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Prospective Clinical Trial of Three Apical Sealing Materials

Primary Purpose

Periapical Abscess

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
EndoSequence
ProRoot MTA
Biodentine
Sponsored by
University of the Pacific
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Abscess focused on measuring Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients, American Society of Anesthesiologists (ASA) classification I and II
  • Any tooth with a single chronic periapical lesion requiring apical microsurgery
  • Informed consent signed prior to surgery

Exclusion Criteria:

  • Background of drug/alcohol abuse
  • Adjacent periapical lesion
  • Periodontal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group 1 EndoSequence

    Group 2 ProRoot MTA

    Group 3 Biodentine

    Arm Description

    The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.

    The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.

    The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.

    Outcomes

    Primary Outcome Measures

    Rate of remineralization
    The pace at which new bone is redeposited

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2019
    Last Updated
    December 12, 2019
    Sponsor
    University of the Pacific
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04198298
    Brief Title
    Prospective Clinical Trial of Three Apical Sealing Materials
    Official Title
    Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2, 2014 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of the Pacific

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.
    Detailed Description
    A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periapical Abscess
    Keywords
    Cone-Beam Computed Tomography, Microsurgery, Bone Regeneration, Biocompatible Materials

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 EndoSequence
    Arm Type
    Active Comparator
    Arm Description
    The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
    Arm Title
    Group 2 ProRoot MTA
    Arm Type
    Active Comparator
    Arm Description
    The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
    Arm Title
    Group 3 Biodentine
    Arm Type
    Active Comparator
    Arm Description
    The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
    Intervention Type
    Drug
    Intervention Name(s)
    EndoSequence
    Other Intervention Name(s)
    EndoSequence®
    Intervention Description
    The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
    Intervention Type
    Drug
    Intervention Name(s)
    ProRoot MTA
    Other Intervention Name(s)
    ProRoot® MTA
    Intervention Description
    The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
    Intervention Type
    Drug
    Intervention Name(s)
    Biodentine
    Other Intervention Name(s)
    Biodentine®
    Intervention Description
    The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
    Primary Outcome Measure Information:
    Title
    Rate of remineralization
    Description
    The pace at which new bone is redeposited
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adult patients, American Society of Anesthesiologists (ASA) classification I and II Any tooth with a single chronic periapical lesion requiring apical microsurgery Informed consent signed prior to surgery Exclusion Criteria: Background of drug/alcohol abuse Adjacent periapical lesion Periodontal disease

    12. IPD Sharing Statement

    Learn more about this trial

    Prospective Clinical Trial of Three Apical Sealing Materials

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