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

NCT ID: NCT07112859

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2025-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Complete Pulpotomy with Biodentine

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.

Group Type EXPERIMENTAL

Complete Pulpotomy with Biodentine

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr Farhana Altaf

Dr Farhana

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 35226769 (View on PubMed)

Other Identifiers

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Dr Farhana altaf

Identifier Type: -

Identifier Source: org_study_id

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