<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/NCT03302143</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20120264H</org_study_id>
    <nct_id>NCT03302143</nct_id>
  </id_info>
  <brief_title>Radiographic and the Esthetic Outcome of Two Different Bone Grafting Techniques in Early Implant Placement</brief_title>
  <official_title>A Comparative, Randomized, Prospective, Clinical Study to Evaluate the Facial Bone and Esthetic Outcome of Buccal Augmentation Bone Grafting Techniques in Early (Type 2) Implant Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total of 48 subjects were randomly assigned to treatment groups:&#xD;
&#xD;
      UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan&#xD;
&#xD;
      Patients require a maxillary non-molar extraction site that is planned to be replaced by a&#xD;
      dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) &amp; Regular&#xD;
      (4.1mm) Crossfit implants in all available lengths.&#xD;
&#xD;
      Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM&#xD;
      (control/standard) for contour augmentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This comparative, randomized, prospective clinical study is designed to compare clinical&#xD;
      outcomes and facial bone height and thickness of two different bone grafting techniques after&#xD;
      augmentation in (Type 2) early implant placement.&#xD;
&#xD;
      Human subjects who could potentially qualify with the said inclusion criteria will be&#xD;
      evaluated and screened. 24 human subjects who qualify for the procedure will have a thorough&#xD;
      evaluation performed after obtaining consent from the patient. All subjects will require&#xD;
      extraction of maxillary teeth (incisors, canines, premolars), followed by early implant&#xD;
      placement of the missing teeth after 4 to 8 weeks extraction.&#xD;
&#xD;
      There will be two subject groups in this study in which the 24 human subjects in will&#xD;
      randomly be placed by selecting the number &quot;1&quot; or &quot;2&quot; from a hat. 24 human subjects will be&#xD;
      divided into two groups including 12 subjects using control group design and 12 subjects&#xD;
      using test group design. 12 subjects will be placed randomly into Group 1 and will undergo&#xD;
      the flapless extraction and early implant placement with GBR procedure using the control&#xD;
      group design. 12 subjects will be placed randomly into Group 2 and will undergo the flapless&#xD;
      extraction and early implant placement with GBR procedure using the test group design.&#xD;
&#xD;
      During the implant placement visit after 4 to 8 weeks of extraction, patient will be asked to&#xD;
      select a number from a hat. If the number showed &quot;1&quot; as a control group, autograft , BBM and&#xD;
      collagen membrane will be used as GBR materials after implant placement. If the number showed&#xD;
      &quot;2&quot; as a test group, FDBA and collagen membrane will be used as GBR materials after implant&#xD;
      placement.&#xD;
&#xD;
      Extraction sites will include maxillary teeth (11,12,13,14,15,21,22,23,24,25 according to&#xD;
      FDI) having intact adjacent teeth. Implants placed for this study will have a SLActive&#xD;
      surface, bone level design, Straumann NC 3.3mm or RC 4.1mm in diameter at all available&#xD;
      implant lengths.&#xD;
&#xD;
      Control group: early implant placement with autograft plus BBM (Bio-Oss, Geistlich Pharm AG,&#xD;
      Wolhausen, Switzerland) plus two layers of collagen membrane (BioGide®).&#xD;
&#xD;
      Test group: early implant placement with FDBA (Straumann Allograft GC®) plus two layers of&#xD;
      collagen membrane (BioGide®).&#xD;
&#xD;
      These procedures will follow the guidelines as described by Buser et al. (2008). Implant&#xD;
      placements will follow standard protocols utilizing tapping and placement with the hand&#xD;
      ratchet.&#xD;
&#xD;
      A CBCT radiograph will be made during the screening visit to determine eligibility for the&#xD;
      study and immediately following implant placement with GBR procedure to provide facial bone&#xD;
      height and thickness measurements. The second CBCT procedure is not typically a standard of&#xD;
      care procedure. After 12 months post loading healing time, the patient will receive another&#xD;
      CBCT. This CBCT is also not a standard of care procedure but can accurately assess the amount&#xD;
      of facial bone height and thickness maintained during the follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2013</start_date>
  <completion_date type="Actual">May 15, 2016</completion_date>
  <primary_completion_date type="Actual">May 15, 2016</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>
    <intervention_model_description>A comparative, randomized, prospective, clinical study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Facial bone thickness</measure>
    <time_frame>Measured at 1 year post-loading</time_frame>
