<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/NCT04492111</url>
  </required_header>
  <id_info>
    <org_study_id>UniBari</org_study_id>
    <nct_id>NCT04492111</nct_id>
  </id_info>
  <brief_title>X-space Implants in Post-extraction Sites.</brief_title>
  <official_title>Bone Remodelling Around Implants With Different Macro-design Placed in Post Extraction Sockets: A CBCT Randomized Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bari</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bari</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>
      Several recent systematic reviews have highlighted how the macrodesign of dental implants can&#xD;
      influence stress distribution and biomechanical and biological behavior in implants&#xD;
      immediately inserted in post-extraction sites. Finite element analyzes have confirmed the&#xD;
      benefit of the inclination of the implant threads in reducing implant displacement in&#xD;
      post-extraction sites, increasing primary stability, and decreasing stress in contact with&#xD;
      the trabecular bone.&#xD;
&#xD;
      Other comparative studies have shown that the design of the threads of the implant does not&#xD;
      affect the distribution of stress in the surrounding bone.&#xD;
&#xD;
      In view of the need to evaluate the influence of implant macrodesign in the case of implants&#xD;
      inserted in post-extraction alveoli, this study will examine the clinical results of two&#xD;
      different types of implants with different macrodesigns, with the aim of providing scientific&#xD;
      evidence in this regard.&#xD;
&#xD;
      The present study will investigate through a randomized controlled trial the effect of thread&#xD;
      macrodesign of X-space implants on primary stability and osseointegration when inserted in&#xD;
      post-extraction sites, as compared to cylindric 2P implants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives Evaluate the clinical and radiological performance of a new implant geometry&#xD;
      (X-space) with a central and apical thread designed to increase the contact surface with the&#xD;
      alveolar bone and allow a greater insertion torque and better primary stability in&#xD;
      post-extraction implants.&#xD;
&#xD;
      The evaluation will be done through:&#xD;
&#xD;
        -  Estimation of the difference in terms of dimensional changes of the alveolar bone&#xD;
           between the following implants placed in fresh post-extraction sites: (1) X-space (test&#xD;
           group), (2) Bone System 2P (control group)&#xD;
&#xD;
        -  Estimation of primary stability&#xD;
&#xD;
        -  Estimation of implant failure&#xD;
&#xD;
        -  Estimation of influences of different clinical factors implant and patient-related to&#xD;
           the values of the outcomes.&#xD;
&#xD;
      Expected results The null hypothesis is that the X-space implant is better than the 2P&#xD;
      implant. Even in the event of non-statistical significance, factors concerning clinical&#xD;
      significance and secondary variables will be assessed in order to determine the efficiency of&#xD;
      each of the treatments.&#xD;
&#xD;
      MATERIALS AND METHODS Study design The study will be a randomized clinical trial with two&#xD;
      arms, each arm belonging to one of the two intervention groups. The randomization sequence&#xD;
      will be computer-generated by an independent statistical specialist.&#xD;
&#xD;
      All the interventions will be performed at the same center by 3 different clinicans following&#xD;
      the same protocol. Surgeons will be aware of the type of intervention to be performed only&#xD;
      after tooth extraction, therefore immediately before performing the intervention of interest.&#xD;
&#xD;
      The type of intervention will be assigned by means of sealed opaque envelopes that will be&#xD;
      open immediately before the intervention.&#xD;
&#xD;
      Patients will be provided with adequate and exhaustive information for participation in the&#xD;
      study and each patient must sign a detailed informed consent.&#xD;
&#xD;
      All the interventions performed and the procedures followed in this study are in accordance&#xD;
      with the ethical standards of the committee responsible for human experimentation&#xD;
      (institutional and national) and with the Helsinki Declaration of 1975, revised in 2000.&#xD;
&#xD;
      Sample size The sample size was determined for a first type error (alpha) 0.05 and a study&#xD;
      power of 0.9 (beta 0.1). The reference variable is the dimensional change of the thickness of&#xD;
      the vestibular crest (measured at the implant platform level).&#xD;
&#xD;
      The minimal effect of interest assessed from previous studies and the researchers' clinical&#xD;
      evaluation was established at 1 mm, while the standard deviation was 0.6 mm.&#xD;
&#xD;
      Considering a 20% loss at follow-up, the sample size required for each group was determined&#xD;
      at 15 participants, or 30 participants in all.&#xD;
&#xD;
      References:&#xD;
&#xD;
      1. Wittes J. Sample size calculation for randomized controlled trials. Epidemiol Rev. Vol 24,&#xD;
      No. 1, 2002.&#xD;
&#xD;
      Procedures foreseen by the study Thirty implants (15 X-Space and 15 Bone System Cylindrical&#xD;
      &quot;2P&quot;) of variable diameter and of adequate length will be immediately inserted in the&#xD;
