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Pulpotomy as a Treatment of Irreversible Pulpitis

Primary Purpose

Irreversible Pulpitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulpotomy
Endodontic treatment
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring pulpotomy, pulpitis, mature tooth, tricalcium silicate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Endodontic treatment

    Pulpotomy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    May 30, 2016
    Last Updated
    March 10, 2021
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02920606
    Brief Title
    Pulpotomy as a Treatment of Irreversible Pulpitis
    Official Title
    Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Enrolling by invitation
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irreversible Pulpitis
    Keywords
    pulpotomy, pulpitis, mature tooth, tricalcium silicate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Endodontic treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Pulpotomy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulpotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    Endodontic treatment
    Primary Outcome Measure Information:
    Title
    Evaluation of the success rate (%) at 1 year
    Description
    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
    Time Frame
    Follow up at 1 year for all patients included in the study
    Secondary Outcome Measure Information:
    Title
    Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy
    Description
    During the pulpotomy treatment, blood samples with microcapillaries will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.
    Time Frame
    Follow up at 1 year for all patients included in the study
    Other Pre-specified Outcome Measures:
    Title
    Evaluation of the success rate (%) up to 4 years
    Description
    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
    Time Frame
    Follow up at 4 years for all patients included in the test group

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julian G Leprince, Professor
    Organizational Affiliation
    Cliniques universitaires Saint-Luc
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pulpotomy as a Treatment of Irreversible Pulpitis

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