Dental Pulp ExposureNCT07593508
Diode Laser-Assisted Direct Pulp Capping Trial
A study testing Biodentine and 808-nm Diode Laser in people with Dental Pulp Exposure and Postoperative Pain, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 58 years
- Conditions the study is for
- Dental Pulp Exposure, Postoperative Pain, Dentin Hypersensitivity
- What is being tested?
- Biodentine and 808-nm Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 58 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Department of Odonto-Stomatology, Hue University of Medicine and Pharmacy
Huế, 49000
About this study
Official title: 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.
Read the 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.
- Being tested
- Biodentine, 808-nm Diode Laser
- Keywords
- Direct pulp capping, Biodentine, Diode laser, Postoperative pain, Dentin hypersensitivity, Vital pulp therapy
- Medical subject headings
- Dental Pulp Exposure, Pain, Postoperative, Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDevice
Biodentine was used as a bioactive tricalcium silicate pulp-capping material placed directly over the exposed pulp tissue following hemostasis and cavity disinfection.
808-nm Diode LaserDevice
Adjunctive diode laser irradiation was applied for hemostasis and disinfection before Biodentine placement during direct pulp capping.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Biodentine; Device: 808-nm Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Daily until complete pain resolution (up to 7 days after treatment)
Secondary outcomes (1)
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.
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jul 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anh Chi PHAN, PhD, Principal investigator, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593508
- Sponsor's protocol ID
- H2022/235
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 32529588Yazdanfar 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.
PubMed 24756324
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diode Laser Therapy Following Direct Pulp Capping on Postoperative Pain and Dentin Hypersensitivity: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07593508
- Acronym / sponsor ID
- H2022/235
- Keywords
- Direct pulp capping, Biodentine, Diode laser, Postoperative pain, Dentin hypersensitivity, Vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Biodentine Direct Pulp Capping | Active comparator | Device: BiodentineEligible 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. |
| Diode Laser-Assisted Biodentine Direct Pulp Capping | Experimental | Device: Biodentine, Device: 808-nm Diode LaserEligible 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. |
Who may qualify
- Ages
- 10 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiodentineBiodentine was used as a bioactive tricalcium silicate pulp-capping material placed directly over the exposed pulp tissue following hemostasis and cavity disinfection. | Device | Conventional Biodentine Direct Pulp Capping, Diode Laser-Assisted Biodentine Direct Pulp Capping |
| 808-nm Diode LaserAdjunctive diode laser irradiation was applied for hemostasis and disinfection before Biodentine placement during direct pulp capping. | Device | Diode Laser-Assisted Biodentine Direct Pulp Capping |
Primary outcome
Dentin Hypersensitivity
Time frame: 1 month, 3 months, and 6 months after treatment
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.
Postoperative Pain Intensity
Time frame: Daily until complete pain resolution (up to 7 days after treatment)
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.
1 secondary outcome
Clinical Success Rate
Time frame: 6 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 32529588Yazdanfar 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.
- Background: PubMed 24756324Yazdanfar 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anh Chi PHAN, PhD principal investigator
Hue University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine and 808-nm Diode Laser in people with Dental Pulp Exposure and Postoperative Pain, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentin Hypersensitivity (time frame: 1 month, 3 months, and 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.