<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/NCT04480073</url>
  </required_header>
  <id_info>
    <org_study_id>MChiapasco</org_study_id>
    <nct_id>NCT04480073</nct_id>
  </id_info>
  <brief_title>Guided Bone Regeneration With Customized Titanium Meshes</brief_title>
  <official_title>Customized CAD/CAM Titanium Meshes for the Guided Bone Regeneration of Severe Alveolar Ridge Defects: Preliminary Results of a Prospective Clinical Follow-up Study in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Milan</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>
      The aims of this prospective clinical study are to evaluate: a) the effectiveness of&#xD;
      digitally customized titanium meshes in association with autologous bone particles and bovine&#xD;
      bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous&#xD;
      sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone&#xD;
      regeneration from a histomorphometric point of view&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        -  to evaluate the effectiveness of digitally customized titanium meshes for guided bone&#xD;
           regeneration with autologous bone chips taken from the mandibular body and/or ramus&#xD;
           mixed with bovine bone mineral bone granules (500-1000microns in diameter):&#xD;
&#xD;
             -  complication rate of the reconstructive procedure;&#xD;
&#xD;
             -  assessment of bone gain obtained before implant placement;&#xD;
&#xD;
        -  implant survival and implant-related complications 1 year after the starting of&#xD;
           prosthetic loading;&#xD;
&#xD;
        -  peri-implant bone resorption (MBL) after 1 year from the prosthetic load.&#xD;
&#xD;
        -  to perform a histomorphometric analysis of bone samples taken from sites reconstructed&#xD;
           according to the principle of Guided Bone regeneration by means of autologous bone chips&#xD;
           mixed with a xenograft with a 1:1 ratio and customized titanium mesh.&#xD;
&#xD;
      The following parameters will be analyzed from an histologic point of view:&#xD;
&#xD;
        -  bone remodeling and mineralization levels of the new bone matrix&#xD;
&#xD;
        -  volumetric tissue fractions&#xD;
&#xD;
        -  neo-vascularization&#xD;
&#xD;
      Study method: prospective study - 24 consecutive patients treated (see statistical power&#xD;
      analysis)&#xD;
&#xD;
      The study will be performed in accordance with the ISO Standard 14155: 2011, Clinical&#xD;
      Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the&#xD;
      Medical Device Directive 93/42/ EEC and following the 2004 Helsinki Declaration.&#xD;
&#xD;
      The null hypothesis (H0) is the following: the reconstructed bone is not functionally mature&#xD;
      to support implants, masticatory and functional loads after 12 months.&#xD;
&#xD;
      The sample size calculation was performed with the statistical program&#xD;
      https://clincalc.com/stats/samplesize.aspx. A literature search on PubMed was performed and&#xD;
      revealed that, on average, the percentage of new bone formed after reconstructions with&#xD;
      particulate bone autografts and xenografts and titanium mesh is 66% with a standard deviation&#xD;
      of 6%. The expected percentage value for the investigator's study was set at 70% with a&#xD;
      statistical power of 90% and a two-tier significance level of 0.05.&#xD;
&#xD;
      Data distribution will be analyzed by Shapiro Wilk's normality test, due to the small sample&#xD;
      size.&#xD;
&#xD;
      If the data distribution is normal, the comparative analysis for the primary outcome will be&#xD;
      performed by T-student test for paired samples. If the data distribution is not normal, a&#xD;
      Wilcoxon test will be performed.&#xD;
&#xD;
      The independent variable of the study is the bone reconstruction procedure. The dependent&#xD;
      variables are: a) the histomorphometric values of the reconstructed bone; b) the increase&#xD;
      (measured in mm) of the bone reconstruction obtained; c) the MBL (in mm) peri-implant 1 year&#xD;
      after the prosthetic load.&#xD;
&#xD;
      Data analysis will be performed with SPSS software. Differences will be considered&#xD;
      statistically significant for alpha &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels</measure>
    <time_frame>6-9 months</time_frame>
    <description>Samples will be processed following a standardized protocol for hard tissues.&#xD;
Bone remodeling and mineralization levels of the new bone matrix (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions</measure>
    <time_frame>6-9 months</time_frame>
    <description>Samples will be processed following a standardized protocol for hard tissues.&#xD;
Volumetric tissue fractions (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization</measure>
    <time_frame>6-9 months</time_frame>
    <description>Samples will be processed following a standardized protocol for hard tissues.&#xD;
Neo-vascularization (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure</measure>
    <time_frame>6-9 months</time_frame>
    <description>Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain</measure>
    <time_frame>6-9 months</time_frame>
    <description>Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival</measure>
    <time_frame>12 months</time_frame>
