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/NCT05990283</url>
    </required_header>
    <id_info>
      <org_study_id>0044</org_study_id>
      <nct_id>NCT05990283</nct_id>
    </id_info>
    <brief_title>Socket Shield Technique and Guided Bone Regeneration</brief_title>
    <official_title>Comparison of Non-grafted Socket Shield Technique With Guided Bone Regeneration in Immediate Implant Placement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kutahya Health Sciences University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kutahya Health Sciences University</source>
    <oversight_info>
      <has_dmc>No</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>
        Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry,&#xD;
        Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the&#xD;
        maxillary esthetic region and required implant placement were included in this randomized&#xD;
        clinical trial. Before implant surgery, patients were randomized into socket shield technique&#xD;
        and guided bone regeneration groups. While the buccal gap was untreated in the socket shield&#xD;
        group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket&#xD;
        depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal&#xD;
        thickness were recorded at the permanent restoration and the postoperative first year.&#xD;
        Horizontal bone level and vertical bone level were assessed with cone beam computed&#xD;
        tomography images taken before the surgery and one year after prosthesis insertion. The pink&#xD;
        esthetic score was evaluated with intraoral photographs taken before the surgical procedure&#xD;
        and first-year follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study aimed to compare the non-grafted socket shield technique with simultaneously&#xD;
        guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and&#xD;
        radiographic parameters. Within the scope, immediate implant placement was applied to&#xD;
        randomized groups (socket shield technique and guided bone regeneration). Immediate implant&#xD;
        placement was performed following shield preparation in the shield group, and guided bone&#xD;
        regeneration was applied in the regeneration group. A temporary non-functional immediate&#xD;
        prosthesis was inserted at the same visit. After four months, permanent restorations were&#xD;
        applied. Clinical, radiographic, and esthetic parameters were compared between two groups at&#xD;
        baseline and first-year follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2019</start_date>
    <completion_date type="Actual">January 20, 2023</completion_date>
    <primary_completion_date type="Actual">December 27, 2021</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Peri-implant probing depth</measure>
      <time_frame>Four months after implant restoration and first-year follow-up</time_frame>
      <description>Probing depth measured by Williams periodontal probe</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified plaque index</measure>
      <time_frame>Four months after implant restoration and first-year follow-up</time_frame>
      <description>An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Modified bleeding index</measure>
      <time_frame>Four months after implant restoration and first-year follow-up</time_frame>
      <description>An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Keratinized mucosa width</measure>
      <time_frame>Four months after implant restoration and first-year follow-up</time_frame>
      <description>The distance from the peri-implant mucosa margin to the mucogingival junction</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mucosal thickness</measure>
      <time_frame>Four months after implant restoration and first-year follow-up</time_frame>
      <description>The thickness measured at 1.5 mm from the margin by the endodontic spreader</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radiographic bone level in the horizontal dimension</measure>
      <time_frame>Before implant surgery and first year follow-up</time_frame>
      <description>Horizontal bone level measured at cone beam computed tomography images</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radiographic bone level in the vertical dimension</measure>
      <time_frame>Before implant surgery and first year follow-up</time_frame>
      <description>Vertical bone level measured at cone beam computed tomography images</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pink esthetic score</measure>
      <time_frame>Before implant surgery and first year follow-up</time_frame>
      <description>A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">24</enrollment>
    <condition>Immediate Implant Placement</condition>
    <arm_group>
      <arm_group_label>Socket shield technique with immediate implant placement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Guided bone regeneration with immediate implant placement</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Socket shield technique</intervention_name>
      <description>For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge.</description>
      <arm_group_label>Socket shield technique with immediate implant placement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Guided bone regeneration</intervention_name>
      <description>For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.</description>
      <arm_group_label>Guided bone regeneration with immediate implant placement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with the health status of American Society of Anesthesiologists class I or&#xD;
               II,&#xD;
  &#xD;
            -  Nonsmokers,&#xD;
  &#xD;
            -  Unrestorable single-rooted tooth in the maxillary esthetic region,&#xD;
  &#xD;
            -  Periodontally healthy, non-mobile teeth,&#xD;
  &#xD;
            -  Single implant placement,&#xD;
  &#xD;
            -  Minimum 3-5 mm available vertical bone apical to the apex,&#xD;
  &#xD;
            -  Intact socket wall after extraction.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Medically compromised patients, especially uncontrolled diabetes,&#xD;
  &#xD;
            -  Psychiatric problems,&#xD;
  &#xD;
            -  Pregnancy, lactation, or suspicion of pregnancy,&#xD;
  &#xD;
            -  A history of radiation therapy to the head and neck region or immunosuppressive&#xD;
               therapy,&#xD;
  &#xD;
            -  Metabolic bone disorder or the presence of drugs known to affect bone metabolism,&#xD;
  &#xD;
            -  Poor plaque control,&#xD;
  &#xD;
            -  Vertical root fracture on the buccal surface or a horizontal fracture below the bone&#xD;
               level,&#xD;
  &#xD;
            -  External or internal resorption affecting the buccal part of the root,&#xD;
  &#xD;
            -  Acute infection in the area intended for implant placement,&#xD;
  &#xD;
            -  Refusal to attend follow-up appointments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ezgi Ceylan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Kutahya Health Sciences University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kutahya Health Sciences University</name>
        <address>
          <city>Kutahya</city>
          <zip>43100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>November 2019</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kutahya Health Sciences University</investigator_affiliation>
      <investigator_full_name>Ezgi Gürbüz</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>bone regeneration</keyword>
    <keyword>dental implant</keyword>
    <keyword>esthetics</keyword>
    <keyword>grafts</keyword>
    <keyword>socket shield technique</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05990283
  org study id: 0044
  nct id: NCT05990283
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Among the individuals who applied to the Department of Periodontology, Faculty of Dentistry,
        Health Sciences University between 2019 and 2021, patients with an unrestorable tooth in the
        maxillary esthetic region and required implant placement were included in this randomized
        clinical trial. Before implant surgery, patients were randomized into socket shield technique
        and guided bone regeneration groups. While the buccal gap was untreated in the socket shield
        group, a xenograft, and membrane were applied in the regeneration group. Peri-implant pocket
        depth, modified plaque index, modified bleeding index, keratinized mucosa width, and mucosal
        thickness were recorded at the permanent restoration and the postoperative first year.
