An interventional study of Direct pulp capping with Biodentine in Reversible Pulpitis and Dental Pulp Exposure, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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.
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.
31 studies on the registry are indexed under Dental Pulp Exposure; 5 are open to participants now.
This study's enrollment of 12 is below the median of 53 across 29 interventional studies indexed under Dental Pulp Exposure.
Browse Dental Pulp Exposure studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: 3 months, and 6 months
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).
Time frame: 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.
Time frame: Baseline, 1 month, 3 months, and 6 months
Plan to share: No — No individual participant data sharing plan has been established at this time.
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Sep 2026, 10 months.
Of 13 interventional studies with no phase under Dental Pulp Exposure, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 15. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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