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Fiber-reinforced Composite Core Filling in the Restoration of Endodontically Treated Molars - a Clinical Study. (sFRCendocr)

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: NCT04111003
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
GC Europe
City of Turku
Information provided by (Responsible Party):
Johanna Tanner, University of Turku

Brief Summary:

A short fiber reinforced composite base filling material has been shown to improve the strength of a direct composite filling significantly. It prevents fracture propagation and reduces shrinkage strain. These features are needed especially in endodontically treated molars, as root-canal treated teeth are structurally compromised and their restoration is associated with technical failures such as debonding and vertical root fractures.

Application on this core fiber-reinforced composite (FRC) material is simplified when compared to post and core techniques commonly used to restore endodontically treated teeth. Clinically, the use of core FRC offers a cost-effective way to restore endodontically treated molars without root canal involvement.

The purpose of this study is to compare the clinical performance of endodontically treated molars restored with either direct composite restorations with a FRC substructure, or with indirect full-ceramic onlay restorations, i.e. endo-crowns.


Condition or disease Intervention/treatment Phase
Dental Materials Tooth, Nonvital Procedure: local anesthesia Procedure: Tooth restored using SFRC filling Procedure: Tooth restored using Ceramic indirect endocrown Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fiber-reinforced Composite Core Filling in the Restoration of Endodontically Treated Molars - a Clinical Study
Actual Study Start Date : December 11, 2012
Actual Primary Completion Date : February 12, 2017
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: SFRC direct filling
Restoration of endodontically treated tooth Endodontically treated molars are restored with direct composite restorations, using a short-FRC base filling.
Procedure: local anesthesia
administering local anesthesia in the region of the planned restorative procedure

Procedure: Tooth restored using SFRC filling
Restoration of an endodontivally treated molar using a shor-fiber base filling and veneering composite

Active Comparator: CEREC endocrown
Restoration of endodontically treated tooth Endodontically treated molars are restored with indirect ceramic CAD/CAM restorations.
Procedure: local anesthesia
administering local anesthesia in the region of the planned restorative procedure

Procedure: Tooth restored using Ceramic indirect endocrown
Restoration of an endodontically treated molar using a ceramic indirect restoration




Primary Outcome Measures :
  1. Restoration failure detected at clinical follow-up examination [ Time Frame: 5 years ]
    Observer scores the restoration having a fracture or detachment that requires remaking of the restoration.


Secondary Outcome Measures :
  1. Restoration fracture detected at clinical follow-up examination [ Time Frame: 5 years ]
    Observer scores the restoration having a fracture, which needs a repair

  2. Restored tooth demonstrates with an endodontic complication needing removal of restoration or tooth. Clinical and radiographic examination requiered. [ Time Frame: 5 years ]
    an endodontic infection requiring an endodontic retreatement or the loss of the tooth due to an endodontic infection

  3. Observer scores the restoration having with dental caries at clinical follow-up investigation [ Time Frame: 5 years ]
    Secondary dentinal caries, that requires restorative treatment, is observed adjacent to the restoration



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • need for a restoration in a endodontically treated upper of lower molar tooth
  • adequate coronal tooth substance present for an adhesive restorative technique

Exclusion Criteria:

  • propable sleep bruxism
  • active periodontitis
  • disability to performs oral hygiene measures
  • periapical parodontitis in the study tooth
  • low quality of root canal obturation
  • fracture-line detected at cavity preparation
  • no enamel present
  • less than 2mm of coronal tissue present in average
  • no opposing tooth

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): NCT04111003


Sponsors and Collaborators
University of Turku
GC Europe
City of Turku
Investigators
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Study Chair: Pekka K Vallittu, professor University of Turku
Publications:

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Responsible Party: Johanna Tanner, Associate professor, Department of Prosthetic Dentistry and Stomatognathic Physiology, University of Turku
ClinicalTrials.gov Identifier: NCT04111003    
Other Study ID Numbers: 20341 601350
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
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
Keywords provided by Johanna Tanner, University of Turku:
fiber-reinforced composite
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs