Artificial Root-End Barriers

This study has been completed.
Sponsor:
Collaborator:
Wilford Hall Medical Center
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00595842
First received: January 7, 2008
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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


Condition
Dental Cements
Tooth Abnormalities

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Success of Artificial Root-End Barriers With Mineral Trioxide Aggregate in Teeth With Immature Apices

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Enrollment: 10
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group one
Subjects are drawn from a search of all patients treated with MTA between ages 5-40

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).

  Eligibility

Ages Eligible for Study:   5 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595842

Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Wilford Hall Medical Center
Investigators
Principal Investigator: David Holden, DMD University of Texas
  More Information

No publications provided

Responsible Party: Kenneth Hargreaves, Chair, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00595842     History of Changes
Other Study ID Numbers: HSC20070204
Study First Received: January 7, 2008
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Mineral trioxide aggregate

Additional relevant MeSH terms:
Congenital Abnormalities
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 29, 2014