Reversible PulpitisNCT07834424
Direct Pulp Capping With Biodentine in Permanent Teeth With Reversible Pulpitis
A study testing Direct pulp capping with Biodentine in people with Reversible Pulpitis and Dental Pulp Exposure, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This study evaluates the clinical and radiographic outcomes of direct pulp capping using Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, in mature permanent teeth diagnosed with reversible pulpitis following carious or mechanical pulp exposure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reversible Pulpitis, Dental Pulp Exposure
- What is being tested?
- Direct pulp capping with Biodentine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Nov 2025to 30 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mature permanent teeth clinically diagnosed with reversible pulpitis
- Vital pulp exposure (carious or mechanical) confirmed intra-operatively
- Positive response to pulp sensibility testing (cold and/or electric pulp test) at baseline
- Successful haemostasis of the exposed pulp achieved within 6 minutes
- Patient consent to follow-up
Who cannot join
- Irreversible pulpitis or pulp necrosis
- Spontaneous or lingering pain
- Radiographic periapical pathology
- Haemostasis not achieved within the time limit
- Non-restorable teeth
- Teeth with periodontal compromise
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 70000
About this study
Official title: Establishing a Direct Pulp Capping Protocol Using Biodentine in Mature Permanent Teeth With Reversible Pulpitis: A Prospective Case Series
This study evaluates the clinical and radiographic outcomes of direct pulp capping using Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, in mature permanent teeth diagnosed with reversible pulpitis following carious or mechanical pulp exposure. Biodentine was placed as a full-thickness (bulk) capping and interim restoration, with a definitive composite restoration completed at a later visit. Pulp vitality, postoperative pain, and radiographic healing are assessed over a 6-month follow-up period.
Read the detailed description
Mature permanent teeth clinically diagnosed with reversible pulpitis and presenting vital pulp exposure (carious or mechanical) were treated with direct pulp capping. After caries removal under rubber dam isolation, haemostasis of the exposed pulp was achieved with 2.5% sodium hypochlorite. Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, was then placed as a full-thickness (bulk) direct pulp capping material, filling the cavity and serving as an interim restoration. At a subsequent visit (approximately 2 to 6 weeks later), the superficial layer of Biodentine was reduced and a definitive composite restoration was placed. Participants were followed clinically and radiographically at 1 week, 1 month, 3 months, and 6 months to assess pulp vitality, symptoms, and periapical status, including dentin bridge formation.
- Conditions
- Reversible Pulpitis, Dental Pulp Exposure
- Being tested
- Direct pulp capping with Biodentine
- Keywords
- Direct pulp capping, Biodentine, Vital pulp therapy, Calcium silicate cement
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp capping with BiodentineProcedure or surgery
After caries removal under rubber dam isolation, haemostasis of the exposed vital pulp was achieved with 2.5% sodium hypochlorite. Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, was mixed and placed directly over the pulp exposure as a full-thickness (bulk) capping and interim restoration. At a subsequent visit (approximately 2 to 6 weeks later), the superficial Biodentine layer was reduced and a definitive composite restoration was placed.
| Study group | Role | What they receive |
|---|---|---|
| Direct pulp capping with Biodentine | Experimental | All participants received direct pulp capping with Biodentine placed as a full-thickness (bulk) capping and interim restoration, followed by a definitive composite restoration at a subsequent visit. Receives: Procedure: Direct pulp capping with Biodentine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall treatment success
Number of teeth with overall treatment success, defined as meeting both clinical and radiographic success criteria simultaneously. Clinical success: no spontaneous or lingering pain, negative percussion test, normal peri-radicular soft tissue (no swelling or sinus tract), positive response to pulp sensibility testing (transient cold response and electric pulp test within normal limits), and no abnormal tooth discoloration. Radiographic success: normal peri-radicular structures with continuous lamina dura and non-widened periodontal ligament space, no new periapical radiolucency, no internal or external root resorption, and stable pulp chamber and canal morphology. Reported as the number of teeth meeting the success criteria.
Measured: 3 months, and 6 months
Secondary outcomes (2)
Postoperative pain intensity
Postoperative pain intensity measured using the Visual Analogue Scale (VAS), a 0 to 10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain (higher scores indicate a worse outcome).
