xml: <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/NCT05979246</url>
    </required_header>
    <id_info>
      <org_study_id>MIS Implants Technologies</org_study_id>
      <nct_id>NCT05979246</nct_id>
    </id_info>
    <brief_title>Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic Patients</brief_title>
    <official_title>A Comparative Prospective Study to Evaluate the Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MIS Implant Technologies, Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Rambam Health Care Campus</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>MIS Implant Technologies, Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this clinical, prospective study involving implants with a superhydrophilic&#xD;
        surface is to compare the changes of the peri-implant tissues and the survival rate between&#xD;
        diabetics and non-diabetics patients, after 12 months of loading.&#xD;
  &#xD;
        hypothesis: It is not expected to find any short-term differences in failures and marginal&#xD;
        bone loss between the diabetic and non-diabetic patients. On the longer term higher marginal&#xD;
        bone loss may affect the diabetic group 40 patients who are planned to undergo implant&#xD;
        installation will be enrolled in the study.&#xD;
  &#xD;
        The patients will be divided into 2 groups:&#xD;
  &#xD;
          -  Test group - 20 patients diagnosed with type 2 diabetes with 10&gt;HbA1C&gt;7.5% values&#xD;
  &#xD;
          -  Control group - 20 non-diabetic patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In recent years, our understanding of the primary processes that affect bone growth around&#xD;
        implants has progressed. It was found that the standard surface of most implants is not&#xD;
        hydrophilic enough; therefore, it is necessary to increase the healing time to allow&#xD;
        sufficient bony apposition at the implant interface, until reaching a satisfactory&#xD;
        load-bearing capacity. Studies have demonstrated that surface superhydrophilicity can be&#xD;
        gained following storage in an isotonic solution (NaCl); this feature leads to an earlier&#xD;
        bone apposition and higher anchorage, already after the very first weeks of implantation.&#xD;
  &#xD;
        Hypothesis: It is not expected to find any short-term differences in failures and marginal&#xD;
        bone loss between the diabetic and non-diabetic patients. On the longer term higher marginal&#xD;
        bone loss may affect the diabetic group.&#xD;
  &#xD;
        Aim:to compare the changes of the peri-implant tissues and the survival rate between&#xD;
        diabetics and non-diabetics patients, after 12 months of loading.&#xD;
  &#xD;
        Methods and Materials: 40 patients who are planned to undergo implant installation will be&#xD;
        enrolled in the study, at the department of Periodontology at the School of postgraduate&#xD;
        dentistry in the Rambam Health Care Center. .&#xD;
  &#xD;
        The patients will be divided into 2 groups:&#xD;
  &#xD;
          -  Test group - 20 patients diagnosed with type 2 diabetes with 10&gt;HbA1C&gt;7.5% values&#xD;
  &#xD;
          -  Control group - 20 non-diabetic patients. Visit 0 - Screening Visit 1 - Surgical&#xD;
             procedure (± 8 weeks)&#xD;
  &#xD;
        After insertion of the implants, the following surgical indicators will be taken:&#xD;
  &#xD;
          1. Stability of the implants will be measured using an Osstell device with a fitted peg&#xD;
             screwed into the implant neck; unit is given as an arbitrary implant stability quotient&#xD;
             (ISQ).&#xD;
  &#xD;
          2. Register bone quality type 1-4 according to the doctor report using Bone classification&#xD;
             of Lekholm &amp; Zarb ,1985.&#xD;
  &#xD;
        Visit 2 - suture removal (10 ±3days) Visit 3 (surgical uncovering) 12 weeks after&#xD;
        implantation (±8 weeks) Visit 4 (follow-up) 16 weeks after implantation (± 8 weeks) :this&#xD;
        visit includes periodontal examination (PD, BOP, PI, GI) and GCF sampling.&#xD;
  &#xD;
        Visit 5 ( Follow up ) 12 months after rehabilitation (± 4 weeks) :Clinical and radiographic&#xD;
        assessment of the periimplant mucosa&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>
      <intervention_model_description>40 patients who are planned to undergo implant installation will be enrolled in the study, at the department of Periodontology at the School of postgraduate dentistry in the Rambam Health Care Center.&#xD;
  The patients will be divided into 2 groups:&#xD;
  Test group - 20 patients diagnosed with type 2 diabetes with 10&gt;HbA1C&gt;7.5% values&#xD;
  Control group - 20 non-diabetic patients.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>marginal bone loss</measure>
      <time_frame>one year after loading</time_frame>
      <description>radiographic bone resorption around the implant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival rate</measure>
      <time_frame>12 weeks after implantation</time_frame>
      <description>Implant stability measurements by Osstell.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Diabetes</condition>
    <arm_group>
      <arm_group_label>Diabetic patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>undergo implant installation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lance CLEAR dental implant</intervention_name>
      <description>The surgical procedure will be performed by experienced periodontists, all implants will be at least Ø 3.75 mm and 8-11.5 mm long. After reflecting the flaps, a bone biopsy will be harvested as part of the drilling procedure using a Ø 2.4 mm trephine drill and the implants will be seated into a crestal position</description>
      <arm_group_label>Diabetic patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Ages ≥18.&#xD;
  &#xD;
            2. A properly signed and dated consent form.&#xD;
  &#xD;
            3. The need to perform a dental implant (up to two dental implants will be selected for&#xD;
               the patient).&#xD;
  &#xD;
            4. The existence of sufficient alveolar bone that allows the installation of implants of&#xD;
               standard size (diameter 3.75 or above and height of at least 8 mm).&#xD;
  &#xD;
            5. Patients who will receive a fixed restoration (a crown or three units bridge)&#xD;
  &#xD;
            6. A type 2 diabetes with 10 &gt; A1C&gt;7.5 % values but not above 10, or non-diabetic patient&#xD;
               (control).&#xD;
  &#xD;
            7. Meeting the study schedules and attending the study visits.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The presence of an active periodontal disease (PD≥6 mm with bleeding on probing).&#xD;
  &#xD;
            2. Smoking more than 10 cigarettes a day.&#xD;
  &#xD;
            3. Pharmacological condition which can affect the healing of soft or hard tissue.&#xD;
  &#xD;
            4. Past radiation therapy to the head and neck.&#xD;
  &#xD;
            5. Patients under medications with known effects on bone metabolism (e.g. steroids,&#xD;
               anti-TNF-α), antibiotics therapy in the previous months.&#xD;
  &#xD;
            6. Impaired occlusion that can lead to pathologies.&#xD;
  &#xD;
            7. Pregnancy and lactating.&#xD;
  &#xD;
            8. A patient who needs local bone augmentation.&#xD;
  &#xD;
            9. Using removable prosthesis in the implantation area.&#xD;
  &#xD;
           10. Subjects who are currently enrolled, recently participated (within 30 days prior to&#xD;
               screening), or planning to enroll in another study that may conflict with protocol&#xD;
               requirements or may confound the subject results in this trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Michal Malka</last_name>
      <phone>+972-54-7257128</phone>
      <email>michal.malka@dentsplysirona.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Liron Eliezer</last_name>
      <phone>+972-50-7735100</phone>
      <email>l_eliezer@rambam.health.gov.il</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979246
  org study id: MIS Implants Technologies
  nct id: NCT05979246
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The aim of this clinical, prospective study involving implants with a superhydrophilic
        surface is to compare the changes of the peri-implant tissues and the survival rate between
        diabetics and non-diabetics patients, after 12 months of loading.
  
