Optimizing clinical workflows for 3-D printed dentures

  • Research type

    Research Study

  • Full title

    A preliminary study, evaluating and optimizing the clinical workflows to enable a pilot RCT of 3-D printed dentures.

  • IRAS ID

    246234

  • Contact name

    Andrew Keeling

  • Contact email

    a.j.keeling@leeds.ac.uk

  • Sponsor organisation

    Faculty of Medicine and Health, University of Leeds

  • Duration of Study in the UK

    0 years, 11 months, 28 days

  • Research summary

    There is a small, but well known distortion produced when dentures are manufactured by the traditional method. Dentures are manufactured within registered dental laboratories by a process which heats acrylic resin under pressure while it is encased within plaster cast molds. The contraction that occurs when the acrylic sets, distorts the denture.
    A new manufacturing process now facilitates denture production by 3-D printing with CE marked resins within the registered dental laboratories. A Randomised Controlled Trial (RCT) would be indicated to investigate the potential benefits between these 2 ways of producing dentures. However, before we can undertake a pilot RCT, some preliminary work is required to optimise and standardise the clinical workflow. This preliminary project aims to establish the optimum clinical protocol for a pilot RCT of 3-D printed dentures.
    Specifically we want to confirm the best way to control 3 variables within the clinical workflow:
    • Firstly we wish to establish the best way of producing the virtual 'map' of the participant's mouth used to construct a 3-D image of the denture prior to printing.
    • Secondly we wish to know if using a 3-D printed 'baseplate' for the intermediate stages of denture construction is beneficial.
    • Finally we wish to know if post production painting of the dentures is necessary and/or beneficial to enhance the aesthetic appearance of the 3-D printed dentures.
    In order to investigate these 3 aspects of the clinical workflow we wish to invite 12 patients who are about to have new dentures made, to take part in the research project. After they consent, in addition to providing traditionally constructed dentures, we will construct a set of dentures by the 3-D printing process. The dentures we produce will be formally assessed by the participants, by the clinicians and by measuring the precision of the fit.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    18/YH/0288

  • Date of REC Opinion

    10 Sep 2018

  • REC opinion

    Further Information Favourable Opinion