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

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ClinicalTrials.gov Identifier: NCT04600297
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
Saremco Dental AG
Information provided by (Responsible Party):
Mehmet Muzaffer Ateş, Istanbul Medipol University Hospital

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.


Condition or disease Intervention/treatment Phase
Composite Resins Dental Prosthesis Device: ELS Even Stronger (3D Printed Resin Composite) Not Applicable

Detailed Description:

The study will be carried out as a prospective study, with assessment of the restorations after three year. The project includes 3-unit posterior fixed dental prosthesis (FDP) for 70 cases.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cases of one missing posterior tooth to be restored with 3D printed resin composite posterior FDP
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of 3D Printed Resin Composite Posterior Fixed Dental Prosthesis: A Prospective Clinical Trial up to 3 Years
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: 3D printed resin composite posterior FDP
Three units posterior fixed dental prosthesis made with 3D printed resin composite material
Device: 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.




Primary Outcome Measures :
  1. Modified FDI (World Dental Federation) criteria for dental restoration assessment [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Plaque accumulation according to the Silness & Löe (1964) Plaque Index [ Time Frame: 3 years ]

    0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent

  2. Gingival Inflammation according to the Silness & Löe (1964) Gingival Index. [ Time Frame: 3 years ]

    0 = Normal gingival.

    1. = Mild inflammation-slight change in colour, slight oedema. No bleeding on probing
    2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing.
    3. = Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT04600297


Contacts
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Contact: Mehmet Muzaffer Ateş, Prof. Dr. +90 212 453 48 00 ext 4969 mates@medipol.edu.tr
Contact: Tuğba Toz-Akalın, Assos. Prof. +90 212 453 48 00 ext 4946 tuuuuba@hotmail.com

Locations
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Turkey
İstanbul Medipol University, School of Dentistry Recruiting
Istanbul, Turkey, 34083
Contact: Muzaffer Ateş, Prof.Dr.    +905326134765    mates@medipol.edu.tr   
Contact: Tuğba Toz, Assos. Prof.    +905433242554    tuuuuba2008@hotmail.com   
Sponsors and Collaborators
Istanbul Medipol University Hospital
Saremco Dental AG
Investigators
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Principal Investigator: Mutlu Özcan, Prof.Dr. University of Zurich
Publications:

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Responsible Party: Mehmet Muzaffer Ateş, Prof.Dr., Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT04600297    
Other Study ID Numbers: 68869993-511.06-.E.150622
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
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 Mehmet Muzaffer Ateş, Istanbul Medipol University Hospital:
3D printed fixed prosthesis
resin composite dental prosthesis