<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/NCT04442763</url>
  </required_header>
  <id_info>
    <org_study_id>Sara89</org_study_id>
    <nct_id>NCT04442763</nct_id>
  </id_info>
  <brief_title>The Effect of Osseodensification on Implant Stability in Posterior Maxilla</brief_title>
  <official_title>Assessment of Dental Implants Stability After Using Osseodensification Method Versus Conventional Drilling in the Posterior Maxilla: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implants will be placed in posterior maxilla using two drilling methods; the&#xD;
      osseodensification technique and standard drilling protocols. Implant stability will be&#xD;
      measured right after implant placement and after 3 months. crestal bone level will be&#xD;
      measured after implant placement and after 3 and 9 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">May 2022</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implant stability</measure>
    <time_frame>baseline- 3 months</time_frame>
    <description>Implant stability will be measured using Osstell (Resonance Frequency Analysis). the measurement unit is Implant stability quotient (ISQ) (range 1-100)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Crestal bone level</measure>
    <time_frame>baseline- 3 months- 9 months</time_frame>
    <description>Digital radiographs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Implant Stability</condition>
  <arm_group>
    <arm_group_label>Densah burs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Osseodensification using Densah burs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard drills</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional drilling using standard drills</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Densah Burs</intervention_name>
    <description>osseodensification method</description>
    <arm_group_label>Densah burs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard drills</intervention_name>
    <description>conventional drilling</description>
    <arm_group_label>Standard drills</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: &gt;18 years;&#xD;
&#xD;
          -  Partially edentulous patients in maxillary posterior area (premolar-molar area)&#xD;
&#xD;
          -  Sufficient ridge height&#xD;
&#xD;
          -  Sufficient ridge width&#xD;
&#xD;
          -  Adequate soft tissue biotype.&#xD;
&#xD;
          -  Patients with adequate inter-arch space for placement of implant prosthetic part.&#xD;
&#xD;
          -  Good oral hygiene&#xD;
&#xD;
          -  Patients who accept to sign an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic diseases that contraindicate implant placement, surgical procedures or may&#xD;
             impair normal healing&#xD;
&#xD;
          -  Patients with habits that may jeopardize the implant longevity as alcoholism and&#xD;
             parafunctional habits.&#xD;
&#xD;
          -  History of radiation therapy to the head and neck&#xD;
&#xD;
          -  Bone augmentation to implant site&#xD;
&#xD;
          -  Heavy smokers (≥ 10 cigarettes per day).&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Psychiatric problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omnia Aboul Dahab</last_name>
    <role>Study Director</role>
    <affiliation>Professor, Faculty of Dentistry, Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sara Abdel Raouf, Assistant Researcher</last_name>
    <phone>+201001271266</phone>
    <phone_ext>+201001271266</phone_ext>
    <email>sara.zagharii@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>April 25, 2022</last_update_submitted>
  <last_update_submitted_qc>April 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sara Amr Abdel Raouf</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Osseodensification</keyword>
  <keyword>Densah burs</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/NCT04442763
org study id: Sara89
nct id: NCT04442763
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Implants will be placed in posterior maxilla using two drilling methods; the
      osseodensification technique and standard drilling protocols. Implant stability will be
      measured right after implant placement and after 3 months. crestal bone level will be
      measured after implant placement and after 3 and 9 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Implant stability
time frame: baseline- 3 months
description: Implant stability will be measured using Osstell (Resonance Frequency Analysis). the measurement unit is Implant stability quotient (ISQ) (range 1-100)
measure: Crestal bone level
time frame: baseline- 3 months- 9 months
description: Digital radiographs
arm group label: Densah burs
arm group type: Experimental
description: Osseodensification using Densah burs
arm group label: Standard drills
arm group type: Active Comparator
description: conventional drilling using standard drills
intervention type: Device
intervention name: Densah Burs
description: osseodensification method
arm group label: Densah burs
intervention type: Device
intervention name: Standard drills
description: conventional drilling
arm group label: Standard drills
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Omnia Aboul Dahab
role: Study Director
affiliation: Professor, Faculty of Dentistry, Cairo University
last name: Sara Abdel Raouf, Assistant Researcher
phone: +201001271266
phone ext: +201001271266
email: sara.zagharii@hotmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sara Amr Abdel Raouf
investigator title: Principle Investigator