An interventional study of Biodentine and 808-nm Diode Laser in Dental Pulp Exposure, Postoperative Pain and Dentin Hypersensitivity, sponsored by Hue University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Open to participants aged 10 Years to 58 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Hue University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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.
31 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.
This study's enrollment of 56 is close to the median of 53 across 29 interventional studies indexed under Dental Pulp Exposure.
Browse Dental Pulp Exposure studies →Hue University of Medicine and Pharmacy is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible teeth received conventional direct pulp capping treatment. After local anesthesia and rubber dam isolation, caries removal and cavity preparation were performed. Hemostasis was achieved using saline-moistened cotton pellets followed by 3% sodium hypochlorite disinfection. Biodentine was placed over the pulp exposure site and the tooth was restored using a selective-etch composite restoration protocol.
Device: Biodentine
Eligible teeth received adjunctive 808-nm diode laser therapy during direct pulp capping. After standard cavity preparation, diode laser irradiation was applied for hemostasis and disinfection before placement of Biodentine and definitive composite restoration. The laser protocol included standardized irradiation parameters for pulp hemostasis and cavity disinfection.
Device: Biodentine · Device: 808-nm Diode Laser
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.
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
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in this study will be shared, including demographic characteristics, postoperative pain scores, dentin hypersensitivity scores, and clinical follow-up outcomes. All personal identifiers will be removed to protect participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6 months following publication and will remain available for 5 years thereafter.
Access criteria: Access will be provided to qualified researchers who submit a methodologically sound proposal for secondary analyses or meta-analysis. Requests should be directed to the corresponding author by email and will be reviewed by the study investigators.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Hue University of Medicine and Pharmacy