<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/NCT03250949</url>
  </required_header>
  <id_info>
    <org_study_id>Randomized Controlled Trial</org_study_id>
    <nct_id>NCT03250949</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol</brief_title>
  <acronym>RCT</acronym>
  <official_title>Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following Over-drilling Compared To Conventional-Drilling Protocol: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azhar ALI ELSAYED SELEEM</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following&#xD;
      Over-drilling Compared To Conventional-Drilling Protocol&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Statement of the problem:&#xD;
&#xD;
      peri-implant bone is affected by excessive mechanical stress, the mechanism of bone formation&#xD;
      is reduced and the bone resorption is increased, leading to MBL. Isidor F. 2006, Warreth A,&#xD;
      009 A drilling sequence using a drill that is smaller than the implant diameter has been&#xD;
      applied as a way to obtain enough initial stability.Bilhan H,2010 However, the implant can be&#xD;
      extremely compressed or exceed the torque, which can be higher than the elastic limit of bone&#xD;
      when a drill that is smaller than the implant diameter is used. This may affect the bone&#xD;
      surrounding the implant and may also lead to a micro fracture.&#xD;
&#xD;
      Frost mentioned that alveolar bone density is changed by micro deformation due to&#xD;
      modification of the physical condition. Bone resorption and fibrous tissue production&#xD;
      progress if the micro deformation rate is higher than 3,000 micro strain (με). Also,&#xD;
      continuous bone replacement occurs while woven bone appears. Wolff J.1986 Bone tissue adapts&#xD;
      to the change of stress while minimizing its weight and transforming its structure. Frost&#xD;
      HM,1989 The bone formation mechanism is inhibited and the bone resorption mechanism is&#xD;
      enhanced if excessive mechanical stress is applied to alveolar bone during implantation,&#xD;
      resulting in the progression of marginal bone loss (MBL). Isidor F.2006 , Warreth A,2009-&#xD;
&#xD;
      Rationale for carrying out the trial:&#xD;
&#xD;
      Success and survival rate of an implant are directly associated with primary stability.&#xD;
      Friberg B,et al 1991 Primary stability is achieved with initial rigid fixation of implants&#xD;
      during the surgery and considered necessary for a successful osseointegration. Sennerby L,et&#xD;
      al 1992, Rodrigo D,et al 2010 There are two different processes of bone formation at implant&#xD;
      sites; contact and distance osteogenesis. Contact osteogenesis infers new bone formation in&#xD;
      direct contact with the implant surface. Distance osteogenesis is the new bone formation on&#xD;
      the surfaces of the parent bone and occurs when primary stability is absent at implant site.&#xD;
      Davies JE.et al 2003, Sivolella S,et al2012&#xD;
&#xD;
      When there is a gap between the implant surface and bone, a clot will fill the space and will&#xD;
      be replaced by a provisional connective matrix that will act as scaffold for formation of&#xD;
      woven bone. Berglundh T,et al,2003 , Rossi F,2012 Our study will evaluate the effect of&#xD;
      oversized drilling on implant success and secondary stability&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implant stability</measure>
    <time_frame>first 3 months</time_frame>
    <description>Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Crestal bone level</measure>
    <time_frame>from 3 to 6 month</time_frame>
    <description>by Digital radiography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Crestal Bone Resorption</condition>
  <condition>Implant Primary Stability</condition>
  <condition>Implant Osseointegration</condition>
  <arm_group>
    <arm_group_label>Conventional-Drilling Tight Fit (Control) group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Over-drilling Loose Fit (Test) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>implant site over drilling protocol</intervention_name>
    <description>Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.&#xD;
osteotomy site of the implant is wider by 0.2mm than the implant diameter</description>
    <arm_group_label>Over-drilling Loose Fit (Test) group</arm_group_label>
    <other_name>NEO biotech implant system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have at least one missing tooth in the upper maxillary arch.&#xD;
&#xD;
          -  Patients with healthy systemic condition.(Brightman. 1994)&#xD;
&#xD;
          -  Patients aged from 20 to 60 years old.&#xD;
&#xD;
          -  Good oral hygiene.(Wiesner et al. 2010)&#xD;
&#xD;
          -  Accepts 9 months follow-up period (cooperative patients)&#xD;
&#xD;
          -  Patient provides an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with signs of acute infection related to the area of interest.&#xD;
&#xD;
          -  Patients with habits that may jeopardize the implant longevity and affect the results&#xD;
             of the study such as parafunctional habits (Lobbezoo et al. 2006).&#xD;
&#xD;
          -  Current and former smokers (Lambert, Morris, and Ochi 2000)&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Azhar ALI ELSAYED SELEEM</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
  </condition_browse>
  <!-- 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/NCT03250949
org study id: Randomized Controlled Trial
nct id: NCT03250949
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical Evaluation Of Dental Implants Stability Placed In Healed Bony Sites Following
      Over-drilling Compared To Conventional-Drilling Protocol
- Statement of the problem:

