Diode Laser-Assisted Direct Pulp Capping Trial

NCT07593508 | Completed

• 1 other identifier: H2022/235
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Pulp Exposure; Postoperative Pain; Dentin Hypersensitivity

Keywords

Direct pulp capping; Biodentine; Diode laser; Postoperative pain; Dentin hypersensitivity; Vital pulp therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical Success Rate

  6 months after treatment

Study Arms (2)

Conventional Biodentine Direct Pulp Capping

ACTIVE COMPARATOR

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

Diode Laser-Assisted Biodentine Direct Pulp Capping

EXPERIMENTAL

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

Interventions

Biodentine DEVICE

Biodentine was used as a bioactive tricalcium silicate pulp-capping material placed directly over the exposed pulp tissue following hemostasis and cavity disinfection.

Conventional Biodentine Direct Pulp Capping; Diode Laser-Assisted Biodentine Direct Pulp Capping

808-nm Diode Laser DEVICE

Adjunctive diode laser irradiation was applied for hemostasis and disinfection before Biodentine placement during direct pulp capping.

Diode Laser-Assisted Biodentine Direct Pulp Capping

Eligibility Criteria

• Age: 10 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (1)

Department of Odonto-Stomatology, Hue University of Medicine and Pharmacy

Huế, 49000, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 32529588 BACKGROUND

• 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.

  PMID: 24756324 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Exposure; Pain, Postoperative; Dentin Sensitivity

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Anh Chi PHAN, PhD

  Hue University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, blinding of participants and care providers was not feasible because diode laser application was visible and audible during treatment. However, the outcome assessor responsible for evaluating postoperative pain, dentin hypersensitivity, and clinical follow-up outcomes was blinded to group allocation throughout the study. All assessment forms were coded by participant ID without treatment information, and participants were instructed not to disclose their treatment assignment during follow-up visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, parallel-group clinical trial in which eligible teeth with carious pulp exposure were allocated in a 1:1 ratio to either conventional direct pulp capping with Biodentine (control group) or diode laser-assisted direct pulp capping with Biodentine (experimental group). Randomization was performed at the tooth level using a computer-generated sequence with allocation concealment by sequentially numbered, opaque, sealed envelopes (SNOSE). Clinical outcomes were evaluated at predefined follow-up intervals by a blinded outcome assessor.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: July 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

VN (1)