<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/NCT03307798</url>
  </required_header>
  <id_info>
    <org_study_id>201612189RIND</org_study_id>
    <nct_id>NCT03307798</nct_id>
  </id_info>
  <brief_title>Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery</brief_title>
  <acronym>SBTP</acronym>
  <official_title>Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bone quality is one of the major factors influencing the dental implant survival rate. Bone&#xD;
      quality is believed to have effects on initial implant stability and success of&#xD;
      osseointegration. Different implant designs and surgical protocols were developed for&#xD;
      improving the survival rate in different bone quality. Although bone quality can be partly&#xD;
      diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality&#xD;
      with tactile sensation when they drill the bone. However, variations in evaluation of bone&#xD;
      density maybe exist among different surgeons. For less experienced dentists, it is difficult&#xD;
      to diagnose bone quality with tactile sensation in the beginning. This purpose of this study&#xD;
      is to evaluate a training protocol in using tactile sensation to classify bone quality during&#xD;
      implant surgery. Saw bones of variant densities are used as training materials. The outcomes&#xD;
      before and after training will be compared. The effect of training frequency before surgery&#xD;
      will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-five dentists will be enrolled into the study. Tests will be performed using visual&#xD;
      analog scale to score bone quality of test blocks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change on visual analog scale (VAS) score of each test block</measure>
    <time_frame>1st time point: test before training &amp; test immediately after training; 2nd time point: 1 week after 1st time point (test after 1 wk); 3rd time point: 1 month after 2nd time point (test after 1month)</time_frame>
    <description>Each VAS score performed on the specific test block will be compared between different time point.</description>
  </primary_outcome>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Surgery</condition>
  <condition>Training Tactile Sensation</condition>
  <condition>Diagnosis of Bone Quality</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Dentists in Taiwan&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Certified dentist with implant surgery experience less than 10 implants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age exceed the limits&#xD;
&#xD;
          -  Implant surgery experience more or equal to 10 implants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tong-Mei Wang Wang, DDS, MS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tong-Mei Wang, DDS, MS, PhD</last_name>
    <phone>886223123456</phone>
    <phone_ext>66864</phone_ext>
    <email>tongmeiwang@ntu.edu.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Li-Deh Lin, DDS, PhD</last_name>
    <phone>886223123456</phone>
    <phone_ext>66864</phone_ext>
    <email>lidehlin@ntu.edu.tw</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tong-Mei Wang, PHD</last_name>
      <phone>886223123456</phone>
      <phone_ext>66864</phone_ext>
      <email>tongmeiwang@ntu.edu.tw</email>
    </contact>
    <contact_backup>
      <last_name>Li-Deh Lin, DDS, PhD</last_name>
      <phone>886223123456</phone>
      <phone_ext>66864</phone_ext>
      <email>lidehlin@ntu.edu.tw</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Friberg B, Sennerby L, Meredith N, Lekholm U. A comparison between cutting torque and resonance frequency measurements of maxillary implants. A 20-month clinical study. Int J Oral Maxillofac Surg. 1999 Aug;28(4):297-303.</citation>
    <PMID>10416900</PMID>
  </reference>
  <reference>
    <citation>Johansson P, Strid KG. Assessment of bone quality from cutting resistance during implant surgery. Internatioanl Journal of Oral &amp; Maxillofacial implants 9:279-288, 1994</citation>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dental implant,bone quality,tactile sensation</keyword>
  <!-- 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/NCT03307798
org study id: 201612189RIND
nct id: NCT03307798
lead sponsor: 
has dmc: No
Bone quality is one of the major factors influencing the dental implant survival rate. Bone
      quality is believed to have effects on initial implant stability and success of
      osseointegration. Different implant designs and surgical protocols were developed for
      improving the survival rate in different bone quality. Although bone quality can be partly
      diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality
      with tactile sensation when they drill the bone. However, variations in evaluation of bone
      density maybe exist among different surgeons. For less experienced dentists, it is difficult
      to diagnose bone quality with tactile sensation in the beginning. This purpose of this study
      is to evaluate a training protocol in using tactile sensation to classify bone quality during
      implant surgery. Saw bones of variant densities are used as training materials. The outcomes
      before and after training will be compared. The effect of training frequency before surgery
      will also be evaluated.
Twenty-five dentists will be enrolled into the study. Tests will be performed using visual
      analog scale to score bone quality of test blocks.
observational model: Other
time perspective: Prospective
measure: Change on visual analog scale (VAS) score of each test block
time frame: 1st time point: test before training & test immediately after training; 2nd time point: 1 week after 1st time point (test after 1 wk); 3rd time point: 1 month after 2nd time point (test after 1month)
description: Each VAS score performed on the specific test block will be compared between different time point.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 26 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tong-Mei Wang Wang, DDS, MS, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Tong-Mei Wang, DDS, MS, PhD
phone: 886223123456
phone ext: 66864
email: tongmeiwang@ntu.edu.tw
last name: Li-Deh Lin, DDS, PhD
phone: 886223123456
phone ext: 66864
email: lidehlin@ntu.edu.tw
facility: 
status: Recruiting
contact: 
contact backup: 
country: Taiwan
citation: Friberg B, Sennerby L, Meredith N, Lekholm U. A comparison between cutting torque and resonance frequency measurements of maxillary implants. A 20-month clinical study. Int J Oral Maxillofac Surg. 1999 Aug;28(4):297-303.
PMID: 10416900
citation: Johansson P, Strid KG. Assessment of bone quality from cutting resistance during implant surgery. Internatioanl Journal of Oral & Maxillofacial implants 9:279-288, 1994
responsible party type: Sponsor