      peri-implant bone is affected by excessive mechanical stress, the mechanism of bone formation
      is reduced and the bone resorption is increased, leading to MBL. Isidor F. 2006, Warreth A,
      009 A drilling sequence using a drill that is smaller than the implant diameter has been
      applied as a way to obtain enough initial stability.Bilhan H,2010 However, the implant can be
      extremely compressed or exceed the torque, which can be higher than the elastic limit of bone
      when a drill that is smaller than the implant diameter is used. This may affect the bone
      surrounding the implant and may also lead to a micro fracture.

      Frost mentioned that alveolar bone density is changed by micro deformation due to
      modification of the physical condition. Bone resorption and fibrous tissue production
      progress if the micro deformation rate is higher than 3,000 micro strain (με). Also,
      continuous bone replacement occurs while woven bone appears. Wolff J.1986 Bone tissue adapts
      to the change of stress while minimizing its weight and transforming its structure. Frost
      HM,1989 The bone formation mechanism is inhibited and the bone resorption mechanism is
      enhanced if excessive mechanical stress is applied to alveolar bone during implantation,
      resulting in the progression of marginal bone loss (MBL). Isidor F.2006 , Warreth A,2009-

      Rationale for carrying out the trial:

      Success and survival rate of an implant are directly associated with primary stability.
      Friberg B,et al 1991 Primary stability is achieved with initial rigid fixation of implants
      during the surgery and considered necessary for a successful osseointegration. Sennerby L,et
      al 1992, Rodrigo D,et al 2010 There are two different processes of bone formation at implant
      sites; contact and distance osteogenesis. Contact osteogenesis infers new bone formation in
      direct contact with the implant surface. Distance osteogenesis is the new bone formation on
      the surfaces of the parent bone and occurs when primary stability is absent at implant site.
      Davies JE.et al 2003, Sivolella S,et al2012

      When there is a gap between the implant surface and bone, a clot will fill the space and will
      be replaced by a provisional connective matrix that will act as scaffold for formation of
      woven bone. Berglundh T,et al,2003 , Rossi F,2012 Our study will evaluate the effect of
      oversized drilling on implant success and secondary stability
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: implant stability
time frame: first 3 months
description: Resonance frequency analysis (RFA) OSSTELL (Osstell Resonance frequency analysis (RFA) (Osstell
measure: Crestal bone level
time frame: from 3 to 6 month
description: by Digital radiography
arm group label: Conventional-Drilling Tight Fit (Control) group
arm group type: No Intervention
description: osteotomy will be achieved with no. 6 round , then widened , using a drill 1 mm larger than the final drill provided by the manufacturer. the final size of the control osteotomies were same diameter of the implant.
arm group label: Over-drilling Loose Fit (Test) group
arm group type: Experimental
description: Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.
intervention type: Procedure
intervention name: implant site over drilling protocol
description: Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.
osteotomy site of the implant is wider by 0.2mm than the implant diameter
arm group label: Over-drilling Loose Fit (Test) group
other name: NEO biotech implant system
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Azhar ALI ELSAYED SELEEM
investigator title: doctor
mesh term: Bone Resorption