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

Primary Purpose

MTA, Endodontically Treated Teeth, Resin Cement

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Absolute isolation
Manipulation of the resin cement with MTA
Manipulation of the resin cement without MTA
Fiber Post cimentation
Dental Prepare
Dental impression
Crown cimentation
Occlusal adjustment
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MTA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Uberlandia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Resin Cement

MTA Resin Cement

Arm Description

Resin cement without MTA

Resin cement with MTA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2018
Last Updated
April 2, 2018
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT03491527
Brief Title
Influence of Resin Cement Composition on the Longevity of Intraradicular Post of Endodontically Treated Teeth
Official Title
Influence of Resin Cement Composition on the Longevity of Intraradicular Post in the Rehabilitation of Endodontically Treated Teeth - Randomized Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
July 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MTA, Endodontically Treated Teeth, Resin Cement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Resin Cement
Arm Type
Active Comparator
Arm Description
Resin cement without MTA
Arm Title
MTA Resin Cement
Arm Type
Active Comparator
Arm Description
Resin cement with MTA
Intervention Type
Procedure
Intervention Name(s)
Absolute isolation
Intervention Description
Absolute isolation with rubber dam
Intervention Type
Procedure
Intervention Name(s)
Manipulation of the resin cement with MTA
Intervention Description
Manipulation of the resin cement with MTA according to the manufacturer's recommendations.
Intervention Type
Procedure
Intervention Name(s)
Manipulation of the resin cement without MTA
Intervention Description
Manipulation of the resin cement without MTA according to the manufacturer's recommendations.
Intervention Type
Procedure
Intervention Name(s)
Fiber Post cimentation
Intervention Description
Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.
Intervention Type
Procedure
Intervention Name(s)
Dental Prepare
Intervention Description
Confection of a indirect crown prepare with diamand burs.
Intervention Type
Procedure
Intervention Name(s)
Dental impression
Intervention Description
Dental impression whith silicone.
Intervention Type
Procedure
Intervention Name(s)
Crown cimentation
Intervention Description
Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.
Intervention Type
Procedure
Intervention Name(s)
Occlusal adjustment
Intervention Description
Analysis of the occlusion with carbon paper.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Federal University of Uberlandia
City
Uberlandia
State/Province
Minas Gerais
ZIP/Postal Code
381440617
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8040817
Citation
Assif D, Gorfil C. Biomechanical considerations in restoring endodontically treated teeth. J Prosthet Dent. 1994 Jun;71(6):565-7. doi: 10.1016/0022-3913(94)90438-3.
Results Reference
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PubMed Identifier
25628659
Citation
Bahari M, Savadi Oskoee S, Kimyai S, Mohammadi N, Saati Khosroshahi E. Effect of Light Intensity on the Degree of Conversion of Dual-cured Resin Cement at Different Depths with the use of Translucent Fiber Posts. J Dent (Tehran). 2014 May;11(3):248-55. Epub 2014 May 31.
Results Reference
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PubMed Identifier
15766576
Citation
Camilleri J, Montesin FE, Brady K, Sweeney R, Curtis RV, Ford TR. The constitution of mineral trioxide aggregate. Dent Mater. 2005 Apr;21(4):297-303. doi: 10.1016/j.dental.2004.05.010.
Results Reference
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PubMed Identifier
15493395
Citation
Christensen GJ. Post concepts are changing. J Am Dent Assoc. 2004 Sep;135(9):1308-10. doi: 10.14219/jada.archive.2004.0406.
Results Reference
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PubMed Identifier
15829892
Citation
Duarte MA, De Oliveira Demarchi AC, Yamashita JC, Kuga MC, De Campos Fraga S. Arsenic release provided by MTA and Portland cement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 May;99(5):648-50. doi: 10.1016/j.tripleo.2004.09.015.
Results Reference
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PubMed Identifier
8151240
Citation
Lee SJ, Monsef M, Torabinejad M. Sealing ability of a mineral trioxide aggregate for repair of lateral root perforations. J Endod. 1993 Nov;19(11):541-4. doi: 10.1016/S0099-2399(06)81282-3.
Results Reference
background
PubMed Identifier
18422584
Citation
Santos-Filho PC, Castro CG, Silva GR, Campos RE, Soares CJ. Effects of post system and length on the strain and fracture resistance of root filled bovine teeth. Int Endod J. 2008 Jun;41(6):493-501. doi: 10.1111/j.1365-2591.2008.01383.x. Epub 2008 Apr 12.
Results Reference
background
PubMed Identifier
27377433
Citation
von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. French, German.
Results Reference
background

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

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