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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595842
Other study ID # HSC20070204
Secondary ID
Status Completed
Phase N/A
First received January 7, 2008
Last updated March 7, 2012
Start date February 2007
Est. completion date June 2008

Study information

Verified date March 2012
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 40 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Texas Health Science Center San Antonio Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio Wilford Hall Medical Center

Country where clinical trial is conducted

United States, 

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