      post-extraction sites of thirty patients with therapeutic indications for implantation. The&#xD;
      implants (Bone System, Milan) are produced on machining centers and subjected to rigorous&#xD;
      cleaning treatments and high precision dimensional checks.&#xD;
&#xD;
      The Ecotek surface of the Bone System implants boasts a long experience of 25 years of&#xD;
      clinical applications, Implant surface treatment is obtained by sandblasting with ruby&#xD;
      corundum and subsequent etching treatment with acids.&#xD;
&#xD;
      • Surgical protocol In all cases, the extractions will be carried out without lifting the&#xD;
      flap and preserving the vestibular wall of the alveolus.&#xD;
&#xD;
      All implants will be inserted at the crest level and will be closed by a screw. The surgical&#xD;
      procedure requires insertion into the implant tunnel by means of a controlled torque&#xD;
      micromotor (max 50 Ncm), at a speed of 20/25 rpm; for this purpose it is necessary to have a&#xD;
      special driver (40120701) inserted in the contra-angle handpiece; for manual insertion with&#xD;
      controlled torque, a dynamometric ratchet (CRD) with the relative short (40052401) and&#xD;
      standard (40052501) drivers are available.&#xD;
&#xD;
      However, the possibility of insertion with a manual screwdriver is maintained, with the usual&#xD;
      tools already used for the other Bone System implants.&#xD;
&#xD;
      The post-extraction site will be closed with a collagen membrane and cross suture.&#xD;
&#xD;
      Data collection methods Variables to be measured (outcomes) Patients will undergo a CT Cone&#xD;
      Beam examination immediately after implant insertion and 6 months later to evaluate the&#xD;
      morphological and dimensional changes of the alveolar bone horizontally and vertically around&#xD;
      the tooth / implant. All the measurements will be carried out in a computerized program which&#xD;
      will allow to standardize the repeated measurements.&#xD;
&#xD;
      The measurements on the CT Cone Beam exams and the measurements of the secondary variables&#xD;
      will be carried out by an operator not aware of the group to which the patients belong (blind&#xD;
      examiner).&#xD;
&#xD;
      Criteria for stopping the study&#xD;
&#xD;
        -  Observation of high difference between the techniques, indicating one technique as more&#xD;
           efficient than the others or a technique as much less efficient than the other (ethical&#xD;
           reason).&#xD;
&#xD;
        -  High number of patients lost at follow-up (greater than expected when calculating the&#xD;
           sample size).&#xD;
&#xD;
      Criteria for the exit of the subject from the study&#xD;
&#xD;
        -  Missing presence at the control at 1 and 3 months (for general evaluation and oral&#xD;
           hygiene control)&#xD;
&#xD;
        -  Missed presence at check and measures at 6 months&#xD;
&#xD;
        -  Lack of collaboration at the oral hygiene level (oral hygiene assessment indices)&#xD;
&#xD;
        -  Ongoing presence of periodontal diseases or oral mucous membranes. Ongoing presence of&#xD;
           systemic diseases (or related medical therapies) that may influence bone metabolism and&#xD;
           tissue healing (e.g. Osteoporosis, corticosteroid therapy, immunodepressive therapies,&#xD;
           chemotherapy, radiotherapy, etc.).&#xD;
&#xD;
      Expected duration The foreseeable duration of this study is 18-24 months.&#xD;
&#xD;
      Statistical data analysis The statistical analyzes will be carried out by a statistical&#xD;
      analysis expert, on coded and non-identifiable groups. The statistical unit will be the&#xD;
      patient.&#xD;
&#xD;
      Descriptive analyzes will be conducted for all demographic variables at the beginning and end&#xD;
      of therapy. Mann-Whitney test will be used for statistical comparison analyzes of continuous&#xD;
      variables between independent groups. In addition, several multilevel regression analyzes&#xD;
      will be conducted to assess the dependence of bone changes on the initial thickness of the&#xD;
      vestibular wall and on various patient-related variables. For statistical tests the p-value&#xD;
      will be established at 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 2, 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>Randomized clinical trial of parallel design with a 1:1 allocation ratio</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Patient not aware of the type of implant. Investigator of clinical conditions not aware of the type of implant.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Buccal bone dimensional changes</measure>
    <time_frame>6 months</time_frame>
    <description>Measurements of buccal bone dimensional changes assessed through a series of linear measurements on two cone-beam (immediately after implant insertion and after 6 months). Measurements will be calibrated using the implant as a reference and will be performed at the marginal bone level, at the central spire level and at the apex level. Outcome will be expressed in mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implant failure</measure>
    <time_frame>6 months</time_frame>
    <description>Dental implant loss after insertion. Outcome will be assessed during follow-up checks and confirmed through clinical signs of loss (implant mobility) and intraoral radiograph.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary stability</measure>
