<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/NCT03290729</url>
  </required_header>
  <id_info>
    <org_study_id>REX_i</org_study_id>
    <nct_id>NCT03290729</nct_id>
  </id_info>
  <brief_title>Wedge Implant Narrow Crests: Multi-center Clinical Study</brief_title>
  <official_title>Wedge Implant for Minimally Invasive Treatment of Narrow Crests: a Prospective Multi-center Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Piezosurgery Academy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Piezosurgery Academy</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>
      This study was designed as a multicentric prospective clinical trial to assess the clinical,&#xD;
      biological and patient's perceived success of new wedge-shaped dental implants inserted in&#xD;
      narrow ridges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to the loss of dental elements, the bone crest undergoes a significant remodeling. Bone&#xD;
      resorption begins immediately after dental extraction with a 40-60% reduction in horizontal&#xD;
      and vertical direction of the alveolar ridge during the first 2 years. The most significant&#xD;
      bone loss after tooth extraction occurs within the first 3 months, although modeling and&#xD;
      remodeling of the alveoli have a great variability of time: bone structure and organization&#xD;
      may not be complete even 24 weeks after dental extraction.&#xD;
&#xD;
      It is now known that crestal remodeling is closely related to the disappearance of the bundle&#xD;
      bone, which is more representative of the buccal appearance of the alveolus. Its&#xD;
      disappearance, especially in thin periodontal biotopes, can lead to significant recessions of&#xD;
      hard and soft tissues.&#xD;
&#xD;
      Moreover, with a variable percentage, in many patients, crestal resorption continues over&#xD;
      time due to a combination of factors involved: anatomical, metabolic and mechanical. Among&#xD;
      these, the use of removable total or partial dentures can play an important role in&#xD;
      accelerating the resurfacing process.&#xD;
&#xD;
      With these premises, it is common to find patients with atrophic crests when processing plans&#xD;
      that provide implant support prosthetic rehabilitation.&#xD;
&#xD;
      A crestal bone thickness of at least 6 mm in the buco-lingual sense is considered sufficient&#xD;
      to safely place a plant with a diameter of 4 mm. But when the width is lower, a variety of&#xD;
      procedures and techniques have been proposed in literature that allow recreate the volumes&#xD;
      needed for implant placement.&#xD;
&#xD;
      Horizontal lifting techniques with bone blocks (autologous, alloplastic, xeno-graft), guided&#xD;
      bone regeneration, crest expansion technique have demonstrated a good long-term&#xD;
      predictability of the inserted devices. However, some negatives related to these techniques&#xD;
      need to be considered, such as increased morbidity for the patient, demand for advanced&#xD;
      surgical skills for the operator, increased treatment costs, and increased therapy times.&#xD;
&#xD;
      Because of these observations, a new implant design has been proposed for specific use in&#xD;
      narrow ridges. Its wedge shape and press-fit insertion make it possible to position it with a&#xD;
      minimally invasive preparation of the implant site, performed with ultrasound technique.&#xD;
&#xD;
      Therefore, the use of this implant could allow effective and minimally invasive treatment of&#xD;
      narrow edentulous crests up to 4 mm, with significant benefits to the patient in terms of&#xD;
      morbidity, treatment costs and time.&#xD;
&#xD;
      Twelve clinical centers will treat patients with insertion of wedge-shaped implants in thin&#xD;
      crests with a specific surgical protocol and clinical outcomes will be collected and&#xD;
      analyzed.&#xD;
&#xD;
      The chosen medical device will be the Rex Tissue Level implant System. For each implant&#xD;
      inserted, the clinical parameters will be recorded up to 5 years after insertion.&#xD;
&#xD;
      In addition, intermediate evaluations will be carried out at 1 year and 3 years after&#xD;
      installation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</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>multicenter single cohort prospective study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implant survival rate</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>health of the inserted implants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>surgical procedure evaluation</measure>
    <time_frame>during surgery</time_frame>
    <description>handling assessment of the implant system by the surgeons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical procedure evaluation</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>assessment of the invasivity of the surgical procedure from the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 14</measure>
    <time_frame>14 days after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 1 month</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 2 months</measure>
    <time_frame>2 months after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 3 months</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 4 months</measure>
    <time_frame>4 months after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 5 months</measure>
    <time_frame>5 months after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 6 months</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 1 year</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 3 years</measure>
    <time_frame>3 years after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>implant stability 5 years</measure>
    <time_frame>5 years after surgery</time_frame>
    <description>resonance frequence analysis of the implant</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Alveolar Bone Loss</condition>
  <arm_group>
    <arm_group_label>narrow ridge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>wedge shape implants insertion</intervention_name>
    <description>Narrow dental implants inserted in narrow ridges</description>
    <arm_group_label>narrow ridge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. indications for prosthetic rehabilitation supported by implants in the upper or lower&#xD;
             arch, based on accurate diagnosis and treatment planning;&#xD;
&#xD;
          2. the bone crest must be completely healed (at least six months after the tooth loss);&#xD;
&#xD;
          3. residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction;&#xD;
&#xD;
          4. presence of at least 10 mm bone height available for implant placement;&#xD;
&#xD;
          5. age of the patient&gt; 18 years;&#xD;
&#xD;
          6. The patient must not carry any removable prosthesis on the treated area;&#xD;
&#xD;
          7. the patient must be able to follow the protocol of study;&#xD;
&#xD;
          8. informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. acute myocardial infarction over the last 2 months;&#xD;
&#xD;
          2. uncontrolled coagulation disorders;&#xD;
&#xD;
          3. unmanaged diabetes (HBA1c&gt; 7.5);&#xD;
&#xD;
          4. radiotherapy to the head area in the last 24 months;&#xD;
&#xD;
          5. immunocompromised, HIV positive or chemotherapy patients over the past 5 years;&#xD;
&#xD;
          6. present or past treatment with intravenous bisphosphonates;&#xD;
&#xD;
          7. psychological or psychiatric problems;&#xD;
&#xD;
          8. abuse of alcohol or drugs;&#xD;
&#xD;
          9. uncontrolled periodontal disease&#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>claudio stacchi, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Piezosurgery Academy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Piezosurgery Academy</name>
      <address>
        <city>Parma</city>
        <state>PR</state>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Chiapasco M, Zaniboni M. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:113-23. doi: 10.1111/j.1600-0501.2009.01781.x.</citation>
    <PMID>19663958</PMID>
  </reference>
  <reference>
    <citation>Danza M, Guidi R, Carinci F. Comparison between implants inserted into piezo split and unsplit alveolar crests. J Oral Maxillofac Surg. 2009 Nov;67(11):2460-5. doi: 10.1016/j.joms.2009.04.041.</citation>
    <PMID>19837318</PMID>
  </reference>
  <reference>
    <citation>Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.</citation>
    <PMID>12956475</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Piezosurgery Academy</investigator_affiliation>
    <investigator_full_name>Mr. Claudio Stacchi, DDS, MSc</investigator_full_name>
    <investigator_title>President of the Academy</investigator_title>
  </responsible_party>
  <keyword>wedge implants; atrophic bone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
  </condition_browse>
  <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/NCT03290729
org study id: REX_i
nct id: NCT03290729
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was designed as a multicentric prospective clinical trial to assess the clinical,
      biological and patient's perceived success of new wedge-shaped dental implants inserted in
      narrow ridges.
Due to the loss of dental elements, the bone crest undergoes a significant remodeling. Bone
      resorption begins immediately after dental extraction with a 40-60% reduction in horizontal
      and vertical direction of the alveolar ridge during the first 2 years. The most significant
      bone loss after tooth extraction occurs within the first 3 months, although modeling and
      remodeling of the alveoli have a great variability of time: bone structure and organization
      may not be complete even 24 weeks after dental extraction.

