<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/NCT03785717</url>
  </required_header>
  <id_info>
    <org_study_id>PCI2015-8351</org_study_id>
    <nct_id>NCT03785717</nct_id>
  </id_info>
  <brief_title>Horizontal Ridge Augmentation in Mandible Usign ROG + ESWT</brief_title>
  <official_title>Horizontal Guide Bone Regeneration With or Without Shock Waves: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad El Bosque, Bogotá</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gloria Lafaurie</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carlos Leal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad El Bosque, Bogotá</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge&#xD;
      deficiencies, allowing to restore such defects in order to place bone-integrated dental&#xD;
      implants. A few reports exist in the literature about the augmentation of mandibular&#xD;
      horizontal ridge defects before implant placement. Published studies show a large variability&#xD;
      of reported results regarding horizontal bone augmentation. This can be due to the use of&#xD;
      different types of membranes and bone graft materials or a combination thereof. Likewise, an&#xD;
      important percentage of graft reabsorption is reported. Although this technique is very much&#xD;
      used, an important number of cases must be re-treated or require placing bone graft during&#xD;
      implant installation surgery. Techniques are required in order to improve vascularization of&#xD;
      the grafts during GBR technique with the aim to improve their clinical success. Recent&#xD;
      studies show great interest on the application of shock waves in oral diseases associated to&#xD;
      infection and bone loss. The shock waves are acoustic waves that have effects on human&#xD;
      biological tissues, stimulating the neo-angiogenesis and the development of a hyper&#xD;
      cellularity, showing repairing characteristics on tissues, and starting regenerative&#xD;
      processes as a result of metabolism improvement and the increase of local circulation. The&#xD;
      extra corporeal shock waves can activate the osteoblasts and their precursors and they have&#xD;
      been widely used in orthopaedics for repairing bone fractures. Several clinical studies have&#xD;
      shown the effectiveness and safety of shock wave therapy in myocardial revascularization,&#xD;
      lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated&#xD;
      injuries of soft tissues. No clinical studies exist that assess its effect on guided bone&#xD;
      regeneration. The evidence related to the positive effects of the use of shock waves on bone&#xD;
      regeneration suggests this treatment as a novelty and a promising therapy that combined with&#xD;
      the GBR technique for the treatment of horizontal defects could have an important impact on&#xD;
      the potentialization of its clinical effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General Objective:&#xD;
&#xD;
      Assessing the efficacy of horizontal augmentation and percentage of reabsorption of bone&#xD;
      graft material in the technique of guided bone regeneration (GBR), combined with the shock&#xD;
      wave therapy (SWT) in the horizontal bone reconstruction of mandibular alveolar ridges.&#xD;
&#xD;
      Type of study:&#xD;
&#xD;
      Triple blind randomized clinical trial&#xD;
&#xD;
      Population and sample:&#xD;
&#xD;
      Twenty six patients of university and private clinical practice, who require augmentation of&#xD;
      horizontal ridge in the mandible for back placing of an implant, and their compliance with&#xD;
      inclusion and exclusion criteria, will be assessed.&#xD;
&#xD;
      Type of analysis:&#xD;
&#xD;
      Central trend and dispersion (medium and standard deviation) measurements will be obtained.&#xD;
      Type of data distribution using Shapiro Wilk.&#xD;
&#xD;
      t-student test between no related groups for assessing bone augmentation. t-paired test&#xD;
      between related groups for assessing pre and post treatment within the same group.&#xD;
&#xD;
      t test for proportion difference, in order to assess the percentage of reabsorption of bone&#xD;
      graft, bone density, bone quality, within a same group.&#xD;
&#xD;
      Fisher, group comparison.&#xD;
&#xD;
      A multiple linear regression model will be developed in order to establish if the difference&#xD;
      among groups is influenced by the initial width of the ridge and the thickness of the soft&#xD;
      tissue.&#xD;
&#xD;
      In case of not following a normal distribution, no parametrical tests for related and no&#xD;
      related groups and logistic regression, will be used.&#xD;
&#xD;
      The frequencies of adverse effects in each group will be obtained, and compared to the Chi2&#xD;
      test or the Fisher exact test.&#xD;
&#xD;
      All the analyses will be made with significance level of 5% (p&lt; 0.05).&#xD;
&#xD;
      Effect measurements: Relative Risk (RR), Attributable Risk Reduction (ARR), and Necessary&#xD;
      Number to be Treated (NNT). The augmentation of horizontal volume that allows the&#xD;
      installation of a ≥4.1 mm implant will be taken as cutting point reference of clinical&#xD;
      success.&#xD;
&#xD;
      Expected Results:&#xD;
&#xD;
        -  Establishing the effect of the shock wave therapy, in combination with guided bone&#xD;
           regeneration, on the improvement of bone augmentation and the decrease of bone graft&#xD;
           reabsorption.&#xD;
&#xD;
        -  Establishing the effect of shock wave therapy, in combination with guided bone&#xD;
           regeneration, on the improvement of bone quality and density, as well as on decreasing&#xD;
           the adverse effects.&#xD;
&#xD;
        -  Acquiring new knowledge in the area of bone reconstruction.&#xD;
&#xD;
        -  Presentation of results in local and international congresses.&#xD;
&#xD;
        -  Formation of human resource; mastery graduation paper on Dentistry Science Master.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.</measure>