        Horizontal bone level and vertical bone level were assessed with cone beam computed
        tomography images taken before the surgery and one year after prosthesis insertion. The pink
        esthetic score was evaluated with intraoral photographs taken before the surgical procedure
        and first-year follow-up.
  This study aimed to compare the non-grafted socket shield technique with simultaneously
        guided bone regeneration in immediate implant placement in terms of clinical, esthetic, and
        radiographic parameters. Within the scope, immediate implant placement was applied to
        randomized groups (socket shield technique and guided bone regeneration). Immediate implant
        placement was performed following shield preparation in the shield group, and guided bone
        regeneration was applied in the regeneration group. A temporary non-functional immediate
        prosthesis was inserted at the same visit. After four months, permanent restorations were
        applied. Clinical, radiographic, and esthetic parameters were compared between two groups at
        baseline and first-year follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Peri-implant probing depth
  time frame: Four months after implant restoration and first-year follow-up
  description: Probing depth measured by Williams periodontal probe
  measure: Modified plaque index
  time frame: Four months after implant restoration and first-year follow-up
  description: An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
  measure: Modified bleeding index
  time frame: Four months after implant restoration and first-year follow-up
  description: An index evaluated by the Williams periodontal probe indicates a minimum of 0 and a maximum of 3, with higher values indicating a worse outcome
  measure: Keratinized mucosa width
  time frame: Four months after implant restoration and first-year follow-up
  description: The distance from the peri-implant mucosa margin to the mucogingival junction
  measure: Mucosal thickness
  time frame: Four months after implant restoration and first-year follow-up
  description: The thickness measured at 1.5 mm from the margin by the endodontic spreader
  measure: Radiographic bone level in the horizontal dimension
  time frame: Before implant surgery and first year follow-up
  description: Horizontal bone level measured at cone beam computed tomography images
  measure: Radiographic bone level in the vertical dimension
  time frame: Before implant surgery and first year follow-up
  description: Vertical bone level measured at cone beam computed tomography images
  measure: Pink esthetic score
  time frame: Before implant surgery and first year follow-up
  description: A score as assessed by intraoral photographs, showing a minimum of 0 and a maximum of 14, with higher values indicating a better esthetic result
  arm group label: Socket shield technique with immediate implant placement
  arm group type: Experimental
  description: For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth.
  arm group label: Guided bone regeneration with immediate implant placement
  arm group type: Experimental
  description: For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.
  intervention type: Procedure
  intervention name: Socket shield technique
  description: For the patients in the shield group, shields were prepared with the Root Membrane Kit. After the palatal part was removed, the buccal fragment was prepared at the crest level, and an internal bevel chamfer was formed on the fragment. Implants were placed 3-4 mm apical to the gingival margin of the adjacent teeth. Healing caps were placed, and the periphery of the caps was covered with an absorbable gelatin sponge.
  arm group label: Socket shield technique with immediate implant placement
  intervention type: Procedure
  intervention name: Guided bone regeneration
  description: For the patients in the regeneration group, teeth were extracted atraumatically, implants were placed 3-4 mm to the gingival margin, and the space between the implant and buccal bone was filled with anorganic bovine bone graft at the time of implant placement. The graft particles were covered by a pericardium membrane. The membrane was fixed to the bone with titanium pins.
  arm group label: Guided bone regeneration with immediate implant placement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ezgi Ceylan, PhD
  role: Principal Investigator
  affiliation: Kutahya Health Sciences University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kutahya Health Sciences University
  investigator full name: Ezgi Gürbüz
  investigator title: Assistant Professor
  sharing ipd: No