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/NCT06017115</url>
    </required_header>
    <id_info>
      <org_study_id>CIR-ECL-2016-03</org_study_id>
      <nct_id>NCT06017115</nct_id>
    </id_info>
    <brief_title>Evaluation of Using Different Screwed Abutment Height</brief_title>
    <official_title>Evaluation of Straumann Bone Level Tapered® Implants Using Screwed Abutment Height in Partially Edentulous Patients: a Randomized Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitat Internacional de Catalunya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitat Internacional de Catalunya</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>
        A prospective randomized controlled clinical trial will be conducted. Study groups will be&#xD;
        assigned as described above. The patients will be randomly divided into two groups in order&#xD;
        to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone&#xD;
        Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant&#xD;
        System, Institut Straumann AG, Basel, Switzerland).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        48 patients will be selected with partial edentulism in the maxilla or mandible, requiring&#xD;
        two dental implants in the posterior areas (molars and premolars).&#xD;
  &#xD;
        Each patient will be randomly allocated in one of the two groups: test group (n=36) or&#xD;
        control group (n=12) and all the implants will be placed by residents of the International&#xD;
        Master in Oral Surgery and Master in Periodontics of the same University.&#xD;
  &#xD;
        Study groups&#xD;
  &#xD;
        Group 1: Two stage approach (cover screw in first surgery and healing abutment in second&#xD;
        surgery) (12 patients)&#xD;
  &#xD;
        Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two&#xD;
        subgroups according to different trans-epithelial height abutment:&#xD;
  &#xD;
          -  Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)&#xD;
  &#xD;
          -  Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)&#xD;
  &#xD;
        Clinical Parameters and Outcomes&#xD;
  &#xD;
          -  Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed&#xD;
             tomography superposed with digital cast models).&#xD;
  &#xD;
          -  Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken&#xD;
             on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.&#xD;
  &#xD;
          -  Probing depth, bleeding on probing and keratinized mucosa width will be measured in the&#xD;
             follow-up visits in 3 different points in buccal (Mesial, center and distal).&#xD;
  &#xD;
          -  VAS Scale: The visual analog scale or visual analog scale (VAS).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 1, 2017</start_date>
    <completion_date type="Anticipated">July 30, 2024</completion_date>
    <primary_completion_date type="Actual">July 30, 2022</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>Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Marginal bone loss</measure>
      <time_frame>After implant loading (baseline)and once every year to 36 months follow-up</time_frame>
      <description>Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Probing depth</measure>
      <time_frame>After implant loading (baseline)and once every year to 36 months follow-up</time_frame>
      <description>Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing</measure>
      <time_frame>After implant loading (baseline)and once every year to 36 months follow-up</time_frame>
      <description>Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Keratinized mucosa width</measure>
      <time_frame>After implant loading (baseline)and once every year to 36 months follow-up</time_frame>
      <description>Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">48</enrollment>
    <condition>Bone Loss</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)</intervention_name>
      <description>Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Test group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent&#xD;
  &#xD;
            2. Overall, healthy subjects&#xD;
  &#xD;
            3. Females and males of at least eighteen-years&#xD;
  &#xD;
            4. Requiring a minimum of two implants (molar and/or premolar teeth)&#xD;
  &#xD;
            5. Adequate oral hygiene (less than 15% FMPS)&#xD;
  &#xD;
            6. Able to follow instructions and attend a regular compliance&#xD;
  &#xD;
            7. Enough bone to place a standard implant of 4.1 mm diameter.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Acute local infection&#xD;
  &#xD;
            2. Occlusal overload with parafunctional activity (assessed clinically)&#xD;
  &#xD;
            3. Large occlusal discrepancies&#xD;
  &#xD;
            4. Untreated periodontal disease assessed by Socransky et al. parameters (≥2mm clinical&#xD;
               attachment loss in two consecutive visits within 1 year)&#xD;
  &#xD;
            5. Smokers (more than 10 cigarettes/day)&#xD;
  &#xD;
            6. Drug and/or alcoholic dependencies&#xD;
  &#xD;
            7. Medical conditions contraindicating implant surgery&#xD;
  &#xD;
            8. History of head and/or neck radiation&#xD;
  &#xD;
            9. Bisphosphonate therapy&#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>
    <overall_official>
      <last_name>Jordi Gargallo-Albiol</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitat Internacional de Catalunya</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universitat Internacional de Catalunya</name>
        <address>
          <city>Barcelona</city>
          <zip>08195</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitat Internacional de Catalunya</investigator_affiliation>
      <investigator_full_name>Jordi Gargallo-Albiol</investigator_full_name>
      <investigator_title>Associate Professor of Oral and Maxillofacial Surgery</investigator_title>
    </responsible_party>
    <keyword>bone loss</keyword>
    <keyword>dental implant</keyword>
    <keyword>bone implant interface</keyword>
    <keyword>Peri implant Endosseous Healing</keyword>
    <keyword>Dental implant abutment</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The investigators will have all the informed consent forms, the clinical study report, the presurgical plan, the CBCT immediately post-surgery, and the outcome variable tables of each follow-up visit.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>The first outcome will be available in July-2022 and the last outcome in July.2024</ipd_time_frame>
    </patient_data>
    <!-- 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/NCT06017115
  org study id: CIR-ECL-2016-03
  nct id: NCT06017115
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A prospective randomized controlled clinical trial will be conducted. Study groups will be
        assigned as described above. The patients will be randomly divided into two groups in order
        to study the influence of prosthetic screw abutment in marginal bone loss (MBL) around Bone
        Level Tapered implants (BLT® Roxolid® SLActive® guided implants, Straumann Dental Implant
        System, Institut Straumann AG, Basel, Switzerland).
  48 patients will be selected with partial edentulism in the maxilla or mandible, requiring
        two dental implants in the posterior areas (molars and premolars).
  
