<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03029637</url>
  </required_header>
  <id_info>
    <org_study_id>UW 15-205a</org_study_id>
    <nct_id>NCT03029637</nct_id>
  </id_info>
  <brief_title>No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth</brief_title>
  <official_title>No-preparation Resin Bonded Bridges for the Replacement of Single Missing Teeth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tooth replacement is a significant issue in the World. Such replacement is considered&#xD;
      important by patients to improve aesthetics, function and quality of life. Tooth replacement&#xD;
      is therefore a significant issue. Resin-bonded bridges (RBBs) are conservative and&#xD;
      cost-effective tooth replacement option that involves minimal tooth preparation and are&#xD;
      secured in place with an adhesive cement by bonding to the outer enamel layer of the tooth.&#xD;
      Clinical reports of these prostheses at the University of Hong Kong shows some of the highest&#xD;
      success rate and greatest longevity in the dental literature. However, a problem with this&#xD;
      type of prosthesis in that it still needs some tooth preparation to accommodate the framework&#xD;
      thickness of the bridge. In some patients with tooth wear, this may mean cutting through the&#xD;
      enamel crown down into dentine which will weaken the tooth. In light of the tooth preparation&#xD;
      some patients will refuse this treatment, in particular patients with dental drill phobias.&#xD;
&#xD;
      The aim of this study is to investigate RBBs with tooth preparation and with no tooth&#xD;
      preparation for the replacement of single missing teeth in a randomized controlled trial.&#xD;
      However, a significant consequence of a no preparation RBB will mean that after cementation&#xD;
      the prosthesis will interfere with the patient's bite, making the bridge prosthesis stand&#xD;
      high. This will take time for the patient's original occlusion to re-establish itself by the&#xD;
      movement of the tooth supporting the bridge. Despite the success of &quot;supra-occluding&quot;&#xD;
      restoration has been reported in some studies, currently neither no preparation nor&#xD;
      supraoccluding dental bridges are the standard of care for general dental practitioners and&#xD;
      have not been reported on as a clinical trial in the literature. Most symptoms reported for&#xD;
      supraoccluding restorations were transient and are reversible. The findings of this research&#xD;
      will have significant impact on the teaching and practice for clinical prosthodontics and&#xD;
      patient care worldwide. Patients will have a dental prosthesis that requires no dental&#xD;
      drilling, no local anaesthetic and will have a stronger tooth supporting the bridge that&#xD;
      should have greater longevity. More patients, in particular phobic patients will therefore&#xD;
      seek treatment for tooth replacement with this conservative treatment option.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prosthesis (resin bonded bridge RBB) retention/survival</measure>
    <time_frame>12 months</time_frame>
    <description>Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prosthesis (resin bonded bridge RBB) retention/survival</measure>
    <time_frame>24 months</time_frame>
    <description>Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prosthesis (resin bonded bridge RBB) retention/survival</measure>
    <time_frame>36 months</time_frame>
    <description>Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events that related to no preparation/supra-occluding treatment approach</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken to re-establish the occlusion</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Settling of occlusion is judged by shimstock/occlusal marking paper on teeth adjacent to the prosthesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered outcomes to the Prosthesis (I)</measure>
    <time_frame>36 months</time_frame>
    <description>Subject's satisfaction (in visual analogue scale) on the RBB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered outcomes to the Prosthesis (II)</measure>
    <time_frame>36 months</time_frame>
    <description>Impact of RBB on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered outcomes to the no preparation/supra-occluding treatment approach (I)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Subject's satisfaction (in visual analogue scale) related to the no preparation/supraoccluding treatment approach RBBs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered outcomes to the no preparation/supra-occluding treatment approach (II)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomedical mediators of the no preparation/supra-occluding abutment teeth (I)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of abutment teeth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomedical mediators of the contralateral control teeth (I)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomedical mediators of the no preparation/supra-occluding abutment teeth (II)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of abutment teeth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomedical mediators of the contralateral control teeth (II)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Missing Teeth</condition>
  <arm_group>
    <arm_group_label>No preparation resin bonded bridges</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RBBs with no or minimal preparation of their abutment teeth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine resin bonded bridges</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RBBs with routine tooth preparation of their abutment teeth</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RBBs with no or minimal preparation of their abutment teeth</intervention_name>
