Clinical Trial: Clinical Trial of Zirconia and Metal Adhesive Bridges

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Single-centre Randomised Controlled Clinical Trial of Zirconia-based Versus Metal-based Adhesive Bridges for Replacing 2 Missing Teeth or Less in Adults.

Brief Summary:

Adhesive bridges are becoming popular in patients with congenitally missing teeth and these are type of bridges that can be done with only minimal or with no preparation to replace the missing tooth/teeth. The best clinical gain is the minimal tooth preparation or no need for the removal of tooth substance. Treatment for this type of bridges does not usually require anaesthesia. In addition, adhesive bridges can provide reasonable aesthetical outcome with minimal cost and reduced chair time.

The biggest issue is that high failure rate in the long term, and gray colour shining through the metal wing cemented onto the abutment tooth. This can compromise the aesthetical outcome. The aesthetical problem can be solved by the use of zirconia all ceramic material to construct the bridge.


Detailed Summary:
Sponsor: Queen Mary University of London

Current Primary Outcome: Clinical survival of adhesive bridges [ Time Frame: 5 Years ]

Evaluation of clinical survival: participants will be evaluated according to the modified USPHS criteria. The evaluation criteria will include: retention, framework fracture, veneering fracture, marginal adaptation, recurrent caries and colour match. The examination will be after one to two weeks, after 3, 6, 9, 12 and 18 months, 2, 3, 4 and 5 years. The evaluation will also include the biological complication. Plaque, gingival index, periodontal probing depth and gingival recession will be evaluated around the abutments and compared to a control tooth


Original Primary Outcome: Clinical evaluation of adhesive bridges [ Time Frame: 18 months ]

Evaluation of clinical performance: The patients will be evaluated according to the modified USPHS criteria. The evaluation criteria will include: Retention, Framework fracture, Veneering fracture, marginal adaptation, and recurrent caries, Wear and colour match (Appendix I) and the examination will be after 3, 6, 12 and 18 months. Moreover, the marginal adaptation will be assessed by selecting randomly 10 patients. Then, the assessment will be carried out with the use of Co-ordinate measuring machine after 3, 6, 12 and 18 months


Current Secondary Outcome:

  • Quality of life, aesthetic outcome. [ Time Frame: 18 months ]
    The patients will be requested to fill the OHIP-14 and the VAS questionnaires after one week to two weeks, after 3, 6, 9, 12 and 18 months in order to assess the quality of their lives and their aesthetic outcome after having the bridge.
  • Marginal discrepancy evaluation. [ Time Frame: After cementation ]
    Marginal discrepancy will be evaluated by means of Scannining Electron Microscope (SEM) after cementation.
  • Economic evaluation [ Time Frame: 5 years ]
    Economic evaluation will be run in parallel to the study and will include the overall cost of the two treatments.


Original Secondary Outcome: Quality of life and aesthetic outcome [ Time Frame: 18 months ]

The patients will be requested to fill the OHIP-14 and the VAS questionnaires after 3, 6, 12 and 18 months in order to assess the quality of their lives and their aesthetic outcome after having the bridge. Moreover, three dentists at the same clinic will be asked to fil the VAS dentist questionnaire in order to assess the aesthetic outcome from a professional point of view.


Information By: Queen Mary University of London

Dates:
Date Received: April 27, 2011
Date Started: April 2012
Date Completion: April 2018
Last Updated: February 8, 2012
Last Verified: January 2011