    <time_frame>immediately after implant insertion</time_frame>
    <description>Measurement of primary stability immediately after implant insertion through Osttell Mentor and expressed as implant stability quotient (ISQ)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications</measure>
    <time_frame>During the entire follow-up period- up to 6 months.</time_frame>
    <description>Complications during and after implant insertion assessed by patient referral and during clinical checks.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Missing Tooth</condition>
  <condition>Osseointegration Failure of Dental Implant</condition>
  <arm_group>
    <arm_group_label>X-space group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient of the experimental group will receive one X-space implant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2P group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each patient of the control group will receive one 2P implant. Bone System Cylindric implants. Surface Ecotek.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>post-extraction dental implant</intervention_name>
    <description>Insertion of a dental implant immediately after tooth extraction.</description>
    <arm_group_label>2P group</arm_group_label>
    <arm_group_label>X-space group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Absence of systemic or local diseases that could compromise implant or prosthetic&#xD;
             therapy&#xD;
&#xD;
          -  Good periodontal health, assessed by periodontal indices&#xD;
&#xD;
          -  Presence of premolar / canine / incisor teeth and with extraction indications and with&#xD;
             the presence of two adjacent natural teeth.&#xD;
&#xD;
          -  Absence of probing greater than 4mm in the vestibular wall of the crestal bone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CT scan performed in the last 5 years&#xD;
&#xD;
          -  Active periodontal diseases&#xD;
&#xD;
          -  Heavy smokers (more than 20 cigarettes per day)&#xD;
&#xD;
          -  Consumers of high alcohol levels&#xD;
&#xD;
          -  Therapy with corticosteroids, immunosuppressive therapies, chemotherapy, radiotherapy,&#xD;
             pregnancy&#xD;
&#xD;
          -  Lack of collaboration for continuous post-intervention re-evaluations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felice Roberto Grassi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bari</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aldo Moro University</name>
      <address>
        <city>Bari</city>
        <zip>70121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Lima de Andrade C, Carvalho MA, Bordin D, da Silva WJ, Del Bel Cury AA, Sotto-Maior BS. Biomechanical Behavior of the Dental Implant Macrodesign. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):264-270. doi: 10.11607/jomi.4797.</citation>
    <PMID>28291847</PMID>
  </reference>
  <reference>
    <citation>Cali M, Zanetti EM, Oliveri SM, Asero R, Ciaramella S, Martorelli M, Bignardi C. Influence of thread shape and inclination on the biomechanical behaviour of plateau implant systems. Dent Mater. 2018 Mar;34(3):460-469. doi: 10.1016/j.dental.2018.01.012. Epub 2018 Feb 1.</citation>
    <PMID>29395470</PMID>
  </reference>
  <reference>
    <citation>Grassi FR, Grassi R, Rapone B, Alemanno G, Balena A, Kalemaj Z. Dimensional changes of buccal bone plate in immediate implants inserted through open flap, open flap and bone grafting and flapless techniques: A cone-beam computed tomography randomized controlled clinical trial. Clin Oral Implants Res. 2019 Dec;30(12):1155-1164. doi: 10.1111/clr.13528. Epub 2019 Sep 11.</citation>
    <PMID>31461183</PMID>
  </reference>
  <results_reference>
    <citation>Scarano A, Assenza B, Inchingolo F, Mastrangelo F, Lorusso F. New Implant Design with Midcrestal and Apical Wing Thread for Increased Implant Stability in Single Postextraction Maxillary Implant. Case Rep Dent. 2019 Sep 5;2019:9529248. doi: 10.1155/2019/9529248. eCollection 2019.</citation>
    <PMID>31583139</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bari</investigator_affiliation>
    <investigator_full_name>Felice Roberto Grassi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>primary stability</keyword>
  <keyword>dental implant</keyword>
  <keyword>post-extraction dental implant</keyword>
  <keyword>dental implant macrodesign</keyword>
  <keyword>implant failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</mesh_term>
    <mesh_term>Anodontia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD will be shared with researchers who make an official request</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/NCT04492111
org study id: UniBari
nct id: NCT04492111
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Several recent systematic reviews have highlighted how the macrodesign of dental implants can
      influence stress distribution and biomechanical and biological behavior in implants
      immediately inserted in post-extraction sites. Finite element analyzes have confirmed the
      benefit of the inclination of the implant threads in reducing implant displacement in
      post-extraction sites, increasing primary stability, and decreasing stress in contact with
      the trabecular bone.

      Other comparative studies have shown that the design of the threads of the implant does not
      affect the distribution of stress in the surrounding bone.

      In view of the need to evaluate the influence of implant macrodesign in the case of implants
      inserted in post-extraction alveoli, this study will examine the clinical results of two
      different types of implants with different macrodesigns, with the aim of providing scientific
      evidence in this regard.

      The present study will investigate through a randomized controlled trial the effect of thread
      macrodesign of X-space implants on primary stability and osseointegration when inserted in
      post-extraction sites, as compared to cylindric 2P implants.
Objectives Evaluate the clinical and radiological performance of a new implant geometry
      (X-space) with a central and apical thread designed to increase the contact surface with the
      alveolar bone and allow a greater insertion torque and better primary stability in
      post-extraction implants.

      The evaluation will be done through:

        -  Estimation of the difference in terms of dimensional changes of the alveolar bone
           between the following implants placed in fresh post-extraction sites: (1) X-space (test
           group), (2) Bone System 2P (control group)

        -  Estimation of primary stability

        -  Estimation of implant failure

        -  Estimation of influences of different clinical factors implant and patient-related to
           the values of the outcomes.

      Expected results The null hypothesis is that the X-space implant is better than the 2P
      implant. Even in the event of non-statistical significance, factors concerning clinical
      significance and secondary variables will be assessed in order to determine the efficiency of
      each of the treatments.

      MATERIALS AND METHODS Study design The study will be a randomized clinical trial with two
      arms, each arm belonging to one of the two intervention groups. The randomization sequence
      will be computer-generated by an independent statistical specialist.

