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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 : 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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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%.

Condition or disease Intervention/treatment 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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
Study Start Date : July 2009
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Post and core survival [ Time Frame: 72 months ]

Secondary Outcome Measures :
  1. patient satisfaction with the treatment [ Time Frame: 18 months ]
  2. quality of crowns and restorations (FDI criteria) [ Time Frame: 18 months ]
  3. endodontic success [ Time Frame: 18 months ]
    assessed by periapical radiographs for observation of apical lesion presence or absence


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Keywords provided by Maximiliano Sergio Cenci, Federal University of Pelotas:
survival
debonding
endodontic treated teeth

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