      It is now known that crestal remodeling is closely related to the disappearance of the bundle
      bone, which is more representative of the buccal appearance of the alveolus. Its
      disappearance, especially in thin periodontal biotopes, can lead to significant recessions of
      hard and soft tissues.

      Moreover, with a variable percentage, in many patients, crestal resorption continues over
      time due to a combination of factors involved: anatomical, metabolic and mechanical. Among
      these, the use of removable total or partial dentures can play an important role in
      accelerating the resurfacing process.

      With these premises, it is common to find patients with atrophic crests when processing plans
      that provide implant support prosthetic rehabilitation.

      A crestal bone thickness of at least 6 mm in the buco-lingual sense is considered sufficient
      to safely place a plant with a diameter of 4 mm. But when the width is lower, a variety of
      procedures and techniques have been proposed in literature that allow recreate the volumes
      needed for implant placement.

      Horizontal lifting techniques with bone blocks (autologous, alloplastic, xeno-graft), guided
      bone regeneration, crest expansion technique have demonstrated a good long-term
      predictability of the inserted devices. However, some negatives related to these techniques
      need to be considered, such as increased morbidity for the patient, demand for advanced
      surgical skills for the operator, increased treatment costs, and increased therapy times.

      Because of these observations, a new implant design has been proposed for specific use in
      narrow ridges. Its wedge shape and press-fit insertion make it possible to position it with a
      minimally invasive preparation of the implant site, performed with ultrasound technique.

      Therefore, the use of this implant could allow effective and minimally invasive treatment of
      narrow edentulous crests up to 4 mm, with significant benefits to the patient in terms of
      morbidity, treatment costs and time.

      Twelve clinical centers will treat patients with insertion of wedge-shaped implants in thin
      crests with a specific surgical protocol and clinical outcomes will be collected and
      analyzed.

      The chosen medical device will be the Rex Tissue Level implant System. For each implant
      inserted, the clinical parameters will be recorded up to 5 years after insertion.

      In addition, intermediate evaluations will be carried out at 1 year and 3 years after
      installation.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: multicenter single cohort prospective study
primary purpose: Treatment
masking: None (Open Label)
measure: implant survival rate
time frame: 1 year after surgery
description: health of the inserted implants
measure: surgical procedure evaluation
time frame: during surgery
description: handling assessment of the implant system by the surgeons
measure: surgical procedure evaluation
time frame: 1 hour after surgery
description: assessment of the invasivity of the surgical procedure from the patient
measure: implant stability 14
time frame: 14 days after surgery
description: resonance frequence analysis of the implant
measure: implant stability 1 month
time frame: 1 month after surgery
description: resonance frequence analysis of the implant
measure: implant stability 2 months
time frame: 2 months after surgery
description: resonance frequence analysis of the implant
measure: implant stability 3 months
time frame: 3 months after surgery
description: resonance frequence analysis of the implant
measure: implant stability 4 months
time frame: 4 months after surgery
description: resonance frequence analysis of the implant
measure: implant stability 5 months
time frame: 5 months after surgery
description: resonance frequence analysis of the implant
measure: implant stability 6 months
time frame: 6 months after surgery
description: resonance frequence analysis of the implant
measure: implant stability 1 year
time frame: 1 year after surgery
description: resonance frequence analysis of the implant
measure: implant stability 3 years
time frame: 3 years after surgery
description: resonance frequence analysis of the implant
measure: implant stability 5 years
time frame: 5 years after surgery
description: resonance frequence analysis of the implant
arm group label: narrow ridge
arm group type: Experimental
description: edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion
intervention type: Procedure
intervention name: wedge shape implants insertion
description: Narrow dental implants inserted in narrow ridges
arm group label: narrow ridge
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: claudio stacchi, Dr.
role: Principal Investigator
affiliation: Piezosurgery Academy
facility: 
country: Italy
citation: Chiapasco M, Zaniboni M. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:113-23. doi: 10.1111/j.1600-0501.2009.01781.x.
PMID: 19663958
citation: Danza M, Guidi R, Carinci F. Comparison between implants inserted into piezo split and unsplit alveolar crests. J Oral Maxillofac Surg. 2009 Nov;67(11):2460-5. doi: 10.1016/j.joms.2009.04.041.
PMID: 19837318
citation: Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
PMID: 12956475
responsible party type: Principal Investigator
investigator affiliation: International Piezosurgery Academy
investigator full name: Mr. Claudio Stacchi, DDS, MSc
investigator title: President of the Academy
mesh term: Alveolar Bone Loss
sharing ipd: No