      All the interventions will be performed at the same center by 3 different clinicans following
      the same protocol. Surgeons will be aware of the type of intervention to be performed only
      after tooth extraction, therefore immediately before performing the intervention of interest.

      The type of intervention will be assigned by means of sealed opaque envelopes that will be
      open immediately before the intervention.

      Patients will be provided with adequate and exhaustive information for participation in the
      study and each patient must sign a detailed informed consent.

      All the interventions performed and the procedures followed in this study are in accordance
      with the ethical standards of the committee responsible for human experimentation
      (institutional and national) and with the Helsinki Declaration of 1975, revised in 2000.

      Sample size The sample size was determined for a first type error (alpha) 0.05 and a study
      power of 0.9 (beta 0.1). The reference variable is the dimensional change of the thickness of
      the vestibular crest (measured at the implant platform level).

      The minimal effect of interest assessed from previous studies and the researchers' clinical
      evaluation was established at 1 mm, while the standard deviation was 0.6 mm.

      Considering a 20% loss at follow-up, the sample size required for each group was determined
      at 15 participants, or 30 participants in all.

      References:

      1. Wittes J. Sample size calculation for randomized controlled trials. Epidemiol Rev. Vol 24,
      No. 1, 2002.

      Procedures foreseen by the study Thirty implants (15 X-Space and 15 Bone System Cylindrical
      "2P") of variable diameter and of adequate length will be immediately inserted in the
      post-extraction sites of thirty patients with therapeutic indications for implantation. The
      implants (Bone System, Milan) are produced on machining centers and subjected to rigorous
      cleaning treatments and high precision dimensional checks.

      The Ecotek surface of the Bone System implants boasts a long experience of 25 years of
      clinical applications, Implant surface treatment is obtained by sandblasting with ruby
      corundum and subsequent etching treatment with acids.

      • Surgical protocol In all cases, the extractions will be carried out without lifting the
      flap and preserving the vestibular wall of the alveolus.

      All implants will be inserted at the crest level and will be closed by a screw. The surgical
      procedure requires insertion into the implant tunnel by means of a controlled torque
      micromotor (max 50 Ncm), at a speed of 20/25 rpm; for this purpose it is necessary to have a
      special driver (40120701) inserted in the contra-angle handpiece; for manual insertion with
      controlled torque, a dynamometric ratchet (CRD) with the relative short (40052401) and
      standard (40052501) drivers are available.

      However, the possibility of insertion with a manual screwdriver is maintained, with the usual
      tools already used for the other Bone System implants.

      The post-extraction site will be closed with a collagen membrane and cross suture.

      Data collection methods Variables to be measured (outcomes) Patients will undergo a CT Cone
      Beam examination immediately after implant insertion and 6 months later to evaluate the
      morphological and dimensional changes of the alveolar bone horizontally and vertically around
      the tooth / implant. All the measurements will be carried out in a computerized program which
      will allow to standardize the repeated measurements.

      The measurements on the CT Cone Beam exams and the measurements of the secondary variables
      will be carried out by an operator not aware of the group to which the patients belong (blind
      examiner).

      Criteria for stopping the study

        -  Observation of high difference between the techniques, indicating one technique as more
           efficient than the others or a technique as much less efficient than the other (ethical
           reason).

        -  High number of patients lost at follow-up (greater than expected when calculating the
           sample size).

      Criteria for the exit of the subject from the study

        -  Missing presence at the control at 1 and 3 months (for general evaluation and oral
           hygiene control)

        -  Missed presence at check and measures at 6 months

        -  Lack of collaboration at the oral hygiene level (oral hygiene assessment indices)

        -  Ongoing presence of periodontal diseases or oral mucous membranes. Ongoing presence of
           systemic diseases (or related medical therapies) that may influence bone metabolism and
           tissue healing (e.g. Osteoporosis, corticosteroid therapy, immunodepressive therapies,
           chemotherapy, radiotherapy, etc.).

      Expected duration The foreseeable duration of this study is 18-24 months.

