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
  Purpose

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%.


Condition Intervention Phase
Post and Core Failure
Procedure: fiber post and resin core - self-adhesive cement
Procedure: cast post and core
Procedure: fiber post luted with conventional resin cement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts

Resource links provided by NLM:


Further study details as provided by Federal University of Pelotas:

Primary Outcome Measures:
  • Post and core survival [ Time Frame: 72 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cast post and core Procedure: cast post and core
Ni-Cr alloy cast post and core luted with self-adhesive resin cement
Experimental: fiber post - self-adhesive cement Procedure: fiber post and resin core - self-adhesive cement
pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement
Experimental: fiber post - conventional 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461239

Contacts
Contact: Tatiana Pereira-Cenci, PhD +55 53 32226690 tatiana.dds@gmail.com
Contact: Maximiliano S Cenci, PhD 5332226690 ext 134 cencims@gmail.com

Locations
Brazil
School of Dentistry - Federal University of Pelotas Recruiting
Pelotas, RS, Brazil, 96015560
Contact: Maximiliano S Cenci, PhD    +55 53 32226690 ext 134    cencims@gmail.com   
Sponsors and Collaborators
Federal University of Pelotas
Universidade Federal de Santa Maria
Investigators
Principal Investigator: Tatiana Pereira-Cenci, PhD Federal University of Pelotas
Principal Investigator: Rogério Castilho Jacinto, PhD Federal University of Pelotas
  More Information

No publications provided

Responsible Party: Maximiliano Sergio Cenci, PhD, Coordinator of Clinical Trials, Graduate Program in Dentistry, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT01461239     History of Changes
Other Study ID Numbers: UFPEL-PPGO0010
Study First Received: July 5, 2011
Last Updated: July 19, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Pelotas:
survival
debonding
endodontic treated teeth

Additional relevant MeSH terms:
Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014