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Influence of Resin Cement Composition on the Longevity of Intraradicular Post of Endodontically Treated Teeth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491527
Recruitment Status : Unknown
Verified April 2018 by PAULO VINICIUS SOARES, Federal University of Uberlandia.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
PAULO VINICIUS SOARES, Federal University of Uberlandia

Brief Summary:
The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Condition or disease Intervention/treatment Phase
MTA Endodontically Treated Teeth Resin Cement Procedure: Absolute isolation Procedure: Manipulation of the resin cement with MTA Procedure: Manipulation of the resin cement without MTA Procedure: Fiber Post cimentation Procedure: Dental Prepare Procedure: Dental impression Procedure: Crown cimentation Procedure: Occlusal adjustment Not Applicable

Detailed Description:
Endodontically treated teeth present an increased risk of fracture and are usually related to extensive carious processes or trauma that promote major coronary destruction. In such situations, it may be necessary to indicate intra-radicular retainers, such as fiberglass pins, to retain the restorative material. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Twenty participants with at least two teeth with endodontic treatment with need intraradicular post cementation and confection of indirect dental crown (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to resin cement composition (with and without mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Resin Cement Composition on the Longevity of Intraradicular Post in the Rehabilitation of Endodontically Treated Teeth - Randomized Clinical Trials
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : July 30, 2019

Arm Intervention/treatment
Active Comparator: Conventional Resin Cement
Resin cement without MTA
Procedure: Absolute isolation
Absolute isolation with rubber dam

Procedure: Manipulation of the resin cement without MTA
Manipulation of the resin cement without MTA according to the manufacturer's recommendations.

Procedure: Fiber Post cimentation
Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.

Procedure: Dental Prepare
Confection of a indirect crown prepare with diamand burs.

Procedure: Dental impression
Dental impression whith silicone.

Procedure: Crown cimentation
Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.

Procedure: Occlusal adjustment
Analysis of the occlusion with carbon paper.

Active Comparator: MTA Resin Cement
Resin cement with MTA
Procedure: Absolute isolation
Absolute isolation with rubber dam

Procedure: Manipulation of the resin cement with MTA
Manipulation of the resin cement with MTA according to the manufacturer's recommendations.

Procedure: Fiber Post cimentation
Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.

Procedure: Dental Prepare
Confection of a indirect crown prepare with diamand burs.

Procedure: Dental impression
Dental impression whith silicone.

Procedure: Crown cimentation
Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.

Procedure: Occlusal adjustment
Analysis of the occlusion with carbon paper.




Primary Outcome Measures :
  1. Success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns with a 1 year follow up. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy volunteers;
  • Presence of at least two teeth with endodontc treatment;
  • Presence of at least two teeth with indication of total crowns;
  • Good oral hygiene.

Exclusion Criteria:

  • Dentures or orthodontics;
  • Presence of periodontal disease
  • Presence of parafunctional habits
  • Presence of systemic disease
  • Constant use of analgesic and or anti-inflammatory
  • Allergic response to dental products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491527


Locations
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Brazil
Federal University of Uberlandia
Uberlandia, Minas Gerais, Brazil, 381440617
Sponsors and Collaborators
Federal University of Uberlandia

Publications:
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Responsible Party: PAULO VINICIUS SOARES, Director of NCCL Research Group, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT03491527    
Other Study ID Numbers: 2.570.182
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Pemetrexed
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors