<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/NCT03784430</url>
  </required_header>
  <id_info>
    <org_study_id>Winsix 1</org_study_id>
    <nct_id>NCT03784430</nct_id>
  </id_info>
  <brief_title>Soft and Hard Tissue Changes After Immediate Single-tooth Replacement</brief_title>
  <official_title>Soft and Hard Tissue Changes After Immediate Single-tooth Replacement With or Without a Submarginal Connective Tissue Graft</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università Vita-Salute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università Vita-Salute San Raffaele</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 recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft&#xD;
      concurrent with immediate implantation may contribute to the stability of gingival level and&#xD;
      the augmentation of soft tissue contour. However, most included studies did not have a&#xD;
      control group to directly demonstrate the benefit of an immediate implant combined with soft&#xD;
      tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized&#xD;
      controlled clinical trial with a parallel design is to evaluate the influence of the&#xD;
      connective tissue graft on the buccal bone alterations after tooth extraction and immediate&#xD;
      implant placement by means of cone beam computer tomography (CBCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will be selected on a consecutive basis, among individuals, above the age of&#xD;
      18 years, referred to Dental Clinic of the San Raffaele University, with a single failing&#xD;
      tooth in the upper and lower jaw from second premolar to second premolar, candidates for a&#xD;
      single implant restoration. After local anesthesia, a split-full-split thickness envelope&#xD;
      flap, as described for the treatment of multiple gingival recessions by Zucchelli and de&#xD;
      Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The&#xD;
      immediate implantation procedure will be carried out according to the manufacture protocol&#xD;
      and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone&#xD;
      crest. In the group &quot;Implant+CTG&quot; a connective tissue graft (CTG), resulting from the&#xD;
      extraoral de-epithelialization with the knife blade of a free gingival graft harvested from&#xD;
      the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and&#xD;
      positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the&#xD;
      buccal crest. Patients will be followed for 6 months after implant placement and 6 months&#xD;
      after loading.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 9, 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>Volumetric buccal bone changes</measure>
    <time_frame>6 months</time_frame>
    <description>Ratio scale - lower values represent a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Volumetric buccal soft tissue changes</measure>
    <time_frame>6 months</time_frame>
    <description>Ratio scale - higher values represent a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Buccal soft tissue changes</measure>
    <time_frame>6 months</time_frame>
    <description>Ratio scale - higher values represent a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perception outcomes</measure>
    <time_frame>1 week and 6 months</time_frame>
    <description>Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Implant</condition>
  <arm_group>
    <arm_group_label>Implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Immediate dental implant placement</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Implant+CTG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediate dental implant placement with CTG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate dental implant placement</intervention_name>
    <description>Tooth will be extracted and a dental implant will be positioned at the same time.</description>
    <arm_group_label>Implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate dental implant placement with CTG</intervention_name>
    <description>Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.</description>
    <arm_group_label>Implant+CTG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a single tooth to be extracted for endodontic failure, fractures, root caries or&#xD;
             resorption in the maxillary and mandibular area from second premolar to second&#xD;
             premolar&#xD;
&#xD;
          -  patient in good systemic health, with no contraindication for oral surgical&#xD;
             interventions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with impaired systemic diseases that will interfere with surgical&#xD;
             interventions (autoimmune diseases, uncontrolled diabetes)&#xD;
&#xD;
          -  assumption of bisphosphonate&#xD;
&#xD;
          -  smoking more than 10 cigarettes a day&#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>Massimo de Sanctis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università Vita-Salute San Raffaele</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massimo de Sanctis</name>
      <address>
        <city>Milan</city>
        <state>Mi</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Schneider D, Schmidlin PR, Philipp A, Annen BM, Ronay V, Hammerle CH, Attin T, Jung RE. Labial soft tissue volume evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2014 Jun;41(6):612-7. doi: 10.1111/jcpe.12246. Epub 2014 Mar 26.</citation>
    <PMID>24593810</PMID>
  </reference>
  <reference>
    <citation>Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.</citation>
    <PMID>23163915</PMID>
  </reference>
  <reference>
    <citation>Chappuis V, Bornstein MM, Buser D, Belser U. Influence of implant neck design on facial bone crest dimensions in the esthetic zone analyzed by cone beam CT: a comparative study with a 5-to-9-year follow-up. Clin Oral Implants Res. 2016 Sep;27(9):1055-64. doi: 10.1111/clr.12692. Epub 2015 Sep 15.</citation>
    <PMID>26370904</PMID>
  </reference>
  <reference>
    <citation>Schropp L, Wenzel A, Spin-Neto R, Stavropoulos A. Fate of the buccal bone at implants placed early, delayed, or late after tooth extraction analyzed by cone beam CT: 10-year results from a randomized, controlled, clinical study. Clin Oral Implants Res. 2015 May;26(5):492-500. doi: 10.1111/clr.12424. Epub 2014 Jun 2.</citation>
    <PMID>24890861</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università Vita-Salute San Raffaele</investigator_affiliation>
    <investigator_full_name>Massimo de Sanctis</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03784430
org study id: Winsix 1
nct id: NCT03784430
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A recent systematic review (Lee et al, 2016) reported that placement of a soft tissue graft
      concurrent with immediate implantation may contribute to the stability of gingival level and
      the augmentation of soft tissue contour. However, most included studies did not have a
      control group to directly demonstrate the benefit of an immediate implant combined with soft
      tissue graft (IMITG) compared to immediate implant alone.The objective of this randomized
      controlled clinical trial with a parallel design is to evaluate the influence of the
      connective tissue graft on the buccal bone alterations after tooth extraction and immediate
      implant placement by means of cone beam computer tomography (CBCT).
