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

NCT07112859 | Completed DMC

• 1 other identifier: Dr Farhana altaf
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Success of Complete Pulpotom

  Clinical 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.

  Evaluated at 7 days, 1 month, and 3 months post-procedure

Study Arms (1)

Complete Pulpotomy with Biodentine

EXPERIMENTAL

Patients with mature permanent single-rooted teeth diagnosed with symptomatic irreversible pulpitis will undergo complete pulpotomy. The coronal pulp will be removed, and Biodentine will be placed on the remaining radicular pulp, followed by restoration. Patients will be followed up to evaluate treatment success.

Procedure: Complete Pulpotomy with Biodentine

Interventions

Complete Pulpotomy with Biodentine PROCEDURE

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.

Complete Pulpotomy with Biodentine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (1)

• Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.

  PMID: 35226769 BACKGROUND

MeSH Terms

Interventions

tricalcium silicate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Farhana

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: July 2, 2024
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)