3 Years Clinical Evaluation of 3D Printed Resin Composite Fixed Dental Prosthesis
NCT ID: NCT04600297
Last Updated: 2021-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2020-10-10
2024-03-01
Brief Summary
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3D printed restorations, which can be performed as chairside in one session can be manufactured in case of any broken / chipping / debonding cases, without the need for repeated impression making. This saves time for the patient and the clinician. By using these 3D resin-based composite materials in fixed partial dentures, intraoral repairs can be performed. In addition, the high costs of burs and possible damage to the CAD/CAM blocks used in ceramic milling are eliminated when restoration are manufactured in printers with the DLP technology.
The objective of this study was to evaluate the clinical outcome of 3D printed posterior resin composite FDP restorations up to 3 years.
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Detailed Description
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Patients participating in the investigation are going to be informed by the "Clinicians" on the background and risk of the investigation. Patients have to give their written consent to participate in the investigation.
The treatment procedure includes the following steps:
Preparation scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing and cementation of the FDP.
The control procedures:
Two weeks after cementation, baseline control will be performed according to USPHS and FDI 2. The restorations will be evaluated at 3 years recall.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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3D printed resin composite posterior FDP
Three units posterior fixed dental prosthesis made with 3D printed resin composite material
ELS Even Stronger (3D Printed Resin Composite)
Missing of one premolar cases will be restored using the 3D Printed resin composite (ELS Even Stronger, Saremco, Switzerland). The steps of the procedure: Preparation, scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing, cementation.
Interventions
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ELS Even Stronger (3D Printed Resin Composite)
Missing of one premolar cases will be restored using the 3D Printed resin composite (ELS Even Stronger, Saremco, Switzerland). The steps of the procedure: Preparation, scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing, cementation.
Eligibility Criteria
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Inclusion Criteria
* One missing tooth from the second premolar to the second molar where 1st molar is missing (pontic replacing 1st molar)
* Presence of opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth)
* Only FPD s with end abutments (No cantilever)
* Sufficient length of the clinical crown (\>5 mm)
* No obvious untreated caries, dental health problems (regularly checked by a dentist)
* Good or moderate oral hygiene (plaque score of less than 30% in anterior region be-fore treatment)
* No untreated periodontal disease (only DPSI 1, 2)
* Abutment teeth are vital or endodontically treated with a sealed root filling to the apical region, and have to be without apical periodontitis for the past 6 months.
* Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
* Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.
Exclusion Criteria
* Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or - Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
* Endodontic treatment with extensive loss of tooth tissue
* Subjects who presented with severe wear facets and/or reported parafunctional activi-ties such as clenching or nocturnal bruxism
* Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
* Subjects who were pregnant during the duration of the study
* Subjects who are known to be allergic to the ingredients of resin materials
18 Years
ALL
Yes
Sponsors
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Saremco Dental AG
INDUSTRY
Istanbul Medipol University Hospital
OTHER
Responsible Party
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Mehmet Muzaffer Ateş
Prof.Dr.
Principal Investigators
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Mutlu Özcan, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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İstanbul Medipol University, School of Dentistry
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Rekow ED. Dental CAD/CAM systems: a 20-year success story. J Am Dent Assoc. 2006 Sep;137 Suppl:5S-6S. doi: 10.14219/jada.archive.2006.0396. No abstract available.
Miyazaki T, Hotta Y, Kunii J, Kuriyama S, Tamaki Y. A review of dental CAD/CAM: current status and future perspectives from 20 years of experience. Dent Mater J. 2009 Jan;28(1):44-56. doi: 10.4012/dmj.28.44.
Ruse ND, Sadoun MJ. Resin-composite blocks for dental CAD/CAM applications. J Dent Res. 2014 Dec;93(12):1232-4. doi: 10.1177/0022034514553976. Epub 2014 Oct 24.
Zimmermann M, Ender A, Egli G, Ozcan M, Mehl A. Fracture load of CAD/CAM-fabricated and 3D-printed composite crowns as a function of material thickness. Clin Oral Investig. 2019 Jun;23(6):2777-2784. doi: 10.1007/s00784-018-2717-2. Epub 2018 Oct 27.
