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

NCT07112859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-08

No results posted yet for this study

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.

Conditions

  • Symptomatic Irreversible Pulpitis

Interventions

PROCEDURE

Complete 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 & Collaborators

  • HITEC-Institute of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-02
Primary Completion
2025-07-02
Completion
2025-07-02

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07112859 on ClinicalTrials.gov