Pulpotomy as a Treatment of Irreversible Pulpitis

Not Applicable

• Conditions: Irreversible Pulpitis
• Interventions: Procedure: Pulpotomy; Procedure: Endodontic treatment

• Registration Number: NCT02920606
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11
• Primary Completion: 2021-10
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulpotomy	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.
Endodontic treatment	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of the success rate (%) at 1 year	Follow up at 1 year for all patients included in the study	to evaluate the treatment success defined as the absence of clinical symptoms (pain, sinus tract..) and the absence of radiological symptoms (periapical radiolucency), in order to point the non-inferiority of the pulpotomy compared with the conventional treatment

Secondary Outcome Measures

Name	Time	Method
Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy	Follow up at 1 year for all patients included in the study	During the pulpotomy treatment, blood samples with microcapillaries will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.