Clinical trial NCT01461239: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post and Core Failure
Keywords: survival
debonding
endodontic treated teeth
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Santa Maria
First posted: 2011-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


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

Primary outcomes:
measure: Post and core survival
timeFrame: 72 months
Secondary outcomes:
measure: patient satisfaction with the treatment
timeFrame: 18 months
measure: quality of crowns and restorations (FDI criteria)
timeFrame: 18 months
measure: endodontic success
timeFrame: 18 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: School of Dentistry - Federal University of Pelotas
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Tatiana Pereira-Cenci, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Pelotas
name: Rogério Castilho Jacinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.