Clinical Trial: A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: A Proof of Concept for All-ceramic Zirconia Resin Bonded Bridges for Canine, Premolar and Short Span Posterior Teeth Official Title:

Brief Summary:

Trial Design - Objectives and Purpose The aim of this study is to perform a proof of concept for the successful retention and outcome measures of zirconia RBBs for the replacement of missing canine or posterior teeth (6-8mm span) and that they will exhibit similar survival rates (95%) as metal ceramic RBBs over 3 years and short term (Botelho 2006).

The use of monolithic extra-coronal zirconia RBBs in the posterior region does not appear to have been reported in the literature (A search pf Pub Med and Google Scholar has not shown any similar studies that have been published - pubmed.gov; Keywords: "zirconia", "resin", "clinical" assessed on 17/10/2015 AND google scholar; Keywords: "zirconia", "resin bonded fixed partial denture", "resin bonded fixed dental prosthesis", "Maryland", "resin bonded bridge" "posterior", "clinical") In addition, currently there appear to be no clinical trials planned or finished in this area (clinicaltrial.gov; Keywords: "zirconia", "resin" assessed on 17/10/2015) using zirconia RBBs in the posterior region. This reveals that there is a gap in the literature on the use of zirconia for replacing posterior teeth with such prostheses.

The primary outcome measures would be: success ie. prosthesis retention ie. does not fall out

The secondary outcome measures would be:

  • complications of the prosthesis such as tipping, drifting or fracture.
  • patient centered outcomes (satisfaction and oral health related quality of life) on the RBBs The hypothesis is that 2-unit cantilevered zirconia RBBs will be as successful as current

    Detailed Summary:
    Sponsor: The University of Hong Kong

    Current Primary Outcome: Zirconia bridge clinical retention/survival rate, that is the presence of the zirconia bridge in patients' mouth in review appointment and will be calculated as a percentage of the total bridges placed as well as presented in Kaplan Meier survival curve. [ Time Frame: 3 years ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Patient satisfaction in terms of oral health related quality of life (OHrQoL) using Oral Health Impact Profile (OHIP) 49-items questionnaire [ Time Frame: 3 years ]
    • Patient satisfaction in terms of bridge satisfaction in visual analogue scale (VAS) [ Time Frame: 3 years ]
    • Complications/adverse outcome associated with Zr bridge reported by patient and detected by clinical assessors [ Time Frame: 3 years ]


    Original Secondary Outcome: Same as current

    Information By: The University of Hong Kong

    Dates:
    Date Received: May 20, 2016
    Date Started: January 2016
    Date Completion:
    Last Updated: June 2, 2016
    Last Verified: June 2016