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

Primary Purpose

Post and Core Failure

Status

Unknown status

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

fiber post and resin core - self-adhesive cement

cast post and core

fiber post luted with conventional resin cement

About this trial

This is an interventional treatment trial for Post and Core Failure focused on measuring survival, debonding, endodontic treated teeth

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

School of Dentistry - Federal University of PelotasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

cast post and core

fiber post - self-adhesive cement

fiber post - conventional cement

Arm Description

Outcomes

Primary Outcome Measures

Post and core survival

Secondary Outcome Measures

patient satisfaction with the treatment

quality of crowns and restorations (FDI criteria)

endodontic success

assessed by periapical radiographs for observation of apical lesion presence or absence

Full Information

NCT ID

NCT01461239

First Posted

July 5, 2011

Last Updated

April 5, 2017

Sponsor

Federal University of Pelotas

Collaborators

Universidade Federal de Santa Maria

1. Study Identification

Unique Protocol Identification Number

NCT01461239

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Pelotas

Collaborators

Universidade Federal de Santa Maria

4. Oversight

Data Monitoring Committee

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post and Core Failure

Keywords

survival, debonding, endodontic treated teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cast post and core

Arm Type

Active Comparator

Arm Title

fiber post - self-adhesive cement

Arm Type

Experimental

Arm Title

fiber post - conventional cement

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

fiber post and resin core - self-adhesive cement

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

cast post and core

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

fiber post luted with conventional resin cement

Intervention Description

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

Primary Outcome Measure Information:

Title

Post and core survival

Time Frame

72 months

Secondary Outcome Measure Information:

Title

patient satisfaction with the treatment

Time Frame

18 months

Title

quality of crowns and restorations (FDI criteria)

Time Frame

18 months

Title

endodontic success

Description

assessed by periapical radiographs for observation of apical lesion presence or absence

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tatiana Pereira-Cenci, PhD

Phone

+55 53 32226690

tatiana.dds@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Maximiliano S Cenci, PhD

Phone

5332226690

Ext

134

cencims@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tatiana Pereira-Cenci, PhD

Organizational Affiliation

Federal University of Pelotas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rogério Castilho Jacinto, PhD

Organizational Affiliation

Federal University of Pelotas

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Dentistry - Federal University of Pelotas

City

Pelotas

State/Province

ZIP/Postal Code

96015560

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maximiliano S Cenci, PhD

Phone

+55 53 32226690

Ext

134

cencims@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

32302640

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.

Results Reference

derived

PubMed Identifier

26976553

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.

Results Reference

derived

Learn more about this trial

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

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