Prospective Clinical Trial of Three Apical Sealing Materials

December 12, 2019 updated by: University of the Pacific

Prospective Comparative Randomized Clinical Trial of Three Endodontic Retrograde Filling Materials

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 EndoSequence
The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
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.
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.
The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
Other Names:
  • Biodentine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of remineralization
Time Frame: 6 months
The pace at which new bone is redeposited
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2014

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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