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

Primary Purpose

Dental Materials, Tooth, Nonvital

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
local anesthesia
Tooth restored using SFRC filling
Tooth restored using Ceramic indirect endocrown
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Materials focused on measuring fiber-reinforced composite

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    SFRC direct filling

    CEREC endocrown

    Arm Description

    Restoration of endodontically treated tooth Endodontically treated molars are restored with direct composite restorations, using a short-FRC base filling.

    Restoration of endodontically treated tooth Endodontically treated molars are restored with indirect ceramic CAD/CAM restorations.

    Outcomes

    Primary Outcome Measures

    Restoration failure detected at clinical follow-up examination
    Observer scores the restoration having a fracture or detachment that requires remaking of the restoration.

    Secondary Outcome Measures

    Restoration fracture detected at clinical follow-up examination
    Observer scores the restoration having a fracture, which needs a repair
    Restored tooth demonstrates with an endodontic complication needing removal of restoration or tooth. Clinical and radiographic examination requiered.
    an endodontic infection requiring an endodontic retreatement or the loss of the tooth due to an endodontic infection
    Observer scores the restoration having with dental caries at clinical follow-up investigation
    Secondary dentinal caries, that requires restorative treatment, is observed adjacent to the restoration

    Full Information

    First Posted
    October 29, 2017
    Last Updated
    October 4, 2019
    Sponsor
    University of Turku
    Collaborators
    GC Europe, City of Turku
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04111003
    Brief Title
    Fiber-reinforced Composite Core Filling in the Restoration of Endodontically Treated Molars - a Clinical Study.
    Acronym
    sFRCendocr
    Official Title
    Fiber-reinforced Composite Core Filling in the Restoration of Endodontically Treated Molars - a Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 11, 2012 (Actual)
    Primary Completion Date
    February 12, 2017 (Actual)
    Study Completion Date
    February 6, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Turku
    Collaborators
    GC Europe, City of Turku