    <description>Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth</description>
    <arm_group_label>No preparation resin bonded bridges</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RBBs with routine tooth preparation of their abutment teeth</intervention_name>
    <description>Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth</description>
    <arm_group_label>Routine resin bonded bridges</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 15+ years old&#xD;
&#xD;
          2. A complete bite on the supporting abutment tooth&#xD;
&#xD;
          3. At least one missing upper incisor&#xD;
&#xD;
          4. Controlled dental disease - no active caries or periodontal diseases&#xD;
&#xD;
          5. A minimum of 12 occluding pairs of natural teeth&#xD;
&#xD;
          6. Patients will be available to be clinically reviewed up to 3 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with uncontrolled active tooth decay or periodontal disease (i.e. 5+ mm&#xD;
             probing depth and bleeding on probing).&#xD;
&#xD;
          2. Patients with teeth missing opposite to the planned RBB&#xD;
&#xD;
          3. Abutment tooth mobility of 2 or greater (Millers classification)&#xD;
&#xD;
          4. Patients with debilitating illnesses or complicating medical conditions&#xD;
&#xD;
          5. Heavily restored tooth abutment not suitable for an RBB&#xD;
&#xD;
          6. A supporting abutment with an open bite&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prosthodontics, Faculty of Dentistry, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Michael G Botelho, BDS MSc PhD</last_name>
      <email>Botelho@hku.hk</email>
    </contact>
    <contact_backup>
      <last_name>Walter Y. H. Lam, BDS MDS AdvDipProsth</last_name>
      <email>retlaw@hku.hk</email>
    </contact_backup>
    <investigator>
      <last_name>Michael G Botelho, BDS MSc PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Walter Y. H. Lam, BDS MDS AdvDipProsth</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edward C. M. Lo, BDS MDS PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henry W. K. Luk, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yanqi Yang, BDS, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr Michael G. Botelho</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Resin bonded bridges</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</mesh_term>
    <mesh_term>Anodontia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03029637
org study id: UW 15-205a
nct id: NCT03029637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prosthesis (resin bonded bridge RBB) retention/survival
time frame: 12 months
description: Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
measure: Prosthesis (resin bonded bridge RBB) retention/survival
time frame: 24 months
description: Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
measure: Prosthesis (resin bonded bridge RBB) retention/survival
time frame: 36 months
description: Presence of the prosthesis in patient's mouth (Yes/No) by clinical visual examination
measure: Adverse events that related to no preparation/supra-occluding treatment approach
time frame: Up to 36 months
description: 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
measure: Time taken to re-establish the occlusion
time frame: Up to 36 months
description: Settling of occlusion is judged by shimstock/occlusal marking paper on teeth adjacent to the prosthesis
measure: Patient centered outcomes to the Prosthesis (I)
time frame: 36 months
description: Subject's satisfaction (in visual analogue scale) on the RBB
measure: Patient centered outcomes to the Prosthesis (II)
time frame: 36 months
description: Impact of RBB on subject's oral health related quality of life (Oral Health Impact Profile, OHIP, in Likert scale)
measure: Patient centered outcomes to the no preparation/supra-occluding treatment approach (I)
time frame: Up to 12 months
description: Subject's satisfaction (in visual analogue scale) related to the no preparation/supraoccluding treatment approach RBBs
measure: Patient centered outcomes to the no preparation/supra-occluding treatment approach (II)
time frame: Up to 12 months
description: 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)
measure: Biomedical mediators of the no preparation/supra-occluding abutment teeth (I)
time frame: Up to 36 months
description: Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
measure: Biomedical mediators of the contralateral control teeth (I)
time frame: Up to 36 months
description: Prostaglandin E2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
measure: Biomedical mediators of the no preparation/supra-occluding abutment teeth (II)
time frame: Up to 36 months
description: Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of abutment teeth
measure: Biomedical mediators of the contralateral control teeth (II)
time frame: Up to 36 months
description: Human Interleukin-1 Family 2 level (pg/ul) in the gingival crevicular fluid of contralateral control teeth
arm group label: No preparation resin bonded bridges
arm group type: Experimental
description: RBBs with no or minimal preparation of their abutment teeth
arm group label: Routine resin bonded bridges
arm group type: Active Comparator
description: RBBs with routine tooth preparation of their abutment teeth
intervention type: Device
intervention name: RBBs with no or minimal preparation of their abutment teeth
description: Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth
arm group label: No preparation resin bonded bridges
intervention type: Device
intervention name: RBBs with routine tooth preparation of their abutment teeth
description: Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth
arm group label: Routine resin bonded bridges
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr Michael G. Botelho
investigator title: Clinical Associate Professor
mesh term: Tooth Loss
mesh term: Anodontia
sharing ipd: No