<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/NCT03229005</url>
  </required_header>
  <id_info>
    <org_study_id>i-RES</org_study_id>
    <nct_id>NCT03229005</nct_id>
  </id_info>
  <brief_title>Soft Tissue Width and Abutment Height Influence Peri-implant Bone Resorption</brief_title>
  <acronym>i-RES</acronym>
  <official_title>Influence of Soft Tissue Width and Abutment Height on Peri-implant Bone Resorption: a Clinical and Radiographic Multicenter 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>
      The purpose of this clinical and radiographic study will be to determine what influence on&#xD;
      marginal bone loss has the thickness of soft tissues and the height of the prosthetic&#xD;
      abutment and eventually determine which of the two factors is the most important.This&#xD;
      research was designed as a multicentre cohort study. Two clinical centers will treat patients&#xD;
      through the placement of a single dental implant. The implants will be prosthetically loaded&#xD;
      about 4 months after placement and periapical radiographs will be acquired at each&#xD;
      time-point.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical and radiographic study will be to determine what influence on&#xD;
      marginal bone loss has the thickness of soft tissues and the height of the prosthetic&#xD;
      abutment and eventually determine which of the two factors is the most important.This&#xD;
      research was designed as a multicentre cohort observational study. Two clinical centers will&#xD;
      treat patients through the placement of a single dental implant. The implants will be&#xD;
      prosthetically loaded about 4 months after placement and periapical radiographs will be&#xD;
      acquired at each time-point.&#xD;
&#xD;
      All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before&#xD;
      surgery. With the help of a dissector, a full thickness vestibular flap will be carefully&#xD;
      arranged and the vertical thickness of soft tissues will be measured with a probe marked&#xD;
      every 1.0 mm. If the vertical thickness of the soft tissue is 2 mm or less, the tissue will&#xD;
      be considered thin. If the thickness of the mucosa is greater than 2 mm, it will be&#xD;
      considered thick. After the measurement, the lingual flap will be elevated at full thickness,&#xD;
      and the site for site placement will be prepared. The implant bed will be at least 1.5 mm&#xD;
      from the adjacent tooth or teeth, and must be surrounded by at least 1 mm bone in both buccal&#xD;
      and lingual directions. A 3,75 mm diameter and internal hexagonal connection implant will be&#xD;
      placed at the level of the bone crest according to the manufacturer's recommendations.&#xD;
      Operators will be free to choose the most suitable system length (8, 10, 11.5 mm). All&#xD;
      implants will be submerged according to a traditional two-stage protocol. After insertion,&#xD;
      the flaps will be sutured without tension with interrupted sutures. Patients of both groups&#xD;
      will be instructed to disinfect the site by rinsing twice daily for one week for 1 minute&#xD;
      with 0.12% chlorhexidine. After 4 months of healing, the treated area will be reopened for&#xD;
      connecting the healing abutments with a crestal incision that will retain the keratinized&#xD;
      tissue; The same soft tissue measurements will be repeated as confirmation of what was done&#xD;
      during the first surgical implant insertion phase. The implants will be considered&#xD;
      osteointegrated successfully if they are clinically intact unless they show obvious&#xD;
      radiotransparency and patients will not report any pain. After this step, it will be possible&#xD;
      to divide the patients into 2 groups according to the thickness of the soft tissue: a group&#xD;
      with thick tissue (more than 2.0 mm); Slim tissue group (less than 2.0 mm). The prosthetic&#xD;
      framework will be bonded directly to prefabricated titanium abutment (1 or 3 mm). This will&#xD;
      result in the formation of 4 different subgroups: a group with thick tissue and high&#xD;
      prosthetic abutment; A group with thick tissue and low prosthetic stump; a group with thin&#xD;
      tissue and high prosthetic abutment; a group with thin tissue and low prosthetic abutment.&#xD;
&#xD;
      All the implants will be rehabilitated by the dentist with screwed restorations. After&#xD;
      prosthetic treatment, patients will receive oral hygiene instructions and will be monitored&#xD;
      through calls to ensure periodontal health throughout the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">June 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>peri-implant bone resorption</measure>
    <time_frame>after 12 months</time_frame>
    <description>intraoral radiographs will be acquired and bone crest level will be compared with baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>implant survival</measure>
    <time_frame>after 12 months</time_frame>
    <description>clinical and radiographical examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>peri-implant bone resorption</measure>
    <time_frame>immediately after surgery (baseline)</time_frame>
    <description>intraoral radiographs will be acquired</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peri-implant bone resorption</measure>
    <time_frame>four months after surgery (at prosthesis delivery)</time_frame>
    <description>intraoral radiographs will be acquired</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peri-implant bone resorption</measure>
    <time_frame>six months after prosthetic loading</time_frame>