    4. Oversight

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

    5. Study Description

    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.
    Detailed Description
    INTRODUCTION Composite resins are routinely used for restoring vital and non-vital posterior teeth by most practitioners in Finland. Various clinical studies have found that the three main reasons for failure of direct composite fillings are secondary caries, wear and fracture of composite resin especially at molar region (1, 2, 3). Non-vital (endodontically treated) teeth are structurally compromised and their restoration is associated with technical failures such as debonding and vertical root fractures (4). Techniques, like root canal post insertion, that are used to overcome these problems, are time consuming and may even further increase the risk for root fractures. This study is a continuum on material development conducted at the the Department of Prosthetic Dentistry, Biomaterials Science and Turku Clinical Biomaterials Centre - TCBC, University of Turku, in collaboration with TEKES (Technology Development Center of Finland) and StickTech (Turku, Finland). The data obtained has shown that, the use of a bilayered structure consisting of a fiber-reinforced composite substructure (core FRC) combined with an upper layer of conventional restorative composite, increases the fracture load of a restoration significantly (5,6 and 7). This newly developed material has increased mechanical properties when compared to conventional materials, while maintaining its clinical applicability. Moreover, volumetric polymerization shrinkage of the core FRC is found to be lower than commercially available composites (<1.8% for the new FRC-material; 2.0% for a commercial composite Z250) (8). This may be expected to result in less marginal leakage and secondary caries in long term. With this backround a multidirectional short-fiber composite (everX, StickTech) has been introduced as a base material (FRC substructure) for large cavities in vital or non-vital teeth. The investigators in vitro experiments have shown that the FRC substructure retains and significantly reinforces composite crowns in endodontically treated molars. Moreover, in case of failure, the presence of the FRC substructure seems to orient the fracture propagation and result in more easily restorable fractures. Application on the core 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. In a recently published clinical pilot study the investigators have reported successful 1 year results of this technique (9). Ceramic onlay-restorations, so called "endo-crowns", are currently used to restore endodontically treated molars with similar indications (without root canal involvement). Case studies have reported good clinical results with this type of method (10). The use of an indirect technique (multiple patient visits), material and technical fabrication costs make this treatment modality, however, more costly and not in the reach of every patient. . AIM OF STUDY The purpose of this study is to compare the clinical performance of endodontically treated molars restored with either direct composite restorations with a FRC subtructure, or with indirect full-ceramic onlay restorations, i.e. endo-crowns. Specific study hypotheses are: The five year survival of direct FRC restorations is equal to that of ceramic endo-crowns Direct FRC restorations and ceramic endo-crowns perform equally with regard to marginal integrity fracture resistance occlusal wear secondary caries Less bleeding on probing is present around ceramic restorations when compared to composite restorations Less chair-side time is needed to restore a tooth with a direct FRC restoration than with a ceramic endo-crown MATERIALS AND METHODS The study will be carried out at the Institute of Dentistry of Turku University at Dentalia building (Lemminkäisenkatu 2, Turku). Subjects are enrolled among the patients of the undergraduate dental students (Dental teaching clinic, Turku city health care). Operators are experienced dental practitioners. Ethical committee approval was obtained (20.6.2006) form the Joint Commission on Ethics of the Turku University and The Turku University Hospital. A written informed concent will be obtained from all participants prior to their enrolment in the study. Exclusion/inclusion is based on anamnestic data, clinical and radiographic examination. Exlusion criteria at patient level are known nocturnal bruxism, active periodontal disease and poor oral hygiene. Exclusion criteria at tooth level are: periapical pathosis, root canal filling >3 mm short from apex, vertical fracture observed in cavum dentin, more than 50% of cavity margin situated subgingivally, less than 2mm of coronal tooth tissue present and lack of occluding antagonist. Alltogether 30 restorations, 15 direct composite restorations and 15 ceramic restorations, are made in endodontically treated posterior teeth (molars and premolars). Study teeth are randomly divided into two groups, the other receiving direct composite fillings and the other indirect ceramic fillings. In the composite group root canal orifices and the pulpal chamber is filled with the FRC substructure material forming a core restoration (everX, StickTech) and covered with an upperlayer of commercial restorative composite (Filtek Supreme 3M ESPE). In the ceramic group teeth are prepared for endo-crowns and optical impressions are made. CAD/CAM ceramic fillings are fabricated (CEREC, Dentsply Sirona) and subsequently cemented with resin cement at place. Special attention is payed to finishing and occlusal adjustment of the studied restorations. Chair-side time consumed in the making of the studied restorations is recorded in order to determine the cost-effectiveness of the methods. In addition to clinical examination, two to three visits per patient are required to fabricate the studied restorations. Impressions of the preparations are taken of all teeth to study the effect of remaining coronal tissue on the clinical survival. Patients are recalled and restorations examined at yearly follow-up visits up to five years. The clinical appearance, marginal integrity, fracture resistance, occlusal wear and color stability as well as the condition of marginal periodontal tissues close to the studied materials are assessed. X-rays at baseline, 2 and 5 year follow-up visits, are taken to determine the periapical status of the teeth and the intergrity of the restorations. Accordingly, impressions are taken and gypsum models casted to study the occlusal wear rate of the restorations. STUDY TIMETABLE Patient enrolling and examination, fall 2012 Clinical procedures, fabrication of restorations, 2012 - 2013 Follow-up examinations, 2013 - 2018 Analysing and reporting of the results, , 2018-2019

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Materials, Tooth, Nonvital
    Keywords
    fiber-reinforced composite

