<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/NCT03028922</url>
  </required_header>
  <id_info>
    <org_study_id>T-189</org_study_id>
    <nct_id>NCT03028922</nct_id>
  </id_info>
  <brief_title>A 1-year Clinical Investigation on the the CREOS™ XENOGAIN Bone Graft SUBSTITUTE</brief_title>
  <official_title>A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nobel Biocare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nobel Biocare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical investigation is a prospective, multi-centre study to evaluate bone gain after&#xD;
      horizontal augmentation using creos xenogain bone graft substitute. Patients included in the&#xD;
      study are in need of a GBR procedure prior to implant placement in the premolar and posterior&#xD;
      region of the mandible.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical investigation is a prospective, multi-centre study to evaluate bone gain after&#xD;
      horizontal augmentation using creos xenogain bone graft substitute.&#xD;
&#xD;
      Patients included in the study are in need of a GBR procedure prior to implant placement in&#xD;
      the premolar and posterior region of the mandible.&#xD;
&#xD;
      Primary endpoint include the bone gain after 8 months healing period, while secondary&#xD;
      endpoints includes histological analysis 8 months after performance of the augmentation&#xD;
      procedure as well as Implant survival, implant success and marginal bone levels evaluated&#xD;
      over a period of 1 year after definitive prosthetic delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone gain 8 months after bone augmentation procedure for implant placement.</measure>
    <time_frame>8 months</time_frame>
    <description>To evaluate bone gain 8 months after bone augmentation procedure for implant placement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant survival</measure>
    <time_frame>6 months and 1 year after definitive prosthetic delivery</time_frame>
    <description>To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant success</measure>
    <time_frame>6 months and 1 year after definitive prosthetic delivery</time_frame>
    <description>To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marginal bone levels</measure>
    <time_frame>6 months and 1 year after definitive prosthetic delivery</time_frame>
    <description>To demonstrate the changes in marginal bone levels (ΔMBL) around the implants placed in the augmented bone as measured and evaluated by periapical films, 6 months and 1 year after definitive prosthetic delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components</measure>
    <time_frame>8 months</time_frame>
    <description>A bone sample using a trephine bur will be collected after 8 months and prior to implant insertion in order to perform histological analysis. The analysis will include the following parameters: percentage of vital bone and residual graft and connective tissue and if present other non bone components</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soft tissue outcome 1 year after definitive prosthetic delivery</measure>
    <time_frame>1 year</time_frame>
    <description>Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oral health related quality of life assessment</measure>
    <time_frame>1 year</time_frame>
    <description>To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Horizontal Bone Augmentation</condition>
  <arm_group>
    <arm_group_label>creos xenogain</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>creos xenogain</intervention_name>
    <description>GBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible</description>
    <arm_group_label>creos xenogain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects between 18 and 80 years old.&#xD;
&#xD;
          -  Patient has signed informed consent to participate in the study.&#xD;
&#xD;
          -  Patients in need of horizontal ridge augmentation prior to implant placement in the&#xD;
             premolar and posterior region of the mandible&#xD;
&#xD;
          -  Horizontal defect classified as: Horizontal medium defect (Hm) (4-6 mm defect) or&#xD;
             Horizontal large defect (Hl) (≥7 mm defect)&#xD;
&#xD;
          -  Patients presented with a combination defect Horizontal/Vertical with a maximum of 2mm&#xD;
             loss of vertical dimensions (minimal vertical dimension for patient inclusion is 7.5&#xD;
             mm defined as the distance from the anatomical landmark, alveolar nerve or lingual&#xD;
             dehiscence)&#xD;
&#xD;
          -  The subject must be in good physical and mental condition&#xD;
&#xD;
          -  The subject is willing and able to comply with all study related procedures (such as&#xD;
             exercising oral hygiene and attending all follow-up procedures).&#xD;
&#xD;
          -  Full-mouth bleeding score (FMBS) lower than 25%.&#xD;
&#xD;
          -  Full-mouth plaque score (FMPI) lower than 25%.&#xD;
&#xD;
          -  The subject is suitable for a 2-stage surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe bone defect classified as: Vertical medium (Vm) (4-6 mm defect) or Vertical&#xD;
             large, (Vl) (≥7 mm)&#xD;
&#xD;
          -  Medium (Cm) and Large (Cl) classified combination defects Prior bone augmentation in&#xD;
             the area planned for treatment (i.e ridge preservation)&#xD;
&#xD;
          -  Health conditions, which do not permit the surgical (including anesthesia) or&#xD;
