NCT07834424

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 11, 2026

Last Update Submit

September 22, 2026

Conditions

Reversible PulpitisDental Pulp Exposure

Keywords

Direct pulp cappingBiodentineVital pulp therapyCalcium silicate cement

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months, and 6 months

Secondary Outcomes (2)

  • Postoperative pain intensity

    24 hours, day 2-7, week 2-4, 3 months, and 6 months

  • Pulp vitality (sensibility response)

    Baseline, 1 month, 3 months, and 6 months

Study Arms (1)

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.

Procedure: Direct pulp capping with Biodentine

Interventions

Direct pulp capping with BiodentinePROCEDURE

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.

Direct pulp capping with Biodentine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

tricalcium silicate

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Bao Chau T Vu, DDS, PhD

    University of Medicine and Pharmacy at Ho Chi Minh City

    STUDY DIRECTOR

  • Huynh Anh Bui, DDS, PhD

    University of Medicine and Pharmacy at Ho Chi Minh City

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm case series; all participants received direct pulp capping with Biodentine.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 22, 2026

Study Start

November 5, 2025

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

No individual participant data sharing plan has been established at this time.

Locations

VN(1)