Artificial Root-End Barriers

March 7, 2012 updated by: Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio

Clinical Success of Artificial Root-End Barriers With Mineral Trioxide Aggregate in Teeth With Immature Apices

This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices.

Study Overview

Status

Completed

Detailed Description

The normal development and maturation of a root depends on a vital, healthy pulp. If the pulp becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed using an artificial barrier technique. Mineral trioxide aggregate (MTA) has become the material of choice to accomplish this procedure, however, few studies have evaluated its clinical success. The purpose of this retrospective study was to determine the clinical success of ProRoot MTA used as an artificial apical barrier. Twenty patients were included in this study. After approximately one week of Ca(OH)2 treatment, each patient had MTA placed as an apical barrier in a tooth with a single canal and open apex followed by placement of a final restoration. Patients were recalled and evaluated for clinical signs and symptoms and osseous healing. Immediate post-treatment and recall radiographs were evaluated by two endodontists calibrated for use of the Periapical Index (PAI).

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center

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

5 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between 5-40 years old who have been treated with MTA

Description

Inclusion Criteria:

  • a tooth with a single canal and presence of an open apex by radiograph
  • Ca(OH)2 treatment for at least one week prior to obturation
  • use of MTA to produce an artificial apical barrier
  • placement of a final restoration
  • radiographs codumenting pretreatment and immedicate post-treatment conditionof the tooth
  • patients ages 5-40 years old

Exclusion Criteria:

  • patients younger than 5 and greater than 40 years old
  • patients unable to be contacted for recall during the study
  • patients with a medical condition whose health would be jeopardized by participation in the study

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

Cohorts and Interventions

Group / Cohort
Group one
Subjects are drawn from a search of all patients treated with MTA between ages 5-40

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: David Holden, DMD, University of Texas

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

February 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

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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