Pulpotomy as a Treatment of Irreversible Pulpitis

NCT ID: NCT02920606

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2024-06-30

Brief Summary

The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endodontic treatment

The patient will benefit from a conventional treatment : a root canal treatment.

The root canal treatment consists of removing the pulp tissue from all the canals, disinfecting the root canal system with sodium hypochlorite and filling the root with a root canal sealer and gutta percha.

Group Type: ACTIVE_COMPARATOR

Endodontic treatment

Intervention Type: PROCEDURE

Pulpotomy

The patient will benefit from an experimental treatment : a pulpotomy. The pulpotomy aims at removing the coronal part of the pulp (the pulp present in the pulp chamber) and filling the pulp chamber with a bioactive material.

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: PROCEDURE

Interventions

Pulpotomy

Intervention Type: PROCEDURE

Endodontic treatment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Good general health
• Not pregnant women
• At least one permanent molar in irreversible pulpitis
• Adult patient
• Mentally competent

Exclusion Criteria

• Periapical radiolucency
• Periodontical probing
• Root fracture
• Sinus tract
• Swelling or mobility
• External or/and internal resorption
• Open apicies
• A non restorable tooth

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian G Leprince, Professor

Role: STUDY_CHAIR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other Identifiers

Pulpotomie-1

Identifier Type: -

Identifier Source: org_study_id