        hypothesis: It is not expected to find any short-term differences in failures and marginal
        bone loss between the diabetic and non-diabetic patients. On the longer term higher marginal
        bone loss may affect the diabetic group 40 patients who are planned to undergo implant
        installation will be enrolled in the study.
  
        The patients will be divided into 2 groups:
  
          -  Test group - 20 patients diagnosed with type 2 diabetes with 10>HbA1C>7.5% values
  
          -  Control group - 20 non-diabetic patients.
  In recent years, our understanding of the primary processes that affect bone growth around
        implants has progressed. It was found that the standard surface of most implants is not
        hydrophilic enough; therefore, it is necessary to increase the healing time to allow
        sufficient bony apposition at the implant interface, until reaching a satisfactory
        load-bearing capacity. Studies have demonstrated that surface superhydrophilicity can be
        gained following storage in an isotonic solution (NaCl); this feature leads to an earlier
        bone apposition and higher anchorage, already after the very first weeks of implantation.
  
        Hypothesis: It is not expected to find any short-term differences in failures and marginal
        bone loss between the diabetic and non-diabetic patients. On the longer term higher marginal
        bone loss may affect the diabetic group.
  
        Aim:to compare the changes of the peri-implant tissues and the survival rate between
        diabetics and non-diabetics patients, after 12 months of loading.
  
        Methods and Materials: 40 patients who are planned to undergo implant installation will be
        enrolled in the study, at the department of Periodontology at the School of postgraduate
        dentistry in the Rambam Health Care Center. .
  
        The patients will be divided into 2 groups:
  
          -  Test group - 20 patients diagnosed with type 2 diabetes with 10>HbA1C>7.5% values
  
          -  Control group - 20 non-diabetic patients. Visit 0 - Screening Visit 1 - Surgical
             procedure (± 8 weeks)
  
        After insertion of the implants, the following surgical indicators will be taken:
  
          1. Stability of the implants will be measured using an Osstell device with a fitted peg
             screwed into the implant neck; unit is given as an arbitrary implant stability quotient
             (ISQ).
  
          2. Register bone quality type 1-4 according to the doctor report using Bone classification
             of Lekholm & Zarb ,1985.
  
        Visit 2 - suture removal (10 ±3days) Visit 3 (surgical uncovering) 12 weeks after
        implantation (±8 weeks) Visit 4 (follow-up) 16 weeks after implantation (± 8 weeks) :this
        visit includes periodontal examination (PD, BOP, PI, GI) and GCF sampling.
  
        Visit 5 ( Follow up ) 12 months after rehabilitation (± 4 weeks) :Clinical and radiographic
        assessment of the periimplant mucosa
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: 40 patients who are planned to undergo implant installation will be enrolled in the study, at the department of Periodontology at the School of postgraduate dentistry in the Rambam Health Care Center.
  The patients will be divided into 2 groups:
  Test group - 20 patients diagnosed with type 2 diabetes with 10>HbA1C>7.5% values
  Control group - 20 non-diabetic patients.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: marginal bone loss
  time frame: one year after loading
  description: radiographic bone resorption around the implant
  measure: Survival rate
  time frame: 12 weeks after implantation
  description: Implant stability measurements by Osstell.
  arm group label: Diabetic patients
  arm group type: Experimental
  description: undergo implant installation
  intervention type: Device
  intervention name: Lance CLEAR dental implant
  description: The surgical procedure will be performed by experienced periodontists, all implants will be at least Ø 3.75 mm and 8-11.5 mm long. After reflecting the flaps, a bone biopsy will be harvested as part of the drilling procedure using a Ø 2.4 mm trephine drill and the implants will be seated into a crestal position
  arm group label: Diabetic patients
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michal Malka
  phone: +972-54-7257128
  email: michal.malka@dentsplysirona.com
  last name: Liron Eliezer
  phone: +972-50-7735100
  email: l_eliezer@rambam.health.gov.il
  responsible party type: Sponsor