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Trial record 2 of 150 for:    tooth anomalies

Artificial Root-End Barriers

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ClinicalTrials.gov Identifier: NCT00595842
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : March 8, 2012
Sponsor:
Collaborator:
Wilford Hall Medical Center
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date January 7, 2008
First Posted Date January 16, 2008
Last Update Posted Date March 8, 2012
Study Start Date February 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00595842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Artificial Root-End Barriers
Official Title Clinical Success of Artificial Root-End Barriers With Mineral Trioxide Aggregate in Teeth With Immature Apices
Brief Summary This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices.
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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients between 5-40 years old who have been treated with MTA
Condition
  • Dental Cements
  • Tooth Abnormalities
Intervention Not Provided
Study Groups/Cohorts Group one
Subjects are drawn from a search of all patients treated with MTA between ages 5-40
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 18, 2008)
10
Original Estimated Enrollment
 (submitted: January 15, 2008)
75
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00595842
Other Study ID Numbers HSC20070204
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
Study Sponsor The University of Texas Health Science Center at San Antonio
Collaborators Wilford Hall Medical Center
Investigators
Principal Investigator: David Holden, DMD University of Texas
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date March 2012