      Statistical data analysis The statistical analyzes will be carried out by a statistical
      analysis expert, on coded and non-identifiable groups. The statistical unit will be the
      patient.

      Descriptive analyzes will be conducted for all demographic variables at the beginning and end
      of therapy. Mann-Whitney test will be used for statistical comparison analyzes of continuous
      variables between independent groups. In addition, several multilevel regression analyzes
      will be conducted to assess the dependence of bone changes on the initial thickness of the
      vestibular wall and on various patient-related variables. For statistical tests the p-value
      will be established at 0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial of parallel design with a 1:1 allocation ratio
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Patient not aware of the type of implant. Investigator of clinical conditions not aware of the type of implant.
measure: Buccal bone dimensional changes
time frame: 6 months
description: Measurements of buccal bone dimensional changes assessed through a series of linear measurements on two cone-beam (immediately after implant insertion and after 6 months). Measurements will be calibrated using the implant as a reference and will be performed at the marginal bone level, at the central spire level and at the apex level. Outcome will be expressed in mm.
measure: Implant failure
time frame: 6 months
description: Dental implant loss after insertion. Outcome will be assessed during follow-up checks and confirmed through clinical signs of loss (implant mobility) and intraoral radiograph.
measure: Primary stability
time frame: immediately after implant insertion
description: Measurement of primary stability immediately after implant insertion through Osttell Mentor and expressed as implant stability quotient (ISQ)
measure: Complications
time frame: During the entire follow-up period- up to 6 months.
description: Complications during and after implant insertion assessed by patient referral and during clinical checks.
arm group label: X-space group
arm group type: Experimental
description: Each patient of the experimental group will receive one X-space implant.
arm group label: 2P group
arm group type: Active Comparator
description: Each patient of the control group will receive one 2P implant. Bone System Cylindric implants. Surface Ecotek.
intervention type: Procedure
intervention name: post-extraction dental implant
description: Insertion of a dental implant immediately after tooth extraction.
arm group label: 2P group
arm group label: X-space group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Felice Roberto Grassi, PhD
role: Principal Investigator
affiliation: University of Bari
facility: 
country: Italy
citation: Lima de Andrade C, Carvalho MA, Bordin D, da Silva WJ, Del Bel Cury AA, Sotto-Maior BS. Biomechanical Behavior of the Dental Implant Macrodesign. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):264-270. doi: 10.11607/jomi.4797.
PMID: 28291847
citation: Cali M, Zanetti EM, Oliveri SM, Asero R, Ciaramella S, Martorelli M, Bignardi C. Influence of thread shape and inclination on the biomechanical behaviour of plateau implant systems. Dent Mater. 2018 Mar;34(3):460-469. doi: 10.1016/j.dental.2018.01.012. Epub 2018 Feb 1.
PMID: 29395470
citation: Grassi FR, Grassi R, Rapone B, Alemanno G, Balena A, Kalemaj Z. Dimensional changes of buccal bone plate in immediate implants inserted through open flap, open flap and bone grafting and flapless techniques: A cone-beam computed tomography randomized controlled clinical trial. Clin Oral Implants Res. 2019 Dec;30(12):1155-1164. doi: 10.1111/clr.13528. Epub 2019 Sep 11.
PMID: 31461183
citation: Scarano A, Assenza B, Inchingolo F, Mastrangelo F, Lorusso F. New Implant Design with Midcrestal and Apical Wing Thread for Increased Implant Stability in Single Postextraction Maxillary Implant. Case Rep Dent. 2019 Sep 5;2019:9529248. doi: 10.1155/2019/9529248. eCollection 2019.
PMID: 31583139
responsible party type: Principal Investigator
investigator affiliation: University of Bari
investigator full name: Felice Roberto Grassi
investigator title: Professor
mesh term: Tooth Loss
mesh term: Anodontia
sharing ipd: Undecided
ipd description: IPD will be shared with researchers who make an official request