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

NCT ID: NCT01461239

Last Updated: 2017-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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Conditions

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Post and Core Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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cast post and core

Group Type ACTIVE_COMPARATOR

cast post and core

Intervention Type PROCEDURE

Ni-Cr alloy cast post and core luted with self-adhesive resin cement

fiber post - self-adhesive cement

Group Type EXPERIMENTAL

fiber post and resin core - self-adhesive cement

Intervention Type PROCEDURE

pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement

fiber post - conventional cement

Group Type EXPERIMENTAL

fiber post luted with conventional resin cement

Intervention Type PROCEDURE

fiber post luted with conventional etch-and-rinse adhesive system and conventional resin cement, followed by core construction with composite resin

Interventions

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fiber post and resin core - self-adhesive cement

pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement

Intervention Type PROCEDURE

cast post and core

Ni-Cr alloy cast post and core luted with self-adhesive resin cement

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Santa Maria

OTHER

Sponsor Role collaborator

Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Maximiliano Sergio Cenci

PhD, Coordinator of Clinical Trials, Graduate Program in Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tatiana Pereira-Cenci, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Rogério Castilho Jacinto, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

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School of Dentistry - Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Tatiana Pereira-Cenci, PhD

Role: CONTACT

+55 53 32226690

Maximiliano S Cenci, PhD

Role: CONTACT

5332226690 ext. 134

Facility Contacts

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Maximiliano S Cenci, PhD

Role: primary

+55 53 32226690 ext. 134

References

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Bergoli CD, Machry RV, Schwantz JK, Brondani LP, Pereira-Cenci T, Pereira GKR, Valandro LF. Survival rate and treatment success of glass fiber posts cemented with two adhesive cementation strategies after up to 106 months: a randomized clinical trial. Clin Oral Investig. 2023 May;27(5):2197-2206. doi: 10.1007/s00784-023-04939-x. Epub 2023 Mar 9.

Reference Type DERIVED
PMID: 36894666 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32302640 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26976553 (View on PubMed)

Other Identifiers

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UFPEL-PPGO0010

Identifier Type: -

Identifier Source: org_study_id

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