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

Post and Core Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01461239
• Other study ID #: UFPEL-PPGO0010
• Status: Recruiting
• Phase: Phase 3
• First received: July 5, 2011
• Last updated: April 5, 2017
• Start date: July 2009
• Est. completion date: July 2018

Study information

• Verified date: April 2017
• Source: Federal University of Pelotas
• Contact: Tatiana Pereira-Cenci, PhD
• Phone: +55 53 32226690
• Email: tatiana.dds[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Post and Core Failure
• Tooth, Nonvital

Intervention

Procedure:
• fiber post and resin core - self-adhesive cement
pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement
• cast post and core
Ni-Cr alloy cast post and core luted with self-adhesive resin cement
• 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

Locations

Country	Name	City	State
Brazil	School of Dentistry - Federal University of Pelotas	Pelotas	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Pelotas	Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post and core survival		72 months
Secondary	patient satisfaction with the treatment		18 months
Secondary	quality of crowns and restorations (FDI criteria)		18 months
Secondary	endodontic success	assessed by periapical radiographs for observation of apical lesion presence or absence	18 months