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NCT Number: NCT07834424

Direct Pulp Capping With Biodentine in Permanent Teeth With Reversible Pulpitis

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Reversible Pulpitis Dental Pulp Diseases Dental Pulp Exposure Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ho Chi Minh City, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Direct pulp capping with Biodentine

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative pain intensity

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

    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).

  2. Pulp vitality (sensibility response)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

Establishing a Direct Pulp Capping Protocol Using Biodentine in Mature Permanent Teeth With Reversible Pulpitis: A Prospective Case Series

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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