        Each patient will be randomly allocated in one of the two groups: test group (n=36) or
        control group (n=12) and all the implants will be placed by residents of the International
        Master in Oral Surgery and Master in Periodontics of the same University.
  
        Study groups
  
        Group 1: Two stage approach (cover screw in first surgery and healing abutment in second
        surgery) (12 patients)
  
        Group 2: One stage approach (healing cap over trans-epithelial abutments) (36 patients).Two
        subgroups according to different trans-epithelial height abutment:
  
          -  Subgroup 2.1: Screw-retained abutment of 1 mm height (18 patients)
  
          -  Subgroup 2.2: Screw-retained abutment of 2.5 mm height (18 patients)
  
        Clinical Parameters and Outcomes
  
          -  Three-dimensional volumetric changes in hard and soft tissues (Cone-beam computed
             tomography superposed with digital cast models).
  
          -  Marginal bone level (MBL) change: Standardized intraoral periapical x-rays will be taken
             on the day of surgery, 4, 6, 12, 24 and 36 months following surgery.
  
          -  Probing depth, bleeding on probing and keratinized mucosa width will be measured in the
             follow-up visits in 3 different points in buccal (Mesial, center and distal).
  
          -  VAS Scale: The visual analog scale or visual analog scale (VAS).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Each patient will be randomly allocated in one of the two groups: test group (n=36) or control group (n=12)
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Marginal bone loss
  time frame: After implant loading (baseline)and once every year to 36 months follow-up
  description: Periimplant bone level by measuring from the implant platform to the first bone to implant contact. Messuret in 2 points: MESIAL AND DISTAL with intra-oral XR. (measured in millimeters)
  measure: Probing depth
  time frame: After implant loading (baseline)and once every year to 36 months follow-up
  description: Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
  measure: Bleeding on probing
  time frame: After implant loading (baseline)and once every year to 36 months follow-up
  description: Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
  measure: Keratinized mucosa width
  time frame: After implant loading (baseline)and once every year to 36 months follow-up
  description: Measuring this outcomes at 4 different points .(Mesial Buccal, Center Buccal, Distal Buccal and central lingual) (measured in millimeters).
  arm group label: Control group
  arm group type: Active Comparator
  description: Group 1: 2 stage approach (cover screw) (12 patients): cover screw is placed over the dental implants in the first surgery and a second surgery will be performed to expose the implants and placing a healing abutment after 2-4 months, DEVICES: COVER SCREW (first surgery) and HEALING ABUTMENT (second surgery)
  arm group label: Test group
  arm group type: Experimental
  description: Group 2: Protective plastic cap over different definitive trans-epithelial abutments are placed in the unic surgery performed (36 patients): Definitive transepithelial abutments will be placed the same day of the implant placement surgery. DEVICE: DEFINITIVE TRANSEPITHELIAL ABUTMENT
  intervention type: Device
  intervention name: Dental implant placement with COVER SCREW (two surgeries in control group) or DEFINITIVE TRANSEPITHELIAL ABUTMENT (one surgery in test group)
  description: Dental implant placement using cover screws (first surgery) and a healing abutment (second surgery) or definitive transepithelial abutments the same day of the implant placement (one unit surgery)
  arm group label: Control group
  arm group label: Test group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jordi Gargallo-Albiol
  role: Principal Investigator
  affiliation: Universitat Internacional de Catalunya
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Universitat Internacional de Catalunya
  investigator full name: Jordi Gargallo-Albiol
  investigator title: Associate Professor of Oral and Maxillofacial Surgery
  sharing ipd: Yes
  ipd description: The investigators will have all the informed consent forms, the clinical study report, the presurgical plan, the CBCT immediately post-surgery, and the outcome variable tables of each follow-up visit.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: The first outcome will be available in July-2022 and the last outcome in July.2024