    <time_frame>Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.</time_frame>
    <description>Using specialized software in dental implantology, measurements are taken in the tomographies taken of each volunteer patient, in order to determine the increase in bone volume in the intervention, and its reabsorption after the healing process.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Bone Regeneration</condition>
  <arm_group>
    <arm_group_label>ROG only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cancellous (1-2 mm) &amp; cortical (250-1000 mm) bone allograft and pericardium membrane without extracorporeal shockwave therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROG &amp; ESWT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cancellous 1-2mm &amp; cortical 250-1000mm Bonegrafts and membrane with extracorporeal shockwave therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ROG</intervention_name>
    <description>Bone width augmentation using bone grafting and membrane non cross linking.</description>
    <arm_group_label>ROG &amp; ESWT</arm_group_label>
    <arm_group_label>ROG only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ROG &amp; ESWT</intervention_name>
    <description>Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).</description>
    <arm_group_label>ROG &amp; ESWT</arm_group_label>
    <arm_group_label>ROG only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who agree to participate in the study and sign informed consent&#xD;
&#xD;
          -  Partial mandibular edentulism requiring at least two teeth to be replaced with&#xD;
             osseointegrated implants&#xD;
&#xD;
          -  Patient with alveolar ridge thickness of ≤4mm, evaluated by CBCT&#xD;
&#xD;
          -  Vertical bone availability of 9mm to anatomical structure such as a chin or dental&#xD;
             canal that allows a short implant placement of 8mm at the end of the study.&#xD;
&#xD;
          -  Extractions performed ≥ 6 months&#xD;
&#xD;
          -  Elderly patients between 35 and 65 years old&#xD;
&#xD;
          -  Patients without current disease or with chronic pathologies in medical control that&#xD;
             does not affect the healing processes such as: controlled hypertension, controlled&#xD;
             hypothyroidism, controlled hypercholesterolemia&#xD;
&#xD;
          -  Evaluated by anamnesis and laboratory tests that rule out processes of&#xD;
             immunosuppression, glycemia and coagulation disorders hypercholesterolemia&#xD;
&#xD;
          -  No smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Immunosuppressive drugs&#xD;
&#xD;
          -  Anti-coagulated or with dual anti-platelet aggregation&#xD;
&#xD;
          -  Therapy with bisphosphonates&#xD;
&#xD;
          -  Hormone replacement therapy&#xD;
&#xD;
          -  Patient with a history of radiotherapy of the head and neck&#xD;
&#xD;
          -  Pregnant women or nursing&#xD;
&#xD;
          -  Permanent consumption of NSAIDs and corticosteroids&#xD;
&#xD;
          -  Prolonged antibiotic therapy in the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yamil Lesmes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad El Bosque</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yamil Lesmes</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>March 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad El Bosque, Bogotá</investigator_affiliation>
    <investigator_full_name>Yamil Lesmes</investigator_full_name>
    <investigator_title>DDS, MSc candidate</investigator_title>
  </responsible_party>
  <keyword>shock wave therapy (SWT or ESWT)</keyword>
  <keyword>Guided bone regeneration (GBR)</keyword>
  <keyword>horizontal ridge augmentation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03785717
org study id: PCI2015-8351
nct id: NCT03785717
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Guided bone regeneration (GBR) has been the most frequently used option to treat bone ridge
      deficiencies, allowing to restore such defects in order to place bone-integrated dental
      implants. A few reports exist in the literature about the augmentation of mandibular
      horizontal ridge defects before implant placement. Published studies show a large variability
      of reported results regarding horizontal bone augmentation. This can be due to the use of
      different types of membranes and bone graft materials or a combination thereof. Likewise, an
      important percentage of graft reabsorption is reported. Although this technique is very much
      used, an important number of cases must be re-treated or require placing bone graft during
      implant installation surgery. Techniques are required in order to improve vascularization of
      the grafts during GBR technique with the aim to improve their clinical success. Recent
      studies show great interest on the application of shock waves in oral diseases associated to
      infection and bone loss. The shock waves are acoustic waves that have effects on human
      biological tissues, stimulating the neo-angiogenesis and the development of a hyper
      cellularity, showing repairing characteristics on tissues, and starting regenerative
      processes as a result of metabolism improvement and the increase of local circulation. The
      extra corporeal shock waves can activate the osteoblasts and their precursors and they have
      been widely used in orthopaedics for repairing bone fractures. Several clinical studies have
      shown the effectiveness and safety of shock wave therapy in myocardial revascularization,
      lithotripsy, cellulitis, volar fasciitis, osteonecrosis, bone fractures, and complicated
      injuries of soft tissues. No clinical studies exist that assess its effect on guided bone
      regeneration. The evidence related to the positive effects of the use of shock waves on bone
      regeneration suggests this treatment as a novelty and a promising therapy that combined with
      the GBR technique for the treatment of horizontal defects could have an important impact on
      the potentialization of its clinical effectiveness.
General Objective:

      Assessing the efficacy of horizontal augmentation and percentage of reabsorption of bone
      graft material in the technique of guided bone regeneration (GBR), combined with the shock
      wave therapy (SWT) in the horizontal bone reconstruction of mandibular alveolar ridges.

      Type of study:

      Triple blind randomized clinical trial

      Population and sample:

      Twenty six patients of university and private clinical practice, who require augmentation of
      horizontal ridge in the mandible for back placing of an implant, and their compliance with
      inclusion and exclusion criteria, will be assessed.

      Type of analysis:

      Central trend and dispersion (medium and standard deviation) measurements will be obtained.
      Type of data distribution using Shapiro Wilk.

      t-student test between no related groups for assessing bone augmentation. t-paired test
      between related groups for assessing pre and post treatment within the same group.

      t test for proportion difference, in order to assess the percentage of reabsorption of bone
      graft, bone density, bone quality, within a same group.

      Fisher, group comparison.

      A multiple linear regression model will be developed in order to establish if the difference
      among groups is influenced by the initial width of the ridge and the thickness of the soft
      tissue.

      In case of not following a normal distribution, no parametrical tests for related and no
      related groups and logistic regression, will be used.

      The frequencies of adverse effects in each group will be obtained, and compared to the Chi2
      test or the Fisher exact test.

      All the analyses will be made with significance level of 5% (p< 0.05).

      Effect measurements: Relative Risk (RR), Attributable Risk Reduction (ARR), and Necessary
      Number to be Treated (NNT). The augmentation of horizontal volume that allows the
      installation of a ≥4.1 mm implant will be taken as cutting point reference of clinical
      success.

      Expected Results:

        -  Establishing the effect of the shock wave therapy, in combination with guided bone
           regeneration, on the improvement of bone augmentation and the decrease of bone graft
           reabsorption.

        -  Establishing the effect of shock wave therapy, in combination with guided bone
           regeneration, on the improvement of bone quality and density, as well as on decreasing
           the adverse effects.

        -  Acquiring new knowledge in the area of bone reconstruction.

        -  Presentation of results in local and international congresses.

        -  Formation of human resource; mastery graduation paper on Dentistry Science Master.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Bone width (in mm), as assessed using (CBCT) on a partially edentulous patients after ROG+ESWT.
time frame: Patients will be assessed prior the ROG, two weeks after ROG, and 6 months after ROG in order to determinate actual situation, the situation after the ROG placement and the reabsorption of ROG material.
description: Using specialized software in dental implantology, measurements are taken in the tomographies taken of each volunteer patient, in order to determine the increase in bone volume in the intervention, and its reabsorption after the healing process.
arm group label: ROG only
arm group type: Active Comparator
description: cancellous (1-2 mm) & cortical (250-1000 mm) bone allograft and pericardium membrane without extracorporeal shockwave therapy
arm group label: ROG & ESWT
arm group type: Active Comparator
description: cancellous 1-2mm & cortical 250-1000mm Bonegrafts and membrane with extracorporeal shockwave therapy
intervention type: Procedure
intervention name: ROG
description: Bone width augmentation using bone grafting and membrane non cross linking.
arm group label: ROG & ESWT
arm group label: ROG only
intervention type: Procedure
intervention name: ROG & ESWT
description: Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).
arm group label: ROG & ESWT
arm group label: ROG only
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yamil Lesmes
role: Principal Investigator
affiliation: Universidad El Bosque
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Universidad El Bosque, Bogotá
investigator full name: Yamil Lesmes
investigator title: DDS, MSc candidate
sharing ipd: Undecided