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Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis

Evaluation of Success of Complete Pulpotomy With Biodentine on Mature Permanent Single Rooted Teeth With Symptomatic Irreversible Pulpitis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07112859
Enrollment
40
Registered
2025-08-08
Start date
2024-07-02
Completion date
2025-07-02
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Irreversible Pulpitis

Brief summary

This study aims to evaluate the clinical success of complete pulpotomy using Biodentine in mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis. Complete pulpotomy involves removal of the coronal pulp and preservation of radicular pulp vitality using a biocompatible pulp-capping material. Biodentine, a calcium silicate-based cement, has favorable biological properties, including biocompatibility, antibacterial effects, and dentin bridge formation potential. A total of 84 patients meeting the inclusion criteria will be enrolled and treated by a single operator. Clinical success will be evaluated at 7 days, 1 month, and 3 months based on absence of pain, swelling, tenderness to percussion, and radiographic signs of periapical pathology.

Interventions

PROCEDUREComplete Pulpotomy with Biodentine

Administration of local anesthesia followed by rubber dam isolation. Removal of coronal pulp tissue to perform a complete pulpotomy. Hemostasis achieved with saline-soaked cotton pellet. Placement of Biodentine as the pulp-capping agent on the radicular pulp. Temporary restoration placed immediately after Biodentine placement. Permanent composite restoration placed after 1 week. Follow-up visits at 7 days, 1 month, and 3 months for clinical and radiographic evaluation.

Sponsors

HITEC-Institute of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Mature permanent single rooted teeth with: * Symptomatic irreversible pulpitis * Age group 20-50 years

Exclusion criteria

* • Uncontrolled pulp heamorrhage (more than 5mins) * Necrotic pulp * Periapical periodontitis * Sinus tract * Abnormal tooth mobility * Single rooted teeth with internal or external root resorption * Calcified root canals

Design outcomes

Primary

MeasureTime frameDescription
Success of Complete PulpotomEvaluated at 7 days, 1 month, and 3 months post-procedureClinical assessment of pain, swelling, and tenderness on percussion. Radiographic evaluation for absence of periapical lesions and root resorption. Success defined as absence of symptoms and radiographic signs of pathology, indicating maintenance of pulp vitality.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026