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Prospective Clinical Trial of Three Apical Sealing Materials

Sponsor
University of the Pacific (Other)
Overall Status
Completed
CT.gov ID
NCT04198298
Collaborator
(none)
59
Enrollment
3
Arms
30.9
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
59 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials
Actual Study Start Date :
Nov 2, 2014
Actual Primary Completion Date :
May 31, 2017
Actual Study Completion Date :
May 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1 EndoSequence

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

Drug: EndoSequence
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
Other Names:
  • EndoSequence®

    		•
    Active Comparator: Group 2 ProRoot MTA

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

    Drug: ProRoot MTA
    The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
    Other Names:
  • ProRoot® MTA

    		•
    Active Comparator: Group 3 Biodentine

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

    Drug: Biodentine
    The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
    Other Names:
  • Biodentine®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of remineralization [6 months]

      The pace at which new bone is redeposited

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of the Pacific

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of the Pacific
    ClinicalTrials.gov Identifier:
    NCT04198298
    Other Study ID Numbers:
    • 20-60
    First Posted:
    Dec 13, 2019
    Last Update Posted:
    Dec 13, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of the Pacific
    Cone-Beam Computed Tomography
    Microsurgery
    Bone Regeneration
    Biocompatible Materials
    Additional relevant MeSH terms:
    Periapical Abscess

    Study Results

    No Results Posted as of Dec 13, 2019