3 Years Clinical Evaluation of 3D Printed Resin Composite Fixed Dental Prosthesis

NCT04600297 | Unknown

• 1 other identifier: 68869993-511.06-.E.150622
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years there is a rapid increase in the use of computer aided design and production. Two main types of materials are used in the production of indirect CAD/CAM restorations namely resin composite based and ceramic ones. Mechanical properties and esthetics of ceramic materials are superior to resin composites but the advantages of intraoral repair, easy adjustments and polish of resin materials are undeniable. Improvements of mechanical properties of resin-based materials resulted in the development of resin composite blocks. 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.

Conditions

Composite Resins; Dental Prosthesis

Keywords

3D printed fixed prosthesis; resin composite dental prosthesis

Outcome Measures

Primary Outcomes (1)

• Modified FDI (World Dental Federation) criteria for dental restoration assessment

  The FDI (World Dental Federation) criteria for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. The criteria were categorized into three groups: esthetic, functional and biological parameters. Each criterion can be expressed with five scores, three for acceptable and two for non-acceptable (one for reparable and one for replacement). The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome. Two independent evaluators will evaluate the restorations by using modified FDI criteria.

  3 years

Secondary Outcomes (2)

• Plaque accumulation according to the Silness & Löe (1964) Plaque Index

  3 years

• Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.

  3 years

Study Arms (1)

3D printed resin composite posterior FDP

EXPERIMENTAL

Three units posterior fixed dental prosthesis made with 3D printed resin composite material

Device: ELS Even Stronger (3D Printed Resin Composite)

Interventions

ELS Even Stronger (3D Printed Resin Composite) DEVICE

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.

3D printed resin composite posterior FDP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need for a three-unit posterior FDP
• 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.

You may not qualify if:

• Patients suffering from general health impairment
• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Saremco Dental AG: collaborator

Study Sites (1)

İstanbul Medipol University, School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

RECRUITING

Related Publications (17)

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  PMID: 16950931 BACKGROUND

• 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.

  PMID: 19280967 BACKGROUND

• 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.

  PMID: 25344335 BACKGROUND

• 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.

  PMID: 30368664 BACKGROUND

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  PMID: 27456684 BACKGROUND

• 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.

  PMID: 27928105 BACKGROUND

• 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.

  PMID: 14620019 BACKGROUND

• 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.

  PMID: 16987320 BACKGROUND

• 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.

  PMID: 18514665 BACKGROUND

• 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.

  PMID: 28422359 BACKGROUND

• 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.

  PMID: 26777092 BACKGROUND

• 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.

  PMID: 21458646 BACKGROUND

• 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.

  PMID: 20813228 BACKGROUND

• 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.

  PMID: 22575740 BACKGROUND

• 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.

  PMID: 25268039 BACKGROUND

• 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.

  PMID: 40490049 DERIVED

• 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.

  PMID: 39917685 DERIVED

Study Officials

• Mutlu Özcan, Prof.Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Muzaffer Ateş, Prof. Dr.

CONTACT

+90 212 453 48 00; mates@medipol.edu.tr

Tuğba Toz-Akalın, Assos. Prof.

CONTACT

+90 212 453 48 00; tuuuuba@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: Cases of one missing posterior tooth to be restored with 3D printed resin composite posterior FDP

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 23, 2020
• Study Start: October 10, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2024
• Last Updated: August 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)