabolism through increased adenosine triphosphate (ATP) synthesis, thereby reducing postoperative discomfort and promoting tissue healing. However, evidence regarding the effectiveness of diode laser therapy as an adjunct to DPC remains limited, particularly due to variations in laser parameters, treatment protocols, and pulp-capping materials among previous studies. Therefore, this randomized controlled clinical trial was designed to evaluate the clinical effectiveness of adjunctive 808-nm diode laser therapy following direct pulp capping using Biodentine. A total of 60 teeth from 56 participants diagnosed with carious pulp exposure and fulfilling the eligibility criteria were included. Eligible teeth were randomly allocated into two groups using a computer-generated 1:1 randomization sequence with allocation concealment by sequentially numbered, opaque, sealed envelopes (SNOSE). In the control group, direct pulp capping was performed using Biodentine following conventional hemostasis and disinfection procedures. In the experimental group, adjunctive diode laser therapy (808 nm) was applied for hemostasis and disinfection prior to Biodentine placement, using standardized irradiation parameters. The primary outcomes of the study are postoperative pain intensity and dentin hypersensitivity. Postoperative pain is assessed using the Numerical Rating Scale (NRS, 0-10) and the duration until complete pain resolution is recorded. Dentin hypersensitivity is evaluated at 1, 3, and 6 months using a cold stimulus and NRS scoring. The secondary outcome is the clinical success rate at 6 months, determined by clinical and radiographic criteria including pulp vitality, absence of spontaneous pain, absence of tenderness to percussion, and absence of radiographic periapical pathology. The study hypothesizes that adjunctive diode laser therapy will significantly reduce postoperative pain and dentin hypersensitivity following direct pulp capping compared with conventional Biodentine treatment, while maintaining comparable clinical success rates at 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Biodentine was used as a bioactive tricalcium silicate pulp-capping material placed directly over the exposed pulp tissue following hemostasis and cavity disinfection.
Adjunctive diode laser irradiation was applied for hemostasis and disinfection before Biodentine placement during direct pulp capping.
Department of Odonto-Stomatology, Hue University of Medicine and Pharmacy
Huế, Vietnam
Dentin Hypersensitivity
Dentin hypersensitivity will be assessed using a cold stimulus test (0-4°C water) and recorded using the Numerical Rating Scale (NRS, 0-10), where higher scores indicate greater sensitivity.
Time frame: 1 month, 3 months, and 6 months after treatment
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will record daily pain scores until complete pain resolution.
Time frame: Daily until complete pain resolution (up to 7 days after treatment)
Clinical Success Rate
Clinical success will be evaluated based on pulp vitality, absence of spontaneous pain, absence of tenderness to percussion, absence of pathological mobility, and absence of radiographic periapical pathology.
Time frame: 6 months after treatment
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