    <description>Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in facial bone thickness</measure>
    <time_frame>Between implant placement and 1 year post-loading</time_frame>
    <description>Change in facial bone thickness between implant placement and 1 year post-loading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mPI measurement</measure>
    <time_frame>Measured at 6 and 12-months post-loading</time_frame>
    <description>Measurement of modified Plaque Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD measurement</measure>
    <time_frame>Measured at 6 and 12-months post-loading</time_frame>
    <description>Measurement of pocket depth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mSBI measurement</measure>
    <time_frame>Measured at 6 and 12-months post-loading</time_frame>
    <description>Measurement of modified sulcus bleeding index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KM measurement</measure>
    <time_frame>Measured at 6 and 12-months post-loading</time_frame>
    <description>Measurement of keratinized mucosa</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Missing Tooth</condition>
  <condition>Fractured Tooth</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Guided bone regeneration with Bovine Bone Mineral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Guided bone regeneration with freeze dried bone allograft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Guided bone regeneration with Bovine Bone Mineral</intervention_name>
    <description>Guided bone regeneration with Bovine Bone Mineral</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Guided bone regeneration with freeze dried bone allograft</intervention_name>
    <description>Guided bone regeneration with freeze dried bone allograft</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is 18 years or older.&#xD;
&#xD;
          2. Non-smoker or patient has smoking habit and &lt; 1 pack per day.&#xD;
&#xD;
          3. Ability to understand and provide informed consent before starting the study.&#xD;
&#xD;
          4. Ability and willingness to comply with all study requirements.&#xD;
&#xD;
          5. The patient, if of child-bearing potential, has a negative urine pregnancy test.&#xD;
&#xD;
          6. Adequate oral hygiene to allow for implant therapy consistent with standards of care.&#xD;
&#xD;
          7. Adequate primary stability following early implant placement protocols utilizing&#xD;
             Straumann Bone Level implants NC 3.3mm or RC 4.1mm in diameter at all available&#xD;
             implant lengths.&#xD;
&#xD;
          8. One or more teeth in maxilla (11,12,13,14,15,21,22,23,24,25 according to FDI) has been&#xD;
             identified as having a hopeless prognosis requiring extraction leading to a&#xD;
             single-tooth gap requiring implant placement as determined by clinician.&#xD;
&#xD;
          9. Implant site that has a defect and requires bone augmentation. This will be determined&#xD;
             by measuring on the CBCT image the available space for the implant and whether or not&#xD;
             there is enough bone width where the implant is to be placed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient reports current smoking habit &gt; 1 pack per day or tobacco chewing use.&#xD;
&#xD;
          2. History of alcoholism or drug abuse within the past 5 years.&#xD;
&#xD;
          3. Severe bruxism or clenching habits.&#xD;
&#xD;
          4. Patient has significant untreated periodontal disease (grade III or IV), caries, or&#xD;
             clinical or radiographic signs of infection within two adjacent tooth positions of&#xD;
             implant area.&#xD;
&#xD;
          5. History of HIV infection, Hepatitis B or C.&#xD;
&#xD;
          6. Patients with a history of systemic disease that precludes standard dental implant&#xD;
             therapy.&#xD;
&#xD;
          7. Presence of local inflammation or mucosal diseases such as lichen planus&#xD;
&#xD;
          8. Patient history consistent with high risk for subacute bacterial endocarditis&#xD;
&#xD;
          9. Current hematological disorder or coumadin (or similar) therapy&#xD;
&#xD;
         10. Patient currently undergoing chemotherapy&#xD;
&#xD;
         11. Patient history of radiation treatment to the head or neck&#xD;
&#xD;
         12. Physical or mental handicaps that would interfere with patient's ability to exercise&#xD;
             good oral hygiene on a regular basis&#xD;
&#xD;
         13. Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dental Implant</keyword>
  <keyword>Guided Bone Regeneration</keyword>
  <keyword>Contour Augmentation</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>
    <mesh_term>Tooth Fractures</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/NCT03302143
org study id: HSC20120264H
nct id: NCT03302143
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Total of 48 subjects were randomly assigned to treatment groups:

      UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan

      Patients require a maxillary non-molar extraction site that is planned to be replaced by a
      dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) & Regular
      (4.1mm) Crossfit implants in all available lengths.

      Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM
      (control/standard) for contour augmentation.
This comparative, randomized, prospective clinical study is designed to compare clinical
      outcomes and facial bone height and thickness of two different bone grafting techniques after
      augmentation in (Type 2) early implant placement.

      Human subjects who could potentially qualify with the said inclusion criteria will be
      evaluated and screened. 24 human subjects who qualify for the procedure will have a thorough
      evaluation performed after obtaining consent from the patient. All subjects will require
      extraction of maxillary teeth (incisors, canines, premolars), followed by early implant
      placement of the missing teeth after 4 to 8 weeks extraction.

      There will be two subject groups in this study in which the 24 human subjects in will
      randomly be placed by selecting the number "1" or "2" from a hat. 24 human subjects will be
      divided into two groups including 12 subjects using control group design and 12 subjects
      using test group design. 12 subjects will be placed randomly into Group 1 and will undergo
      the flapless extraction and early implant placement with GBR procedure using the control
      group design. 12 subjects will be placed randomly into Group 2 and will undergo the flapless
      extraction and early implant placement with GBR procedure using the test group design.

      During the implant placement visit after 4 to 8 weeks of extraction, patient will be asked to
      select a number from a hat. If the number showed "1" as a control group, autograft , BBM and
      collagen membrane will be used as GBR materials after implant placement. If the number showed
      "2" as a test group, FDBA and collagen membrane will be used as GBR materials after implant
      placement.

      Extraction sites will include maxillary teeth (11,12,13,14,15,21,22,23,24,25 according to
      FDI) having intact adjacent teeth. Implants placed for this study will have a SLActive
      surface, bone level design, Straumann NC 3.3mm or RC 4.1mm in diameter at all available
      implant lengths.

      Control group: early implant placement with autograft plus BBM (Bio-Oss, Geistlich Pharm AG,
      Wolhausen, Switzerland) plus two layers of collagen membrane (BioGide®).

      Test group: early implant placement with FDBA (Straumann Allograft GC®) plus two layers of
      collagen membrane (BioGide®).

      These procedures will follow the guidelines as described by Buser et al. (2008). Implant
      placements will follow standard protocols utilizing tapping and placement with the hand
      ratchet.

      A CBCT radiograph will be made during the screening visit to determine eligibility for the
      study and immediately following implant placement with GBR procedure to provide facial bone
      height and thickness measurements. The second CBCT procedure is not typically a standard of
      care procedure. After 12 months post loading healing time, the patient will receive another
      CBCT. This CBCT is also not a standard of care procedure but can accurately assess the amount
      of facial bone height and thickness maintained during the follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A comparative, randomized, prospective, clinical study
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Facial bone thickness
time frame: Measured at 1 year post-loading
description: Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform
measure: Change in facial bone thickness
time frame: Between implant placement and 1 year post-loading
description: Change in facial bone thickness between implant placement and 1 year post-loading
measure: mPI measurement
time frame: Measured at 6 and 12-months post-loading
description: Measurement of modified Plaque Index
measure: PD measurement
time frame: Measured at 6 and 12-months post-loading
description: Measurement of pocket depth
measure: mSBI measurement
time frame: Measured at 6 and 12-months post-loading
description: Measurement of modified sulcus bleeding index
measure: KM measurement
time frame: Measured at 6 and 12-months post-loading
description: Measurement of keratinized mucosa
arm group label: Control
arm group type: Active Comparator
description: Guided bone regeneration with Bovine Bone Mineral
arm group label: Experimental
arm group type: Experimental
description: Guided bone regeneration with freeze dried bone allograft
intervention type: Procedure
intervention name: Guided bone regeneration with Bovine Bone Mineral
description: Guided bone regeneration with Bovine Bone Mineral
arm group label: Control
intervention type: Procedure
intervention name: Guided bone regeneration with freeze dried bone allograft
description: Guided bone regeneration with freeze dried bone allograft
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Tooth Loss
mesh term: Anodontia
mesh term: Tooth Fractures