Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Federal University of Pelotas
Sponsor:
Collaborator:
Universidade Federal de Santa Maria
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT01461239
First received: July 5, 2011
Last updated: July 19, 2013
Last verified: July 2013

July 5, 2011
July 19, 2013
July 2009
December 2013   (final data collection date for primary outcome measure)
Post and core survival [ Time Frame: 72 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01461239 on ClinicalTrials.gov Archive Site
  • patient satisfaction with the treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • quality of crowns and restorations (FDI criteria) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • endodontic success [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    assessed by periapical radiographs for observation of apical lesion presence or absence
Same as current
Not Provided
Not Provided
 
Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts

There are few randomized controlled trials comparing intraradicular posts used to restore endodontically treated teeth, especially considering cast posts and glass fiber posts. The investigators study will evaluate the clinical success rates of endodontically treated teeth restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included in this study should present any tooth with endodontic treatment and need of intraradicular retention (post) on maxilla or mandible according to inclusion and exclusion criteria. Individuals will be randomly allocated into two groups: (1) endodontically treated teeth restored with fiber post and composite resin core and metal ceramic crown or (2) endodontically treated teeth restored with cast post and core and metal ceramic crown. A sample size calculation will be performed to establish the number of posts needed for comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals will be examined by calibrated examiners, in years 1 to 3. The reason of failure will be categorized as root fracture, fracture of the post, post debonding, clinical and/or radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post and Core Failure
  • Procedure: fiber post and resin core - self-adhesive cement
    pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement
  • Procedure: cast post and core
    Ni-Cr alloy cast post and core luted with self-adhesive resin cement
  • Procedure: fiber post luted with conventional resin cement
    fiber post luted with conventional etch-and-rinse adhesive system and conventional resin cement, followed by core construction with composite resin
  • Active Comparator: cast post and core
    Intervention: Procedure: cast post and core
  • Experimental: fiber post - self-adhesive cement
    Intervention: Procedure: fiber post and resin core - self-adhesive cement
  • Experimental: fiber post - conventional cement
    Intervention: Procedure: fiber post luted with conventional resin cement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients with normal occlusion with at least one teeth endodontically treated needing restoration

Exclusion Criteria:

  • patients with malocclusion,
  • orthodontic devices,
  • temporomandibular disorders
Both
18 Years to 70 Years
Yes
Contact: Tatiana Pereira-Cenci, PhD +55 53 32226690 tatiana.dds@gmail.com
Contact: Maximiliano S Cenci, PhD 5332226690 ext 134 cencims@gmail.com
Brazil
 
NCT01461239
UFPEL-PPGO0010
No
Maximiliano Sergio Cenci, Federal University of Pelotas
Federal University of Pelotas
Universidade Federal de Santa Maria
Principal Investigator: Tatiana Pereira-Cenci, PhD Federal University of Pelotas
Principal Investigator: Rogério Castilho Jacinto, PhD Federal University of Pelotas
Federal University of Pelotas
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP