xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05975138</url>
    </required_header>
    <id_info>
      <org_study_id>M2TRANS-SUB</org_study_id>
      <nct_id>NCT05975138</nct_id>
    </id_info>
    <brief_title>Trans-gingival or Subcrestal Short Implants Posterior Maxilla Bone Changes</brief_title>
    <official_title>Marginal Bone Level Changes in Trans-gingival or Subcrestal Level Short Implants in the Atrophic Posterior Maxilla.</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>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>
        two groups of inserted implants: trans-gingival and under-bone level; difference in the&#xD;
        marginal bone loss at six months from placement between the two groups of implant positioned&#xD;
        in the posterior atrophic maxilla&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The inserted implants will be divided into two groups (group A: trans-gingival implants;&#xD;
        group B: under bone level implants): a sample of 17 implants for each group was calculated to&#xD;
        be necessary to detect a statistically significant difference in the marginal bone loss at&#xD;
        six months from placement between the two groups (primary outcome) (alpha level set at 0.05&#xD;
        and statistical power at 80%) (Primer 6.0, Mc Graw-Hill, USA). The expected differences in&#xD;
        marginal bone loss between groups (0.1 ±0.1 mm) were extrapolated from literature studies&#xD;
        conducted on the topic10. Each center will treat 15 patients who need to insert implants in&#xD;
        the posterior maxillary area, for a total of 45 implants, in order to compensate for any&#xD;
        drop-outs.&#xD;
  &#xD;
        Training and calibration session. Before the start of the study, a meeting will be held&#xD;
        between all clinical centers to explain the surgical protocol, in order to ensure that&#xD;
        clinical operators apply a standardized approach. A clinical operator for each center will&#xD;
        receive written instructions regarding the evaluation of the experimental parameters in order&#xD;
        to obtain repeatability in the collection of clinical parameters and in the compilation of&#xD;
        the Case Report Form.&#xD;
  &#xD;
        Screening stage.&#xD;
  &#xD;
        All patients treated by the Clinical Centers are eligible to enter this study. Prior to&#xD;
        enrollment, all patients will be required to sign an informed consent form to document that&#xD;
        they understand the purpose of the study (including procedures, follow-up assessments, and&#xD;
        potential risks involved). Patients will be allowed to ask questions related to this study&#xD;
        and will be informed about alternative treatments.&#xD;
  &#xD;
        Surgical procedure.&#xD;
  &#xD;
        Presurgical planning will be performed with cone-beam computed tomography examination with or&#xD;
        without the use of image reconstruction software.&#xD;
  &#xD;
        After local anesthesia using articaine 4% with epinephrine 1:100,000, a minimally invasive&#xD;
        full-thickness flap will be raised in order to visualize the anatomy of the ridge. The&#xD;
        vertical thickness of the supracrestal soft tissue will be measured and recorded. The&#xD;
        preparation of the implant site will be performed with rotary burs and the bone quality will&#xD;
        be recorded. An implant (M2 Short, M2 Implants, Padova, Italy), 4 mm in diameter and 5, 6.5&#xD;
        or 7 mm in length, will be placed according to the manufacturer's recommendations (5 and 6.5&#xD;
        crestal placement; 7 subcrestal placement of 1 mm ). The length of the implant will be chosen&#xD;
        in order to obtain a bicortical anchorage on the floor of the maxillary sinus.&#xD;
  &#xD;
        Immediately after implant placement, an intraoral radiograph will be performed and an&#xD;
        operator will record the implant stability values in the mesio-distal, disto-mesial,&#xD;
        bucco-lingual and lingual-buccal directions. Dedicated disposable transducers and a measuring&#xD;
        device will be used. The calibration of the instrument will be checked before and after each&#xD;
        patient visit, using an implant fixed in a block of resin.&#xD;
  &#xD;
        The flap will be sutured around the implant (one-stage protocol) with a non-absorbable&#xD;
        monofilament, and an intraoral radiography with a centering device will be performed.&#xD;
  &#xD;
        Patients will be prescribed antibiotics (amoxicillin/clavulanic acid 1 g 2 tablets/day from&#xD;
        one day before surgery to five days after - clarithromycin 500 mg 1 tablet/day in allergic&#xD;
        patients), NSAID (ibuprofen 600 mg as needed) and mouthwashes of chlorhexidine 0.2% lasting&#xD;
        two minutes, three times a day.&#xD;
  &#xD;
        The sutures will be removed 14 days after the surgery.&#xD;
  &#xD;
        Postoperative recalls. After four months of healing, after periapical radiography and implant&#xD;
        stability control , the final impression will be taken for the construction of the prosthetic&#xD;
        product. The prosthetic rehabilitation will consist of single screw-retained ceramic crowns.&#xD;
        Periapical radiographs will be performed upon delivery of the prosthetic product, after six&#xD;
        months, one year, three and five years of prosthetic loading to evaluate the stability of the&#xD;
        marginal bone.&#xD;
  &#xD;
        Data analysis and retention. For each clinical center, a trained clinical operator and a&#xD;
        clinical assistant will take care of data collection (filling in the case report form,&#xD;
        performing periapical radiographs (on digital support) and measuring implant stability&#xD;
        quotient values. Case report forms, radiographs and implant stability quotient measurements&#xD;
        will be sent to the Coordination Centre, where trained operators will perform all&#xD;
        measurements. The data will be transferred into a single electronic dataset for subsequent&#xD;
        analysis. The examiners will not have been involved in the surgical and prosthetic phases and&#xD;
        will proceed with the observation of the radiographs in a blind manner.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 15, 2021</start_date>
    <completion_date type="Actual">July 15, 2023</completion_date>
    <primary_completion_date type="Actual">June 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>marginal bone loss</measure>
      <time_frame>six months</time_frame>
      <description>millimeter of peri-implant bone resorption</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>marginal bone loss</measure>
      <time_frame>one year</time_frame>
      <description>millimeter of peri-implant bone resorption</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">22</enrollment>
    <condition>Alveolar Bone Resorption</condition>
    <arm_group>
      <arm_group_label>trans-gingival short implants</arm_group_label>
      <description>trans-gingival implant insertion in the posterior atrophic maxilla</description>
    </arm_group>
    <arm_group>
      <arm_group_label>subcrestal short implants</arm_group_label>
      <description>subcrestal implant insertion in the posterior atrophic maxilla</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>implant insertion</intervention_name>
      <description>a minimally invasive full-thickness flap will be raised in order to visualize the anatomy of the ridge. The vertical thickness of the supracrestal soft tissue will be measured and recorded. The preparation of the implant site will be performed with rotary burs and the bone quality will be recorded. An implant will be placed according to the manufacturer's recommendations. The length of the implant will be chosen in order to obtain a bicortical anchorage on the floor of the maxillary sinus</description>
      <arm_group_label>subcrestal short implants</arm_group_label>
      <arm_group_label>trans-gingival short implants</arm_group_label>
      <other_name>dental implant positioning</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          people with an edentulous site in the posterior maxilla&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1) indications for an implant-prosthetic rehabilitation of a single edentulism in the&#xD;
               upper posterior arch, on the basis of an accurate diagnosis and treatment planning;&#xD;
  &#xD;
            -  2) the bone crest must be healed (at least six months after tooth loss);&#xD;
  &#xD;
            -  3) residual bone crest width ≥6 mm;&#xD;
  &#xD;
            -  4) presence of an available bone height between 4.5 and 8.5 mm on the floor of the&#xD;
               maxillary sinus in the area of the planned implant insertion;&#xD;
  &#xD;
            -  5) patient age &gt;18 years;&#xD;
  &#xD;
            -  6) the patient must not wear any type of removable prosthesis on the treated area;&#xD;
  &#xD;
            -  7) the patient must be able to follow the study protocol;&#xD;
  &#xD;
            -  8) written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) acute myocardial infarction in the last 2 months;&#xD;
  &#xD;
            -  2) uncontrolled bleeding disorders;&#xD;
  &#xD;
            -  3) uncontrolled diabetes (HBA1c &gt; 7.5);&#xD;
  &#xD;
            -  4) head/neck radiotherapy in the last 24 months;&#xD;
  &#xD;
            -  5) immunocompromised patients, HIV positive or undergoing chemotherapy in the last 5&#xD;
               years;&#xD;
  &#xD;
            -  6) current or past treatment with intravenous bisphosphonates;&#xD;
  &#xD;
            -  7) psychological or psychiatric problems;&#xD;
  &#xD;
            -  8) alcohol or drug abuse;&#xD;
  &#xD;
            -  9) The local exclusion criterion is the presence of uncontrolled periodontal disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>claudio stacchi, dr</last_name>
      <role>Study Chair</role>
      <affiliation>International Piezoelectric surgery Academy</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Piezosurgery Academy</name>
        <address>
          <city>Parma</city>
          <zip>43100</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Fan T, Li Y, Deng WW, Wu T, Zhang W. Short Implants (5 to 8 mm) Versus Longer Implants (&gt;8 mm) with Sinus Lifting in Atrophic Posterior Maxilla: A Meta-Analysis of RCTs. Clin Implant Dent Relat Res. 2017 Feb;19(1):207-215. doi: 10.1111/cid.12432. Epub 2016 Jun 13.</citation>
      <PMID>27295262</PMID>
    </reference>
    <reference>
      <citation>Han HC, Lim HC, Hong JY, Ahn SJ, Han JY, Shin SI, Chung JH, Herr Y, Shin SY. Primary implant stability in a bone model simulating clinical situations for the posterior maxilla: an in vitro study. J Periodontal Implant Sci. 2016 Aug;46(4):254-65. doi: 10.5051/jpis.2016.46.4.254. Epub 2016 Aug 30.</citation>
      <PMID>27588215</PMID>
    </reference>
    <reference>
      <citation>Mezzomo LA, Miller R, Triches D, Alonso F, Shinkai RS. Meta-analysis of single crowns supported by short (&lt;10 mm) implants in the posterior region. J Clin Periodontol. 2014 Feb;41(2):191-213. doi: 10.1111/jcpe.12180. Epub 2013 Nov 25.</citation>
      <PMID>24266703</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bone atrophy</keyword>
    <keyword>dental implant</keyword>
    <keyword>bone remodeling</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>only after data elaboration</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05975138
  org study id: M2TRANS-SUB
  nct id: NCT05975138
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  two groups of inserted implants: trans-gingival and under-bone level; difference in the
        marginal bone loss at six months from placement between the two groups of implant positioned
        in the posterior atrophic maxilla
  The inserted implants will be divided into two groups (group A: trans-gingival implants;
        group B: under bone level implants): a sample of 17 implants for each group was calculated to
        be necessary to detect a statistically significant difference in the marginal bone loss at
        six months from placement between the two groups (primary outcome) (alpha level set at 0.05
        and statistical power at 80%) (Primer 6.0, Mc Graw-Hill, USA). The expected differences in
        marginal bone loss between groups (0.1 ±0.1 mm) were extrapolated from literature studies
        conducted on the topic10. Each center will treat 15 patients who need to insert implants in
        the posterior maxillary area, for a total of 45 implants, in order to compensate for any
        drop-outs.
  
        Training and calibration session. Before the start of the study, a meeting will be held
        between all clinical centers to explain the surgical protocol, in order to ensure that
        clinical operators apply a standardized approach. A clinical operator for each center will
        receive written instructions regarding the evaluation of the experimental parameters in order
        to obtain repeatability in the collection of clinical parameters and in the compilation of
        the Case Report Form.
  
        Screening stage.
  
        All patients treated by the Clinical Centers are eligible to enter this study. Prior to
        enrollment, all patients will be required to sign an informed consent form to document that
        they understand the purpose of the study (including procedures, follow-up assessments, and
        potential risks involved). Patients will be allowed to ask questions related to this study
        and will be informed about alternative treatments.
  
        Surgical procedure.
  
        Presurgical planning will be performed with cone-beam computed tomography examination with or
        without the use of image reconstruction software.
  
        After local anesthesia using articaine 4% with epinephrine 1:100,000, a minimally invasive
        full-thickness flap will be raised in order to visualize the anatomy of the ridge. The
        vertical thickness of the supracrestal soft tissue will be measured and recorded. The
        preparation of the implant site will be performed with rotary burs and the bone quality will
        be recorded. An implant (M2 Short, M2 Implants, Padova, Italy), 4 mm in diameter and 5, 6.5
        or 7 mm in length, will be placed according to the manufacturer's recommendations (5 and 6.5
        crestal placement; 7 subcrestal placement of 1 mm ). The length of the implant will be chosen
        in order to obtain a bicortical anchorage on the floor of the maxillary sinus.
  
        Immediately after implant placement, an intraoral radiograph will be performed and an
        operator will record the implant stability values in the mesio-distal, disto-mesial,
        bucco-lingual and lingual-buccal directions. Dedicated disposable transducers and a measuring
        device will be used. The calibration of the instrument will be checked before and after each
        patient visit, using an implant fixed in a block of resin.
  
        The flap will be sutured around the implant (one-stage protocol) with a non-absorbable
        monofilament, and an intraoral radiography with a centering device will be performed.
  
        Patients will be prescribed antibiotics (amoxicillin/clavulanic acid 1 g 2 tablets/day from
        one day before surgery to five days after - clarithromycin 500 mg 1 tablet/day in allergic
        patients), NSAID (ibuprofen 600 mg as needed) and mouthwashes of chlorhexidine 0.2% lasting
        two minutes, three times a day.
  
        The sutures will be removed 14 days after the surgery.
  
        Postoperative recalls. After four months of healing, after periapical radiography and implant
        stability control , the final impression will be taken for the construction of the prosthetic
        product. The prosthetic rehabilitation will consist of single screw-retained ceramic crowns.
        Periapical radiographs will be performed upon delivery of the prosthetic product, after six
        months, one year, three and five years of prosthetic loading to evaluate the stability of the
        marginal bone.
  
        Data analysis and retention. For each clinical center, a trained clinical operator and a
        clinical assistant will take care of data collection (filling in the case report form,
        performing periapical radiographs (on digital support) and measuring implant stability
        quotient values. Case report forms, radiographs and implant stability quotient measurements
        will be sent to the Coordination Centre, where trained operators will perform all
        measurements. The data will be transferred into a single electronic dataset for subsequent
        analysis. The examiners will not have been involved in the surgical and prosthetic phases and
        will proceed with the observation of the radiographs in a blind manner.
  observational model: Case-Control
  time perspective: Prospective
  measure: marginal bone loss
  time frame: six months
  description: millimeter of peri-implant bone resorption
  measure: marginal bone loss
  time frame: one year
  description: millimeter of peri-implant bone resorption
  arm group label: trans-gingival short implants
  description: trans-gingival implant insertion in the posterior atrophic maxilla
  arm group label: subcrestal short implants
  description: subcrestal implant insertion in the posterior atrophic maxilla
  intervention type: Procedure
  intervention name: implant insertion
  description: a minimally invasive full-thickness flap will be raised in order to visualize the anatomy of the ridge. The vertical thickness of the supracrestal soft tissue will be measured and recorded. The preparation of the implant site will be performed with rotary burs and the bone quality will be recorded. An implant will be placed according to the manufacturer's recommendations. The length of the implant will be chosen in order to obtain a bicortical anchorage on the floor of the maxillary sinus
  arm group label: subcrestal short implants
  arm group label: trans-gingival short implants
  other name: dental implant positioning
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  last name: claudio stacchi, dr
  role: Study Chair
  affiliation: International Piezoelectric surgery Academy
  facility: 
  country: Italy
  citation: Fan T, Li Y, Deng WW, Wu T, Zhang W. Short Implants (5 to 8 mm) Versus Longer Implants (>8 mm) with Sinus Lifting in Atrophic Posterior Maxilla: A Meta-Analysis of RCTs. Clin Implant Dent Relat Res. 2017 Feb;19(1):207-215. doi: 10.1111/cid.12432. Epub 2016 Jun 13.
  PMID: 27295262
  citation: Han HC, Lim HC, Hong JY, Ahn SJ, Han JY, Shin SI, Chung JH, Herr Y, Shin SY. Primary implant stability in a bone model simulating clinical situations for the posterior maxilla: an in vitro study. J Periodontal Implant Sci. 2016 Aug;46(4):254-65. doi: 10.5051/jpis.2016.46.4.254. Epub 2016 Aug 30.
  PMID: 27588215
  citation: Mezzomo LA, Miller R, Triches D, Alonso F, Shinkai RS. Meta-analysis of single crowns supported by short (<10 mm) implants in the posterior region. J Clin Periodontol. 2014 Feb;41(2):191-213. doi: 10.1111/jcpe.12180. Epub 2013 Nov 25.
  PMID: 24266703
  responsible party type: Sponsor
  mesh term: Bone Resorption
  sharing ipd: No
  ipd description: only after data elaboration