             restorative procedure.&#xD;
&#xD;
          -  Any disorders directly in the planned implant area such as previous tumors, chronic&#xD;
             bone disease.&#xD;
&#xD;
          -  Any ongoing application of interfering medication (steroid therapy, bisphosphonate,&#xD;
             etc).&#xD;
&#xD;
          -  Alcohol or drug abuse as noted in subject records or in subject history.&#xD;
&#xD;
          -  Reason to believe that the treatment might have a negative effect on the subject's&#xD;
             overall situation (psychiatric problems), as noted in subject records or history.&#xD;
&#xD;
          -  Heavy smoking (&gt; 10 cigarettes per day).&#xD;
&#xD;
          -  Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of&#xD;
             neglecting doctor's recommendations regarding treatment, food and alcohol intake or&#xD;
             A1c level above 8%.&#xD;
&#xD;
          -  Poor compliance.&#xD;
&#xD;
          -  Active periodontal disease involving the residual dentition.&#xD;
&#xD;
          -  Mucosal diseases in the areas to be treated.&#xD;
&#xD;
          -  Pregnant or lactating women at the time of bone augmentation procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Praxisklinik der Zahnheilkunde am Luisenhospital</name>
      <address>
        <city>Aachen</city>
        <zip>52064</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts Klinikum Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Odontoiatrica - Dipartimento di Neuroscienze, Università di Padova</name>
      <address>
        <city>Padua</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Merli</name>
      <address>
        <city>Rimini</city>
        <zip>47923</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Academy of Belgrade, Oral Surgery</name>
      <address>
        <city>Belgrade</city>
        <zip>11 000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Belgrade, Periodontology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
    <country>Serbia</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>creos xenogain</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/NCT03028922
org study id: T-189
nct id: NCT03028922
lead sponsor: 
has dmc: No
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after
      horizontal augmentation using creos xenogain bone graft substitute. Patients included in the
      study are in need of a GBR procedure prior to implant placement in the premolar and posterior
      region of the mandible.
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after
      horizontal augmentation using creos xenogain bone graft substitute.

      Patients included in the study are in need of a GBR procedure prior to implant placement in
      the premolar and posterior region of the mandible.

      Primary endpoint include the bone gain after 8 months healing period, while secondary
      endpoints includes histological analysis 8 months after performance of the augmentation
      procedure as well as Implant survival, implant success and marginal bone levels evaluated
      over a period of 1 year after definitive prosthetic delivery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bone gain 8 months after bone augmentation procedure for implant placement.
time frame: 8 months
description: To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
measure: Implant survival
time frame: 6 months and 1 year after definitive prosthetic delivery
description: To demonstrate cumulative survival rate of the implants placed in the augmented bone at 6 months and at 1 year after definitive prosthetic delivery.
measure: Implant success
time frame: 6 months and 1 year after definitive prosthetic delivery
description: To demonstrate cumulative success rate of the implants placed in the augmented bone at 6 months and 1 year after definitive prosthetic delivery.
measure: Marginal bone levels
time frame: 6 months and 1 year after definitive prosthetic delivery
description: To demonstrate the changes in marginal bone levels (ΔMBL) around the implants placed in the augmented bone as measured and evaluated by periapical films, 6 months and 1 year after definitive prosthetic delivery
measure: Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components
time frame: 8 months
description: A bone sample using a trephine bur will be collected after 8 months and prior to implant insertion in order to perform histological analysis. The analysis will include the following parameters: percentage of vital bone and residual graft and connective tissue and if present other non bone components
measure: Soft tissue outcome 1 year after definitive prosthetic delivery
time frame: 1 year
description: Soft tissue outcome is a combination of different parameters that include gingival index, bleeding index, keratinized mucosa and pink esthetic score
measure: oral health related quality of life assessment
time frame: 1 year
description: To demonstrate pre- and postoperatively the oral health related quality of life assessment using the Oral Health Impact Profile questionnaire (OHIP-14).
arm group label: creos xenogain
arm group type: Other
description: Patients in need of bone augmentation prior to implant insertion will undergo GBR procedure using Creos xenogain bone graft substitute
intervention type: Device
intervention name: creos xenogain
description: GBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible
arm group label: creos xenogain
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Italy
country: Serbia
responsible party type: Sponsor