Alharbi A, Ardu S, Bortolotto T, Krejci I. Stain susceptibility of composite and ceramic CAD/CAM blocks versus direct resin composites with different resinous matrices. Odontology. 2017 Apr;105(2):162-169. doi: 10.1007/s10266-016-0258-1. Epub 2016 Jul 25.
Kamonwanon P, Hirose N, Yamaguchi S, Sasaki JI, Kitagawa H, Kitagawa R, Thaweboon S, Srikhirin T, Imazato S. SiO2-nanocomposite film coating of CAD/CAM composite resin blocks improves surface hardness and reduces susceptibility to bacterial adhesion. Dent Mater J. 2017 Jan 31;36(1):88-94. doi: 10.4012/dmj.2016-135. Epub 2016 Dec 6.
Mitra SB, Wu D, Holmes BN. An application of nanotechnology in advanced dental materials. J Am Dent Assoc. 2003 Oct;134(10):1382-90. doi: 10.14219/jada.archive.2003.0054.
Deliperi S, Bardwell DN. Clinical evaluation of direct cuspal coverage with posterior composite resin restorations. J Esthet Restor Dent. 2006;18(5):256-65; discussion 266-7. doi: 10.1111/j.1708-8240.2006.00033.x.
Yesil ZD, Alapati S, Johnston W, Seghi RR. Evaluation of the wear resistance of new nanocomposite resin restorative materials. J Prosthet Dent. 2008 Jun;99(6):435-43. doi: 10.1016/S0022-3913(08)60105-5.
Zimmermann M, Koller C, Reymus M, Mehl A, Hickel R. Clinical Evaluation of Indirect Particle-Filled Composite Resin CAD/CAM Partial Crowns after 24 Months. J Prosthodont. 2018 Oct;27(8):694-699. doi: 10.1111/jopr.12582. Epub 2017 Apr 19.
Shembish FA, Tong H, Kaizer M, Janal MN, Thompson VP, Opdam NJ, Zhang Y. Fatigue resistance of CAD/CAM resin composite molar crowns. Dent Mater. 2016 Apr;32(4):499-509. doi: 10.1016/j.dental.2015.12.005. Epub 2016 Jan 8.
Schlichting LH, Maia HP, Baratieri LN, Magne P. Novel-design ultra-thin CAD/CAM composite resin and ceramic occlusal veneers for the treatment of severe dental erosion. J Prosthet Dent. 2011 Apr;105(4):217-26. doi: 10.1016/S0022-3913(11)60035-8.
Magne P, Schlichting LH, Maia HP, Baratieri LN. In vitro fatigue resistance of CAD/CAM composite resin and ceramic posterior occlusal veneers. J Prosthet Dent. 2010 Sep;104(3):149-57. doi: 10.1016/S0022-3913(10)60111-4.
Magne P, Stanley K, Schlichting LH. Modeling of ultrathin occlusal veneers. Dent Mater. 2012 Jul;28(7):777-82. doi: 10.1016/j.dental.2012.04.002. Epub 2012 May 9.
El-Damanhoury HM, Haj-Ali RN, Platt JA. Fracture resistance and microleakage of endocrowns utilizing three CAD-CAM blocks. Oper Dent. 2015 Mar-Apr;40(2):201-10. doi: 10.2341/13-143-L. Epub 2014 Sep 30.
Hobbi P, Ordueri TM, Ozturk-Bozkurt F, Toz-Akalin T, Ates MM, Ozcan M. Assessing the performance of 3D-printed resin composite posterior fixed dental prostheses: A 3-year prospective clinical trial. J Dent. 2025 Sep;160:105887. doi: 10.1016/j.jdent.2025.105887. Epub 2025 Jun 7.
Hobbi P, Ordueri TM, Ozturk-Bozkurt F, Toz-Akalin T, Ates M, Ozcan M. 3D-printed resin composite posterior fixed dental prosthesis: a prospective clinical trial up to 1 year. Front Dent Med. 2024 Jun 4;5:1390600. doi: 10.3389/fdmed.2024.1390600. eCollection 2024.
Other Identifiers
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68869993-511.06-.E.150622
Identifier Type: -
Identifier Source: org_study_id
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