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Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts
This study is currently recruiting participants.
Verified April 2017 by Maximiliano Sergio Cenci, Federal University of Pelotas
Sponsor:
Federal University of Pelotas
Collaborator:
Universidade Federal de Santa Maria
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT01461239
First received: July 5, 2011
Last updated: April 5, 2017
Last verified: April 2017
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Purpose
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 | Intervention | 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 Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Maximiliano Sergio Cenci, Federal University of Pelotas:
Primary Outcome Measures:
- Post and core survival [ Time Frame: 72 months ]
Secondary Outcome Measures:
- patient satisfaction with the treatment [ Time Frame: 18 months ]
- quality of crowns and restorations (FDI criteria) [ Time Frame: 18 months ]
- endodontic success [ Time Frame: 18 months ]assessed by periapical radiographs for observation of apical lesion presence or absence
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461239
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | July 5, 2011 |
| Last Updated: | April 5, 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 |
ClinicalTrials.gov processed this record on August 17, 2017