Pulpotomy as a Treatment of Irreversible Pulpitis

Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: Endodontic treatment; Procedure: Pulpotomy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Endodontic treatment
Experimental: 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.	Procedure: Pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the success rate (%) at 1 year	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	Follow up at 1 year for all patients included in the study

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the success rate (%) up to 4 years	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	Follow up at 4 years for all patients included in the test group

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Study Chair: Julian G Leprince, Professor, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: pulpotomy; pulpitis; mature tooth; tricalcium silicate
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: Pulpotomie-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No