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%.

Study Overview

• Status: Unknown
• Conditions: Post and Core Failure
• Intervention / Treatment: Procedure: cast post and core; Procedure: fiber post and resin core - self-adhesive cement; Procedure: fiber post luted with conventional resin cement

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Pelotas, RS, Brazil, 96015560
      • Recruiting
      • School of Dentistry - Federal University of Pelotas
      • Contact: Maximiliano S Cenci, PhD; Phone Number: 134 +55 53 32226690; Email: cencims@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post and core survival	72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction with the treatment		18 months
quality of crowns and restorations (FDI criteria)		18 months
endodontic success	assessed by periapical radiographs for observation of apical lesion presence or absence	18 months

Collaborators and Investigators

• Sponsor: Federal University of Pelotas
• Collaborators: Universidade Federal de Santa Maria
• Investigators: Principal Investigator: Rogério Castilho Jacinto, PhD, Federal University of Pelotas

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: survival; debonding; endodontic treated teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: UFPEL-PPGO0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No