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
About this trial
This is an interventional treatment trial for Dental Materials focused on measuring fiber-reinforced composite
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
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
NCT ID
NCT04111003
First Posted
October 29, 2017
Last Updated
October 4, 2019
Sponsor
University of Turku
Collaborators
GC Europe, City of Turku
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
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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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