Randomized Controlled Trial of Fiber Post Restorations

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Prof. Marco Ferrari, University of Siena

ClinicalTrials.gov Identifier:

NCT01532947

First received: February 5, 2012

Last updated: February 10, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 5, 2012
Last Updated Date	February 10, 2012
Start Date ^ICMJE	January 2003
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2012)	survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01532947 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Controlled Trial of Fiber Post Restorations
Official Title ^ICMJE	Survival of Endodontically Treated and Restored Premolars: A Randomized Controlled Trial
Brief Summary	This in vivo study examined the contribution of remaining coronal dentin and placement of a prefabricated or customized fiber post to the six-year survival of endodontically treated premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic treatment. Groups were classified according to the number of remaining coronal walls before abutment build-up. Within each group, teeth were allocated to three subgroups: A) no post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression analysis was applied to assess whether the amount of residual coronal dentin and the type of endocanalar retention had a significant influence on failure risk of the restored teeth.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Restoration Survival
Intervention ^ICMJE	Procedure: post placement placement of an endocanalar post Other Names: Prefabricated post DT LightPost, RTD Customized post, EverStick Post, StickTech
Study Arm (s)	Experimental: post restoration Intervention: Procedure: post placement No Intervention: no post restoration no post placement
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 ^ICMJE	Completed
Enrollment ^ICMJE	360
Completion Date	Not Provided
Primary Completion Date	June 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: endodontically treated premolars with symptom-free root canal filling and a minimum apical seal of 4 mm, in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth. Exclusion Criteria: periapical lesion on the X-ray.
Gender	Both
Ages	18 Years to 76 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01532947
Other Study ID Numbers ^ICMJE	RCTFP1
Has Data Monitoring Committee	No
Responsible Party	Prof. Marco Ferrari, University of Siena
Study Sponsor ^ICMJE	University of Siena
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Siena
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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