    <description>intraoral radiographs will be acquired</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peri-implant bone resorption</measure>
    <time_frame>24 months after prosthetic loading</time_frame>
    <description>intraoral radiographs will be acquired</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications and/or adverse events</measure>
    <time_frame>any time of the study</time_frame>
    <description>clinical and radiographical examination</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Alveolar Bone Loss</condition>
  <arm_group>
    <arm_group_label>A1 thick-high</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A2 thick-low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B1 thin-high</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B2 thin-low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>implant insertion</intervention_name>
    <description>during surgery soft tissues will be measured</description>
    <arm_group_label>A1 thick-high</arm_group_label>
    <arm_group_label>A2 thick-low</arm_group_label>
    <arm_group_label>B1 thin-high</arm_group_label>
    <arm_group_label>B2 thin-low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>operculectomy</intervention_name>
    <description>during second surgery soft tissues will be measured again</description>
    <arm_group_label>A1 thick-high</arm_group_label>
    <arm_group_label>A2 thick-low</arm_group_label>
    <arm_group_label>B1 thin-high</arm_group_label>
    <arm_group_label>B2 thin-low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>prosthetic rehabilitation</intervention_name>
    <description>after three months implants will be loaded with screw retained crown</description>
    <arm_group_label>A1 thick-high</arm_group_label>
    <arm_group_label>A2 thick-low</arm_group_label>
    <arm_group_label>B1 thin-high</arm_group_label>
    <arm_group_label>B2 thin-low</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        General inclusion criteria were:&#xD;
&#xD;
          -  age&gt;18 years;&#xD;
&#xD;
          -  good general health;&#xD;
&#xD;
          -  non smokers;&#xD;
&#xD;
          -  absence of systemic diseases affecting bone metabolism and wound healing; - no regular&#xD;
             medication consumption for at least 3 months prior to treatment; - patient willing and&#xD;
             fully capable to comply with the study protocol;&#xD;
&#xD;
          -  written informed consent given.&#xD;
&#xD;
        Local inclusion criteria were:&#xD;
&#xD;
          -  presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm; - bone&#xD;
             crest with at least 6 mm of width and 9 mm of height above the mandibular canal,&#xD;
             without concomitant or previous bone augmentation procedures;&#xD;
&#xD;
          -  presence of the opposing dentition.&#xD;
&#xD;
        Exclusion criteria were:&#xD;
&#xD;
          -  history of head or neck radiation therapy;&#xD;
&#xD;
          -  uncontrolled diabetes (HBA1c &gt;7.5%);&#xD;
&#xD;
          -  active infections;&#xD;
&#xD;
          -  immunocompromised patients (HIV infection or chemotherapy within the past 5 years);&#xD;
&#xD;
          -  present or past treatment with intravenous bisphosphonates;&#xD;
&#xD;
          -  patient pregnancy or lactating at any time during the study;&#xD;
&#xD;
          -  poor oral hygiene and motivation;&#xD;
&#xD;
          -  untreated periodontal disease;&#xD;
&#xD;
          -  psychological or psychiatric problems;&#xD;
&#xD;
          -  alcohol or drugs abuse;&#xD;
&#xD;
          -  participating in other studies, if the present protocol could not be properly&#xD;
             followed;&#xD;
&#xD;
          -  lack of implant primary stability.&#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>Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.</citation>
    <PMID>25678247</PMID>
  </reference>
  <reference>
    <citation>Linkevicius T, Apse P, Grybauskas S, Puisys A. Influence of thin mucosal tissues on crestal bone stability around implants with platform switching: a 1-year pilot study. J Oral Maxillofac Surg. 2010 Sep;68(9):2272-7. doi: 10.1016/j.joms.2009.08.018.</citation>
    <PMID>20605308</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 22, 2017</study_first_submitted>
  <study_first_submitted_qc>July 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</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>soft tissue; implant; abutment;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
    <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/NCT03229005
org study id: i-RES
nct id: NCT03229005
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this clinical and radiographic study will be to determine what influence on
      marginal bone loss has the thickness of soft tissues and the height of the prosthetic
      abutment and eventually determine which of the two factors is the most important.This
      research was designed as a multicentre cohort study. Two clinical centers will treat patients
      through the placement of a single dental implant. The implants will be prosthetically loaded
      about 4 months after placement and periapical radiographs will be acquired at each
      time-point.
The purpose of this clinical and radiographic study will be to determine what influence on
      marginal bone loss has the thickness of soft tissues and the height of the prosthetic
      abutment and eventually determine which of the two factors is the most important.This
      research was designed as a multicentre cohort observational study. Two clinical centers will
      treat patients through the placement of a single dental implant. The implants will be
      prosthetically loaded about 4 months after placement and periapical radiographs will be
      acquired at each time-point.