All participants will be selected on a consecutive basis, among individuals, above the age of
      18 years, referred to Dental Clinic of the San Raffaele University, with a single failing
      tooth in the upper and lower jaw from second premolar to second premolar, candidates for a
      single implant restoration. After local anesthesia, a split-full-split thickness envelope
      flap, as described for the treatment of multiple gingival recessions by Zucchelli and de
      Sanctis (2000), will be elevated and the tooth will be extracted a-traumatically. The
      immediate implantation procedure will be carried out according to the manufacture protocol
      and 1mm of the transmucosal portion of the implant will be positioned under the buccal bone
      crest. In the group "Implant+CTG" a connective tissue graft (CTG), resulting from the
      extraoral de-epithelialization with the knife blade of a free gingival graft harvested from
      the palate, will be anchored at the anatomic papillae with 2 horizontal mattress sutures and
      positioned 1 mm coronal to the buccal bone crest and in the apical direction 2 mm above the
      buccal crest. Patients will be followed for 6 months after implant placement and 6 months
      after loading.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Volumetric buccal bone changes
time frame: 6 months
description: Ratio scale - lower values represent a better outcome
measure: Volumetric buccal soft tissue changes
time frame: 6 months
description: Ratio scale - higher values represent a better outcome
measure: Buccal soft tissue changes
time frame: 6 months
description: Ratio scale - higher values represent a better outcome
measure: Patient perception outcomes
time frame: 1 week and 6 months
description: Visual Analogic Scale - values from '0=no pain' to '10=worst pain imaginable'
arm group label: Implant
arm group type: Active Comparator
description: Immediate dental implant placement
arm group label: Implant+CTG
arm group type: Experimental
description: Immediate dental implant placement with CTG.
intervention type: Procedure
intervention name: Immediate dental implant placement
description: Tooth will be extracted and a dental implant will be positioned at the same time.
arm group label: Implant
intervention type: Procedure
intervention name: Immediate dental implant placement with CTG
description: Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.
arm group label: Implant+CTG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Massimo de Sanctis, MD
role: Principal Investigator
affiliation: Università Vita-Salute San Raffaele
facility: 
country: Italy
citation: Schneider D, Schmidlin PR, Philipp A, Annen BM, Ronay V, Hammerle CH, Attin T, Jung RE. Labial soft tissue volume evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2014 Jun;41(6):612-7. doi: 10.1111/jcpe.12246. Epub 2014 Mar 26.
PMID: 24593810
citation: Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
PMID: 23163915
citation: Chappuis V, Bornstein MM, Buser D, Belser U. Influence of implant neck design on facial bone crest dimensions in the esthetic zone analyzed by cone beam CT: a comparative study with a 5-to-9-year follow-up. Clin Oral Implants Res. 2016 Sep;27(9):1055-64. doi: 10.1111/clr.12692. Epub 2015 Sep 15.
PMID: 26370904
citation: Schropp L, Wenzel A, Spin-Neto R, Stavropoulos A. Fate of the buccal bone at implants placed early, delayed, or late after tooth extraction analyzed by cone beam CT: 10-year results from a randomized, controlled, clinical study. Clin Oral Implants Res. 2015 May;26(5):492-500. doi: 10.1111/clr.12424. Epub 2014 Jun 2.
PMID: 24890861
responsible party type: Principal Investigator
investigator affiliation: Università Vita-Salute San Raffaele
investigator full name: Massimo de Sanctis
investigator title: Prof.
sharing ipd: No