Clinical Trial: No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth

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

Official Title: No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth

Brief Summary:

Tooth replacement is a significant issue in the World. Such replacement is considered important by patients to improve aesthetics, function and quality of life. Tooth replacement is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and cost-effective tooth replacement option that involves minimal tooth preparation and are secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth. Clinical reports of these prostheses at the University of Hong Kong shows some of the highest success rate and greatest longevity in the dental literature. However, a problem with this type of prosthesis in that it still needs some tooth preparation to accommodate the framework thickness of the bridge. In some patients with tooth wear, this may mean cutting through the enamel crown down into dentine which will weaken the tooth. In light of the tooth preparation some patients will refuse this treatment, in particular patients with dental drill phobias.

The aim of this study is to investigate RBBs with tooth preparation and with no tooth preparation for the replacement of single missing teeth in a randomized controlled trial. However, a significant consequence of a no preparation RBB will mean that after cementation the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand high. This will take time for the patient's original occlusion to re-establish itself by the movement of the tooth supporting the bridge. Despite the success of "supra-occluding" restoration has been reported in some studies, currently neither no preparation nor supraoccluding dental bridges are the standard of care for general dental practitioners and have not been reported on as a clinical trial in the literature. Most symptoms reported for supraoccluding restorations were transient and are reversible. The findings of this resea

Detailed Summary:
Sponsor: The University of Hong Kong

Current Primary Outcome:

  • Prosthesis (resin bonded bridge RBB) retention/survival [ Time Frame: 12 months ]
    Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
  • Prosthesis (resin bonded bridge RBB) retention/survival [ Time Frame: 24 months ]
    Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
  • Prosthesis (resin bonded bridge RBB) retention/survival [ Time Frame: 36 months ]
    Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse events that related to no preparation/supra-occluding treatment approach [ Time Frame: Up to 36 months ]
    Presence of clinical signs and symptoms or not (Yes/No) including but not limited to impact on patient's speech as well as thermal sensitivity, increased tooth mobility, periodontal/pulpal health of the abutment teeth
  • Time taken to re-establish the occlusion [ Time Frame: Up to 36 months ]
    Settling of occlusion is judged by shimstock/occlusal marking paper on teeth adjacent to the prosthesis
  • Patient centered outcomes to the Prosthesis (I) [ Time Frame: 36 months ]
    Subject's satisfaction (in visual analogue scale) on the RBB
  • Patient centered outcomes to the Prosthesis (II) [ Time Frame: 36 months ]
    Impact of RBB on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)
  • Patient centered outcomes to the no preparation/supra-occluding treatment approach (I) [ Time Frame: Up to 12 months ]
    Subject's satisfaction (in visual analogue scale) related to the no preparation/supraoccluding treatment approach RBBs
  • Patient centered outcomes to the no preparation/supra-occluding treatment approach (II) [ Time Frame: Up to 12 months ]
    Impact of the no preparation/supraoccluding treatment approach on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)
  • Biomedical mediators of the no preparation/supra-occluding abutment teeth (I) [ Time Frame: Up to 36 months ]
    Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
  • Biomedical mediators of the contralateral control teeth (I) [ Time Frame: Up to 36 months ]
    Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
  • Biomedical mediators of the no preparation/supra-occluding abutment teeth (II) [ Time Frame: Up to 36 months ]
    Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
  • Biomedical mediators of the contralateral control teeth (II) [ Time Frame: Up to 36 months ]
    Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth


Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: December 30, 2016
Date Started: June 2017
Date Completion: December 2020
Last Updated: January 19, 2017
Last Verified: January 2017