      All patients will receive antibiotic prophylaxis with 2 g of amoxicillin one hour before
      surgery. With the help of a dissector, a full thickness vestibular flap will be carefully
      arranged and the vertical thickness of soft tissues will be measured with a probe marked
      every 1.0 mm. If the vertical thickness of the soft tissue is 2 mm or less, the tissue will
      be considered thin. If the thickness of the mucosa is greater than 2 mm, it will be
      considered thick. After the measurement, the lingual flap will be elevated at full thickness,
      and the site for site placement will be prepared. The implant bed will be at least 1.5 mm
      from the adjacent tooth or teeth, and must be surrounded by at least 1 mm bone in both buccal
      and lingual directions. A 3,75 mm diameter and internal hexagonal connection implant will be
      placed at the level of the bone crest according to the manufacturer's recommendations.
      Operators will be free to choose the most suitable system length (8, 10, 11.5 mm). All
      implants will be submerged according to a traditional two-stage protocol. After insertion,
      the flaps will be sutured without tension with interrupted sutures. Patients of both groups
      will be instructed to disinfect the site by rinsing twice daily for one week for 1 minute
      with 0.12% chlorhexidine. After 4 months of healing, the treated area will be reopened for
      connecting the healing abutments with a crestal incision that will retain the keratinized
      tissue; The same soft tissue measurements will be repeated as confirmation of what was done
      during the first surgical implant insertion phase. The implants will be considered
      osteointegrated successfully if they are clinically intact unless they show obvious
      radiotransparency and patients will not report any pain. After this step, it will be possible
      to divide the patients into 2 groups according to the thickness of the soft tissue: a group
      with thick tissue (more than 2.0 mm); Slim tissue group (less than 2.0 mm). The prosthetic
      framework will be bonded directly to prefabricated titanium abutment (1 or 3 mm). This will
      result in the formation of 4 different subgroups: a group with thick tissue and high
      prosthetic abutment; A group with thick tissue and low prosthetic stump; a group with thin
      tissue and high prosthetic abutment; a group with thin tissue and low prosthetic abutment.

      All the implants will be rehabilitated by the dentist with screwed restorations. After
      prosthetic treatment, patients will receive oral hygiene instructions and will be monitored
      through calls to ensure periodontal health throughout the study period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: peri-implant bone resorption
time frame: after 12 months
description: intraoral radiographs will be acquired and bone crest level will be compared with baseline
measure: implant survival
time frame: after 12 months
description: clinical and radiographical examination
measure: peri-implant bone resorption
time frame: immediately after surgery (baseline)
description: intraoral radiographs will be acquired
measure: peri-implant bone resorption
time frame: four months after surgery (at prosthesis delivery)
description: intraoral radiographs will be acquired
measure: peri-implant bone resorption
time frame: six months after prosthetic loading
description: intraoral radiographs will be acquired
measure: peri-implant bone resorption
time frame: 24 months after prosthetic loading
description: intraoral radiographs will be acquired
measure: complications and/or adverse events
time frame: any time of the study
description: clinical and radiographical examination
arm group label: A1 thick-high
arm group type: Active Comparator
description: group with thick tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
arm group label: A2 thick-low
arm group type: Experimental
description: group with thick tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
arm group label: B1 thin-high
arm group type: Active Comparator
description: group with thin tissue and high prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
arm group label: B2 thin-low
arm group type: Experimental
description: group with thin tissue and low prosthetic abutment tissue measurement implant insertion operculectomy prosthetic rehabilitation
intervention type: Procedure
intervention name: implant insertion
description: during surgery soft tissues will be measured
arm group label: A1 thick-high
arm group label: A2 thick-low
arm group label: B1 thin-high
arm group label: B2 thin-low
intervention type: Procedure
intervention name: operculectomy
description: during second surgery soft tissues will be measured again
arm group label: A1 thick-high
arm group label: A2 thick-low
arm group label: B1 thin-high
arm group label: B2 thin-low
intervention type: Procedure
intervention name: prosthetic rehabilitation
description: after three months implants will be loaded with screw retained crown
arm group label: A1 thick-high
arm group label: A2 thick-low
arm group label: B1 thin-high
arm group label: B2 thin-low
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: Galindo-Moreno P, Leon-Cano A, Monje A, Ortega-Oller I, O'Valle F, Catena A. Abutment height influences the effect of platform switching on peri-implant marginal bone loss. Clin Oral Implants Res. 2016 Feb;27(2):167-73. doi: 10.1111/clr.12554. Epub 2015 Feb 11.
PMID: 25678247
citation: Linkevicius T, Apse P, Grybauskas S, Puisys A. Influence of thin mucosal tissues on crestal bone stability around implants with platform switching: a 1-year pilot study. J Oral Maxillofac Surg. 2010 Sep;68(9):2272-7. doi: 10.1016/j.joms.2009.08.018.
PMID: 20605308
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: Bone Resorption
mesh term: Alveolar Bone Loss
sharing ipd: No