- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00595842
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
Conditions
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
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Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center
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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 |
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Group one
Subjects are drawn from a search of all patients treated with MTA between ages 5-40
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20070204
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.