Measured: 24 hours, day 2-7, week 2-4, 3 months, and 6 months
Pulp vitality (sensibility response)
Number of teeth retaining pulp vitality, defined as a positive response to pulp sensibility testing (cold test and/or electric pulp test). Reported as the number of teeth with a positive sensibility response.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start5 Nov 2025
- Primary completion25 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm case series; all participants received direct pulp capping with Biodentine.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Thi My Linh, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Bao Chau T Vu, DDS, PhD, Study director, University of Medicine and Pharmacy at Ho Chi Minh CityHuynh Anh Bui, DDS, PhD, Study director, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834424
- Sponsor's protocol ID
- 25343-DHYD
- Other IDs
- 25343-DHYD, 3776/DHYD-HDDD
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing plan has been established at this time.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Direct Pulp Capping Protocol Using Biodentine in Mature Permanent Teeth With Reversible Pulpitis: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT07834424
- Acronym / sponsor ID
- 25343-DHYD
- Conditions
- Reversible Pulpitis, Dental Pulp Exposure
- Keywords
- Direct pulp capping, Biodentine, Vital pulp therapy, Calcium silicate cement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 22 Sep 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 study evaluates the clinical and radiographic outcomes of direct pulp capping using Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, in mature permanent teeth diagnosed with reversible pulpitis following carious or mechanical pulp exposure. Biodentine was placed as a full-thickness (bulk) capping and interim restoration, with a definitive composite restoration completed at a later visit. Pulp vitality, postoperative pain, and radiographic healing are assessed over a 6-month follow-up period.
Detailed description
Mature permanent teeth clinically diagnosed with reversible pulpitis and presenting vital pulp exposure (carious or mechanical) were treated with direct pulp capping. After caries removal under rubber dam isolation, haemostasis of the exposed pulp was achieved with 2.5% sodium hypochlorite. Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, was then placed as a full-thickness (bulk) direct pulp capping material, filling the cavity and serving as an interim restoration. At a subsequent visit (approximately 2 to 6 weeks later), the superficial layer of Biodentine was reduced and a definitive composite restoration was placed. Participants were followed clinically and radiographically at 1 week, 1 month, 3 months, and 6 months to assess pulp vitality, symptoms, and periapical status, including dentin bridge formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm case series; all participants received direct pulp capping with Biodentine.
| Arm | Type | Receives |
|---|---|---|
| Direct pulp capping with Biodentine | Experimental | Procedure: Direct pulp capping with BiodentineAll participants received direct pulp capping with Biodentine placed as a full-thickness (bulk) capping and interim restoration, followed by a definitive composite restoration at a subsequent visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mature permanent teeth clinically diagnosed with reversible pulpitis
- Vital pulp exposure (carious or mechanical) confirmed intra-operatively
- Positive response to pulp sensibility testing (cold and/or electric pulp test) at baseline
- Successful haemostasis of the exposed pulp achieved within 6 minutes
- Patient consent to follow-up
Key exclusion criteria (6 listed)
- Irreversible pulpitis or pulp necrosis
- Spontaneous or lingering pain
- Radiographic periapical pathology
- Haemostasis not achieved within the time limit
- Non-restorable teeth
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 |
|---|---|---|
| Direct pulp capping with BiodentineAfter caries removal under rubber dam isolation, haemostasis of the exposed vital pulp was achieved with 2.5% sodium hypochlorite. Biodentine (Septodont, Saint-Maur-des-Fossés, France), a calcium silicate-based cement, was mixed and placed directly over the pulp exposure as a full-thickness (bulk) capping and interim restoration. At a subsequent visit (approximately 2 to 6 weeks later), the superficial Biodentine layer was reduced and a definitive composite restoration was placed. | Procedure or surgery | Direct pulp capping with Biodentine |
Primary outcome
Overall treatment success
Time frame: 3 months, and 6 months
Number of teeth with overall treatment success, defined as meeting both clinical and radiographic success criteria simultaneously. Clinical success: no spontaneous or lingering pain, negative percussion test, normal peri-radicular soft tissue (no swelling or sinus tract), positive response to pulp sensibility testing (transient cold response and electric pulp test within normal limits), and no abnormal tooth discoloration. Radiographic success: normal peri-radicular structures with continuous lamina dura and non-widened periodontal ligament space, no new periapical radiolucency, no internal or external root resorption, and stable pulp chamber and canal morphology. Reported as the number of teeth meeting the success criteria.
2 secondary outcomes
Postoperative pain intensity
Time frame: 24 hours, day 2-7, week 2-4, 3 months, and 6 months
Pulp vitality (sensibility response)
Time frame: Baseline, 1 month, 3 months, and 6 months
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 14 Oct 2026.
- Individual participant dataSharing planned: No. No individual participant data sharing plan has been established at this time.
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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.
Bao Chau T Vu, DDS, PhD study director
University of Medicine and Pharmacy at Ho Chi Minh City
Huynh Anh Bui, DDS, PhD study director
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct pulp capping with Biodentine in people with Reversible Pulpitis and Dental Pulp Exposure, run by University of Medicine and Pharmacy at Ho Chi Minh City 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 5 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 14 Oct 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?
Overall treatment success (time frame: 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.