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SFRC direct filling
    Arm Type
    Experimental
    Arm Description
    Restoration of endodontically treated tooth Endodontically treated molars are restored with direct composite restorations, using a short-FRC base filling.
    Arm Title
    CEREC endocrown
    Arm Type
    Active Comparator
    Arm Description
    Restoration of endodontically treated tooth Endodontically treated molars are restored with indirect ceramic CAD/CAM restorations.
    Intervention Type
    Procedure
    Intervention Name(s)
    local anesthesia
    Intervention Description
    administering local anesthesia in the region of the planned restorative procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth restored using SFRC filling
    Intervention Description
    Restoration of an endodontivally treated molar using a shor-fiber base filling and veneering composite
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth restored using Ceramic indirect endocrown
    Intervention Description
    Restoration of an endodontically treated molar using a ceramic indirect restoration
    Primary Outcome Measure Information:
    Title
    Restoration failure detected at clinical follow-up examination
    Description
    Observer scores the restoration having a fracture or detachment that requires remaking of the restoration.
    Time Frame
    5 years
    Secondary Outcome Measure Information:
    Title
    Restoration fracture detected at clinical follow-up examination
    Description
    Observer scores the restoration having a fracture, which needs a repair
    Time Frame
    5 years
    Title
    Restored tooth demonstrates with an endodontic complication needing removal of restoration or tooth. Clinical and radiographic examination requiered.
    Description
    an endodontic infection requiring an endodontic retreatement or the loss of the tooth due to an endodontic infection
    Time Frame
    5 years
    Title
    Observer scores the restoration having with dental caries at clinical follow-up investigation
    Description
    Secondary dentinal caries, that requires restorative treatment, is observed adjacent to the restoration
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pekka K Vallittu, professor
    Organizational Affiliation
    University of Turku
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15680997
    Citation
    Sarrett DC. Clinical challenges and the relevance of materials testing for posterior composite restorations. Dent Mater. 2005 Jan;21(1):9-20. doi: 10.1016/j.dental.2004.10.001.
    Results Reference
    background
    PubMed Identifier
    16580114
    Citation
    van Dijken JW, Sunnegardh-Gronberg K. Fiber-reinforced packable resin composites in Class II cavities. J Dent. 2006 Nov;34(10):763-9. doi: 10.1016/j.jdent.2006.02.003. Epub 2006 Mar 31.
    Results Reference
    background
    PubMed Identifier
    15622879
    Citation
    Manhart J. Direct composite restorations in posterior region: a case history using a nanohybrid composite. Dent Today. 2004 Nov;23(11):66, 68-70. No abstract available.
    Results Reference
    background
    PubMed Identifier
    7658393
    Citation
    Torbjorner A, Karlsson S, Odman PA. Survival rate and failure characteristics for two post designs. J Prosthet Dent. 1995 May;73(5):439-44. doi: 10.1016/s0022-3913(05)80072-1.
    Results Reference
    background
    PubMed Identifier
    16150524
    Citation
    Garoushi S, Lassila LV, Tezvergil A, Vallittu PK. Load bearing capacity of fibre-reinforced and particulate filler composite resin combination. J Dent. 2006 Mar;34(3):179-84. doi: 10.1016/j.jdent.2005.05.010. Epub 2005 Sep 8.
    Results Reference
    background
    PubMed Identifier
    16957785
    Citation
    Garoushi SK, Lassila LV, Tezvergil A, Vallittu PK. Fiber-reinforced composite substructure: load-bearing capacity of an onlay restoration and flexural properties of the material. J Contemp Dent Pract. 2006 Sep 1;7(4):1-8.
    Results Reference
    background
    PubMed Identifier
    15237878
    Citation
    Fennis WM, Kuijs RH, Kreulen CM, Verdonschot N, Creugers NH. Fatigue resistance of teeth restored with cuspal-coverage composite restorations. Int J Prosthodont. 2004 May-Jun;17(3):313-7.
    Results Reference
    background
    PubMed Identifier
    16239026
    Citation
    Tezvergil A, Lassila LV, Vallittu PK. The effect of fiber orientation on the polymerization shrinkage strain of fiber-reinforced composites. Dent Mater. 2006 Jul;22(7):610-6. doi: 10.1016/j.dental.2005.05.017. Epub 2005 Oct 18.
    Results Reference
    background
    PubMed Identifier
    22408696
    Citation
    Garoushi S, Tanner J, Vallittu P, Lassila L. Preliminary clinical evaluation of short fiber-reinforced composite resin in posterior teeth: 12-months report. Open Dent J. 2012;6:41-5. doi: 10.2174/1874210601206010041. Epub 2012 Jan 6.
    Results Reference
    background
    PubMed Identifier
    20691334
    Citation
    van Dijken JW, Hasselrot L. A prospective 15-year evaluation of extensive dentin-enamel-bonded pressed ceramic coverages. Dent Mater. 2010 Sep;26(9):929-39. doi: 10.1016/j.dental.2010.05.008. Epub 2010 Jun 17.
    Results Reference
    background

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

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