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

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ClinicalTrials.gov Identifier: NCT01461239
Recruitment Status : Unknown
Verified April 2017 by Maximiliano Sergio Cenci, Federal University of Pelotas.
Recruitment status was:  Recruiting
First Posted : October 28, 2011
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Universidade Federal de Santa Maria
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Tracking Information
First Submitted Date  ICMJE July 5, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date April 6, 2017
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
Post and core survival [ Time Frame: 72 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • patient satisfaction with the treatment [ Time Frame: 18 months ]
  • quality of crowns and restorations (FDI criteria) [ Time Frame: 18 months ]
  • endodontic success [ Time Frame: 18 months ]
    assessed by periapical radiographs for observation of apical lesion presence or absence
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
Official Title  ICMJE Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
Brief Summary 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%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post and Core Failure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461239
Other Study ID Numbers  ICMJE UFPEL-PPGO0010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maximiliano Sergio Cenci, Federal University of Pelotas
Study Sponsor  ICMJE Federal University of Pelotas
Collaborators  ICMJE Universidade Federal de Santa Maria
Investigators  ICMJE
Principal Investigator: Tatiana Pereira-Cenci, PhD Federal University of Pelotas
Principal Investigator: Rogério Castilho Jacinto, PhD Federal University of Pelotas
PRS Account Federal University of Pelotas
Verification Date April 2017

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