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

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

Tracking Information

• First Submitted Date: July 5, 2011
• First Posted Date: October 28, 2011
• Last Update Posted Date: April 6, 2017
• Study Start Date: July 2009
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 26, 2011): Post and core survival [ Time Frame: 72 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Post and Core Failure

Intervention

• 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

• 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 *

• Sarkis-Onofre R, Amaral Pinheiro H, Poletto-Neto V, Bergoli CD, Cenci MS, Pereira-Cenci T. Randomized controlled trial comparing glass fiber posts and cast metal posts. J Dent. 2020 May;96:103334. doi: 10.1016/j.jdent.2020.103334. Epub 2020 Apr 14.
• Skupien JA, Cenci MS, Opdam NJ, Kreulen CM, Huysmans MC, Pereira-Cenci T. Crown vs. composite for post-retained restorations: A randomized clinical trial. J Dent. 2016 May;48:34-9. doi: 10.1016/j.jdent.2016.03.007. Epub 2016 Mar 11.

Recruitment Information

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

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01461239
• Other Study ID Numbers: UFPEL-PPGO0010
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Maximiliano Sergio Cenci, Federal University of Pelotas
• Study Sponsor: Federal University of Pelotas
• Collaborators: 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

• PRS Account: Federal University of Pelotas
• Verification Date: April 2017