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

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ClinicalTrials.gov Identifier: NCT03029637
Recruitment Status : Not yet recruiting
First Posted : January 24, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Michael G. Botelho, The University of Hong Kong

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 research will have significant impact on the teaching and practice for clinical prosthodontics and patient care worldwide. Patients will have a dental prosthesis that requires no dental drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that should have greater longevity. More patients, in particular phobic patients will therefore seek treatment for tooth replacement with this conservative treatment option.


Condition or disease Intervention/treatment Phase
Missing Teeth Device: RBBs with no or minimal preparation of their abutment teeth Device: RBBs with routine tooth preparation of their abutment teeth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: No preparation resin bonded bridges
RBBs with no or minimal preparation of their abutment teeth
Device: RBBs with no or minimal preparation of their abutment teeth
Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth

Active Comparator: Routine resin bonded bridges
RBBs with routine tooth preparation of their abutment teeth
Device: RBBs with routine tooth preparation of their abutment teeth
Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Patient centered outcomes to the Prosthesis (I) [ Time Frame: 36 months ]
    Subject's satisfaction (in visual analogue scale) on the RBB

  4. 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)

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 15+ years old
  2. A complete bite on the supporting abutment tooth
  3. At least one missing upper incisor
  4. Controlled dental disease - no active caries or periodontal diseases
  5. A minimum of 12 occluding pairs of natural teeth
  6. Patients will be available to be clinically reviewed up to 3 years

Exclusion Criteria:

  1. Patients with uncontrolled active tooth decay or periodontal disease (i.e. 5+ mm probing depth and bleeding on probing).
  2. Patients with teeth missing opposite to the planned RBB
  3. Abutment tooth mobility of 2 or greater (Millers classification)
  4. Patients with debilitating illnesses or complicating medical conditions
  5. Heavily restored tooth abutment not suitable for an RBB
  6. A supporting abutment with an open bite

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): NCT03029637


Locations
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China
Prosthodontics, Faculty of Dentistry, The University of Hong Kong Not yet recruiting
Hong Kong, China
Contact: Michael G Botelho, BDS MSc PhD       Botelho@hku.hk   
Contact: Walter Y. H. Lam, BDS MDS AdvDipProsth       retlaw@hku.hk   
Principal Investigator: Michael G Botelho, BDS MSc PhD         
Sub-Investigator: Walter Y. H. Lam, BDS MDS AdvDipProsth         
Sub-Investigator: Edward C. M. Lo, BDS MDS PhD         
Sub-Investigator: Henry W. K. Luk, PhD         
Sub-Investigator: Yanqi Yang, BDS, PhD         
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Dr Michael G. Botelho, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03029637     History of Changes
Other Study ID Numbers: UW 15-205a
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
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 Dr Michael G. Botelho, The University of Hong Kong:
Resin bonded bridges
Randomized controlled trial

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities