search
Back to results

Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer

Primary Purpose

Apical Periodontitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Root Canal Treatment
Sponsored by
Cittadella Universitaria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring root canal obturation, hydraulic sealer, single cone, endodontic outcome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a permanent, single or multi-rooted mature tooth
  • clinical diagnosis of irreversible pulpitis
  • diagnosis of apical periodontitis

Exclusion Criteria:

  • subjects with immune-compromised status
  • subjects with an overall poor prognosis for their treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hydraulic Sealer Group

    Zinc oxide-eugenol Sealer Group

    Arm Description

    The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer. Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity.

    The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation.

    Outcomes

    Primary Outcome Measures

    Periapical Healing
    Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2)

    Secondary Outcome Measures

    tooth survival
    Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score

    Full Information

    First Posted
    January 28, 2020
    Last Updated
    January 29, 2020
    Sponsor
    Cittadella Universitaria
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04249206
    Brief Title
    Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cittadella Universitaria

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apical Periodontitis
    Keywords
    root canal obturation, hydraulic sealer, single cone, endodontic outcome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydraulic Sealer Group
    Arm Type
    Experimental
    Arm Description
    The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer. Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity.
    Arm Title
    Zinc oxide-eugenol Sealer Group
    Arm Type
    Active Comparator
    Arm Description
    The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Root Canal Treatment
    Primary Outcome Measure Information:
    Title
    Periapical Healing
    Description
    Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score <2)
    Time Frame
    4 year
    Secondary Outcome Measure Information:
    Title
    tooth survival
    Description
    Success was defined if the tooth was asymptomatic and considered to be functional regardless of its PAI score
    Time Frame
    4 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a permanent, single or multi-rooted mature tooth clinical diagnosis of irreversible pulpitis diagnosis of apical periodontitis Exclusion Criteria: subjects with immune-compromised status subjects with an overall poor prognosis for their treatment

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32989597
    Citation
    Bardini G, Casula L, Ambu E, Musu D, Mercade M, Cotti E. A 12-month follow-up of primary and secondary root canal treatment in teeth obturated with a hydraulic sealer. Clin Oral Investig. 2021 May;25(5):2757-2764. doi: 10.1007/s00784-020-03590-0. Epub 2020 Sep 28. Erratum In: Clin Oral Investig. 2021 Aug;25(8):5121.
    Results Reference
    derived

    Learn more about this trial

    Outcome of Endodontic Treatment in Patient Treated With a Hydraulic Sealer

    We'll reach out to this number within 24 hrs