NCT02920606

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

5.5 years

First QC Date

May 30, 2016

Last Update Submit

March 10, 2021

Conditions

Irreversible Pulpitis

Keywords

pulpotomypulpitismature toothtricalcium silicate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Other Outcomes (1)

  • Evaluation of the success rate (%) up to 4 years

    Follow up at 4 years for all patients included in the test group

Study Arms (2)

Endodontic treatment

ACTIVE COMPARATOR

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

Pulpotomy

EXPERIMENTAL

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

Interventions

PulpotomyPROCEDURE
Pulpotomy
Endodontic treatmentPROCEDURE
Endodontic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulpitis

Interventions

PulpotomyEndodontics

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Julian G Leprince, Professor

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

September 30, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2021

Study Completion

June 1, 2024

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share