    <description>Implant survival (expressed in percentage) will be analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption</measure>
    <time_frame>6-9 months</time_frame>
    <description>Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Bone Resorption</condition>
  <arm_group>
    <arm_group_label>edentulous patients with atrophic jaws</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients presenting with severely atrophic edentulous sites in the upper and lower jaw, and requesting implant-supported prosthetic restorations, will be enrolled in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges</intervention_name>
    <description>Step one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws.&#xD;
A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls.&#xD;
6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement.&#xD;
Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement.&#xD;
3 months later, implants will be uncovered and the prosthetic phases will start.&#xD;
Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications.</description>
    <arm_group_label>edentulous patients with atrophic jaws</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  systemically healthy patients;&#xD;
&#xD;
          -  a minimum age of 18 years;&#xD;
&#xD;
          -  relevant or severe bone atrophy at the edentulous sites incompatible with placement of&#xD;
             even short (≤6 mm) or narrow (&lt;3 mm) implants in an appropriate and prosthetically&#xD;
             guided position;&#xD;
&#xD;
          -  adequate compliance of patients, both in terms of oral hygiene and respect the&#xD;
             follow-up recalls;&#xD;
&#xD;
          -  ability to understand the proposed surgical treatment and to understand and sign the&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe kidney and/or liver disease;&#xD;
&#xD;
          -  congenital or acquired immunodeficiency;&#xD;
&#xD;
          -  ongoing antiblastic chemotherapy at the time of first examination;&#xD;
&#xD;
          -  sequelae of radiotherapy in the head and neck area;&#xD;
&#xD;
          -  oral mucosa diseases, such as lichen planus;&#xD;
&#xD;
          -  full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) &lt; 20%;&#xD;
&#xD;
          -  non-compliant patients;&#xD;
&#xD;
          -  tobacco abuse (&gt;10 cigarettes per day) or alcohol abuse;&#xD;
&#xD;
          -  non compensated diabetes;&#xD;
&#xD;
          -  active periodontal disease at the time of first examination ;&#xD;
&#xD;
          -  bisphosphonate chemotherapy in progress;&#xD;
&#xD;
          -  pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matteo Chiapasco, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Biomedical, Surgical and Dental Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matteo Chiapasco, Professor</last_name>
    <phone>+390250319000</phone>
    <email>matteo.chiapasco@unimi.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>ASST Santi Paolo e Carlo</name>
      <address>
        <city>Milan</city>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matteo Chiapasco, Professor</last_name>
      <email>matteo.chiapasco@unimi.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Sagheb K, Schiegnitz E, Moergel M, Walter C, Al-Nawas B, Wagner W. Clinical outcome of alveolar ridge augmentation with individualized CAD-CAM-produced titanium mesh. Int J Implant Dent. 2017 Dec;3(1):36. doi: 10.1186/s40729-017-0097-z. Epub 2017 Jul 26.</citation>
    <PMID>28748521</PMID>
  </results_reference>
  <results_reference>
    <citation>Seiler M, Kammerer PW, Peetz M, Hartmann A. Customized lattice structure in reconstruction of three-dimensional alveolar defects. Int J Comput Dent. 2018;21(3):261-267.</citation>
    <PMID>30264055</PMID>
  </results_reference>
  <results_reference>
    <citation>Sumida T, Otawa N, Kamata YU, Kamakura S, Mtsushita T, Kitagaki H, Mori S, Sasaki K, Fujibayashi S, Takemoto M, Yamaguchi A, Sohmura T, Nakamura T, Mori Y. Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh. J Craniomaxillofac Surg. 2015 Dec;43(10):2183-8. doi: 10.1016/j.jcms.2015.10.020. Epub 2015 Oct 23.</citation>
    <PMID>26603108</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Milan</investigator_affiliation>
    <investigator_full_name>Prof. Matto Chiapasco</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>guided bone regeneration</keyword>
  <keyword>dental implants</keyword>
  <keyword>alveolar bone defects</keyword>
  <keyword>custom-made</keyword>
  <keyword>Titanium mesh</keyword>
  <keyword>CAD-CAM</keyword>
  <keyword>implant-supported prosthesis</keyword>
  <keyword>autogenous bone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>collecting data to verify the effectiveness of bone regeneration with customized titanium meshes and publication of results on peer-reviewed international journals</ipd_description>
  </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/NCT04480073
org study id: MChiapasco
nct id: NCT04480073
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aims of this prospective clinical study are to evaluate: a) the effectiveness of
      digitally customized titanium meshes in association with autologous bone particles and bovine
      bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous
      sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone
      regeneration from a histomorphometric point of view
Objectives:

        -  to evaluate the effectiveness of digitally customized titanium meshes for guided bone
           regeneration with autologous bone chips taken from the mandibular body and/or ramus
           mixed with bovine bone mineral bone granules (500-1000microns in diameter):

             -  complication rate of the reconstructive procedure;

             -  assessment of bone gain obtained before implant placement;

        -  implant survival and implant-related complications 1 year after the starting of
           prosthetic loading;

        -  peri-implant bone resorption (MBL) after 1 year from the prosthetic load.

        -  to perform a histomorphometric analysis of bone samples taken from sites reconstructed
           according to the principle of Guided Bone regeneration by means of autologous bone chips
           mixed with a xenograft with a 1:1 ratio and customized titanium mesh.

      The following parameters will be analyzed from an histologic point of view:

        -  bone remodeling and mineralization levels of the new bone matrix

        -  volumetric tissue fractions

        -  neo-vascularization

      Study method: prospective study - 24 consecutive patients treated (see statistical power
      analysis)

      The study will be performed in accordance with the ISO Standard 14155: 2011, Clinical
      Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the
      Medical Device Directive 93/42/ EEC and following the 2004 Helsinki Declaration.

      The null hypothesis (H0) is the following: the reconstructed bone is not functionally mature
      to support implants, masticatory and functional loads after 12 months.

      The sample size calculation was performed with the statistical program
      https://clincalc.com/stats/samplesize.aspx. A literature search on PubMed was performed and
      revealed that, on average, the percentage of new bone formed after reconstructions with
      particulate bone autografts and xenografts and titanium mesh is 66% with a standard deviation
      of 6%. The expected percentage value for the investigator's study was set at 70% with a
      statistical power of 90% and a two-tier significance level of 0.05.

      Data distribution will be analyzed by Shapiro Wilk's normality test, due to the small sample
      size.

      If the data distribution is normal, the comparative analysis for the primary outcome will be
      performed by T-student test for paired samples. If the data distribution is not normal, a
      Wilcoxon test will be performed.

      The independent variable of the study is the bone reconstruction procedure. The dependent
      variables are: a) the histomorphometric values of the reconstructed bone; b) the increase
      (measured in mm) of the bone reconstruction obtained; c) the MBL (in mm) peri-implant 1 year
      after the prosthetic load.

      Data analysis will be performed with SPSS software. Differences will be considered
      statistically significant for alpha <0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
time frame: 6-9 months
description: Samples will be processed following a standardized protocol for hard tissues.
Bone remodeling and mineralization levels of the new bone matrix (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
measure: Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions
time frame: 6-9 months
description: Samples will be processed following a standardized protocol for hard tissues.
Volumetric tissue fractions (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
measure: Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization
time frame: 6-9 months
description: Samples will be processed following a standardized protocol for hard tissues.
Neo-vascularization (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
measure: Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure
time frame: 6-9 months
description: Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed
measure: Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain
time frame: 6-9 months
description: Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed
measure: Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival
time frame: 12 months
description: Implant survival (expressed in percentage) will be analyzed
measure: Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications
time frame: 12 months
description: Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed
measure: Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption
time frame: 6-9 months
description: Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed
arm group label: edentulous patients with atrophic jaws
arm group type: Other
description: patients presenting with severely atrophic edentulous sites in the upper and lower jaw, and requesting implant-supported prosthetic restorations, will be enrolled in this study.
intervention type: Procedure
intervention name: Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges
description: Step one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws.
A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls.
6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement.
Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement.
3 months later, implants will be uncovered and the prosthetic phases will start.
Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications.
arm group label: edentulous patients with atrophic jaws
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matteo Chiapasco, Professor
role: Principal Investigator
affiliation: Department of Biomedical, Surgical and Dental Sciences
last name: Matteo Chiapasco, Professor
phone: +390250319000
email: matteo.chiapasco@unimi.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Sagheb K, Schiegnitz E, Moergel M, Walter C, Al-Nawas B, Wagner W. Clinical outcome of alveolar ridge augmentation with individualized CAD-CAM-produced titanium mesh. Int J Implant Dent. 2017 Dec;3(1):36. doi: 10.1186/s40729-017-0097-z. Epub 2017 Jul 26.
PMID: 28748521
citation: Seiler M, Kammerer PW, Peetz M, Hartmann A. Customized lattice structure in reconstruction of three-dimensional alveolar defects. Int J Comput Dent. 2018;21(3):261-267.
PMID: 30264055
citation: Sumida T, Otawa N, Kamata YU, Kamakura S, Mtsushita T, Kitagaki H, Mori S, Sasaki K, Fujibayashi S, Takemoto M, Yamaguchi A, Sohmura T, Nakamura T, Mori Y. Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh. J Craniomaxillofac Surg. 2015 Dec;43(10):2183-8. doi: 10.1016/j.jcms.2015.10.020. Epub 2015 Oct 23.
PMID: 26603108
responsible party type: Principal Investigator
investigator affiliation: University of Milan
investigator full name: Prof. Matto Chiapasco
investigator title: Professor
mesh term: Bone Resorption
sharing ipd: No
ipd description: collecting data to verify the effectiveness of bone regeneration with customized titanium meshes and publication of results on peer-reviewed international journals