Diode Laser-Assisted Direct Pulp Capping Trial

Effect of Diode Laser Therapy Following Direct Pulp Capping on Postoperative Pain and Dentin Hypersensitivity: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Dentin Hypersensitivity; Dental Pulp Exposure
• Intervention / Treatment: Device: Biodentine; Device: 808-nm Diode Laser

Detailed Description

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
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Huế, Vietnam, 49000
    • Department of Odonto-Stomatology, Hue University of Medicine and Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants aged 10 to 58 years.
• Teeth with pulp exposure caused by caries removal.
• Vital teeth confirmed by clinical pulp vitality tests (cold and heat tests) and radiographic examination.
• No history of spontaneous pain; only mild or tolerable discomfort to cold stimuli.
• Pulp exposure less than 2 mm in diameter.
• Normal radiographic findings with no periapical pathology.
• Bleeding controllable within 10 minutes.
• Written informed consent obtained from participants or legal guardians.

Exclusion Criteria:

• Pulp exposure caused by trauma or occlusal wear.
• Teeth unsuitable for restoration, including subgingival fractures or vertical root cracks.
• Clinical signs of irreversible pulpitis, abscess, or sinus tract.
• Uncontrollable bleeding after 10 minutes of saline pressure or laser hemostasis.
• Previous use of analgesics before treatment.
• Multiple pulp exposures in the same dental arch.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Biodentine Direct Pulp Capping; 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; Biodentine was used as a bioactive tricalcium silicate pulp-capping material placed directly over the exposed pulp tissue following hemostasis and cavity disinfection.
Experimental: Diode Laser-Assisted Biodentine Direct Pulp Capping; 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; Biodentine was used as a bioactive tricalcium silicate pulp-capping material placed directly over the exposed pulp tissue following hemostasis and cavity disinfection.; Device: 808-nm Diode Laser; Adjunctive diode laser irradiation was applied for hemostasis and disinfection before Biodentine placement during direct pulp capping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Daily until complete pain resolution (up to 7 days after treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after treatment

Collaborators and Investigators

• Sponsor: Hue University of Medicine and Pharmacy
• Investigators: Principal Investigator: Anh Chi PHAN, PhD, Hue University of Medicine and Pharmacy

Publications and helpful links

General Publications

• Yazdanfar I, Barekatain M, Zare Jahromi M. Combination effects of diode laser and resin-modified tricalcium silicate on direct pulp capping treatment of caries exposures in permanent teeth: a randomized clinical trial. Lasers Med Sci. 2020 Oct;35(8):1849-1855. doi: 10.1007/s10103-020-03052-9. Epub 2020 Jun 11.
• Yazdanfar I, Gutknecht N, Franzen R. Effects of diode laser on direct pulp capping treatment : a pilot study. Lasers Med Sci. 2015 May;30(4):1237-43. doi: 10.1007/s10103-014-1574-8. Epub 2014 Apr 23.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative pain; Diode laser; Biodentine; Vital pulp therapy; Dentin hypersensitivity; Direct pulp capping
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Dental Pulp Diseases; Tooth Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Dentin Sensitivity; Dental Pulp Exposure; Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: H2022/235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available beginning 6 months following publication and will remain available for 5 years thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No