Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Controlled Trial of Fiber Post Restorations

This study has been completed.
Information provided by (Responsible Party):
Prof. Marco Ferrari, University of Siena Identifier:
First received: February 5, 2012
Last updated: February 10, 2012
Last verified: February 2012

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.

Condition Intervention
Restoration Survival
Procedure: post placement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Survival of Endodontically Treated and Restored Premolars: A Randomized Controlled Trial

Further study details as provided by University of Siena:

Primary Outcome Measures:
  • survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: January 2003
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: post restoration Procedure: post placement
placement of an endocanalar post
Other Names:
  • Prefabricated post DT LightPost, RTD
  • Customized post, EverStick Post, StickTech
No Intervention: no post restoration
no post placement


Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Marco Ferrari, Professor, University of Siena Identifier: NCT01532947     History of Changes
Other Study ID Numbers: RCTFP1
Study First Received: February 5, 2012
Last Updated: February 10, 2012
Health Authority: Italy: Ethics Committee processed this record on March 02, 2015