<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/NCT03806608</url>
  </required_header>
  <id_info>
    <org_study_id>Baoxin Huang Depth</org_study_id>
    <nct_id>NCT03806608</nct_id>
  </id_info>
  <brief_title>Evaluation of MBL Around Implants Placed in Crestal or Subcrestal Positions: a RCT</brief_title>
  <official_title>Clinical and Radiographic Evaluation of Marginal Bone Changes Around Platform-switching Implants Placed in Crestal or Subcrestal Positions: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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>
      The objective of this randomized controlled trial is to evaluate changes in marginal bone&#xD;
      levels and soft tissue dimensions around implants placed with the IAI at different positions&#xD;
      in relation to the alveolar crest&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this randomized controlled trial is to evaluate changes in marginal bone&#xD;
      levels and soft tissue dimensions around implants placed with the IAI at different positions&#xD;
      in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in&#xD;
      the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two&#xD;
      implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of&#xD;
      each patient with a predefined randomization tables (one crestal implant and one subcrestal&#xD;
      implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at&#xD;
      1year, 3 years, 5 years after final restoration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 17, 2019</start_date>
  <completion_date type="Anticipated">May 2026</completion_date>
  <primary_completion_date type="Anticipated">May 2026</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal bone loss(MBL)</measure>
    <time_frame>Change from baseline up to 5 years after implantation</time_frame>
    <description>Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative survival rate (CSR)</measure>
    <time_frame>Up to 5 years after final restoration</time_frame>
    <description>Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket probing depth (PPD)</measure>
    <time_frame>Up to 5 years after final restoration</time_frame>
    <description>Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index (PI)</measure>
    <time_frame>Up to 5 years after final restoration</time_frame>
    <description>Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing (BOP)</measure>
    <time_frame>Up to 5 years after final restoration</time_frame>
    <description>Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Jaw, Edentulous</condition>
  <condition>Partial Edentulism</condition>
  <arm_group>
    <arm_group_label>Crestal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcrestal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Crestal</intervention_name>
    <description>Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).</description>
    <arm_group_label>Crestal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subcrestal</intervention_name>
    <description>Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).</description>
    <arm_group_label>Subcrestal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Absence of 2-4 teeth in the posterior region of the maxilla or mandibular;&#xD;
&#xD;
          2. Bone volume sufficient for implants with 4.1-mm size and 8- to 12-mm height and with&#xD;
             no need for hard or soft tissue augmentation for implant treatment;&#xD;
&#xD;
          3. Periodontally healthy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Systemic diseases that may affect bone and soft tissue healing, such as diabetes,&#xD;
             osteoporosis, Paget's disease, and patients with cancer;&#xD;
&#xD;
          2. Uncontrolled periodontal disease or poor oral health with neither good nor adequate&#xD;
             plaque control;&#xD;
&#xD;
          3. Parafunctional habits, such as the grinding or clenching of teeth;&#xD;
&#xD;
          4. Smoking habit (more than 10 cigarettes per day);&#xD;
&#xD;
          5. Pregnancy and breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baoxin Huang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen Unniversity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Huang B, Meng H, Zhu W, Witek L, Tovar N, Coelho PG. Influence of placement depth on bone remodeling around tapered internal connection implants: a histologic study in dogs. Clin Oral Implants Res. 2015 Aug;26(8):942-949. doi: 10.1111/clr.12384. Epub 2014 Apr 10.</citation>
    <PMID>24720447</PMID>
  </reference>
  <reference>
    <citation>Huang B, Meng H, Piao M, Xu L, Zhang L, Zhu W. Influence of placement depth on bone remodeling around tapered internal connection implant: a clinical and radiographic study in dogs. J Periodontol. 2012 Sep;83(9):1164-71. doi: 10.1902/jop.2012.110617. Epub 2012 Jan 5.</citation>
    <PMID>22220773</PMID>
  </reference>
  <reference>
    <citation>Koutouzis T, Neiva R, Nonhoff J, Lundgren T. Placement of implants with platform-switched Morse taper connections with the implant-abutment interface at different levels in relation to the alveolar crest: a short-term (1-year) randomized prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1553-63. doi: 10.11607/jomi.3184.</citation>
    <PMID>24278924</PMID>
  </reference>
  <reference>
    <citation>Valles C, Rodriguez-Ciurana X, Clementini M, Baglivo M, Paniagua B, Nart J. Influence of subcrestal implant placement compared with equicrestal position on the peri-implant hard and soft tissues around platform-switched implants: a systematic review and meta-analysis. Clin Oral Investig. 2018 Mar;22(2):555-570. doi: 10.1007/s00784-017-2301-1. Epub 2018 Jan 8.</citation>
    <PMID>29313133</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Baoxin Huang</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>Marginal Bone Loss</keyword>
  <keyword>Implant depth</keyword>
  <keyword>Crestal or Subcrestal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaw, Edentulous</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03806608
org study id: Baoxin Huang Depth
nct id: NCT03806608
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized controlled trial is to evaluate changes in marginal bone
      levels and soft tissue dimensions around implants placed with the IAI at different positions
      in relation to the alveolar crest
The objective of this randomized controlled trial is to evaluate changes in marginal bone
      levels and soft tissue dimensions around implants placed with the IAI at different positions
      in relation to the alveolar crest. Subjects will be included with the absence of 2-4 teeth in
      the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two
      implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of
      each patient with a predefined randomization tables (one crestal implant and one subcrestal
      implant). Patients will be recalled for oral hygiene maintenance and prosthetic controls at
      1year, 3 years, 5 years after final restoration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Marginal bone loss(MBL)
time frame: Change from baseline up to 5 years after implantation
description: Baseline will be recorded at the time of implantation. Margin bone loss(MBL) will be recorded at 0 day, 4 months, 1 year and 3 years after implant placement.
measure: Cumulative survival rate (CSR)
time frame: Up to 5 years after final restoration
description: Cumulative survival rate will be assessed at final restoration, 1 year, 3 years, 5 years after final restoration
measure: Pocket probing depth (PPD)
time frame: Up to 5 years after final restoration
description: Pocket probing depth will be assessed at 1 year, 3 years, 5 years after final restoration
measure: Plaque index (PI)
time frame: Up to 5 years after final restoration
description: Plaque index will be assessed at 1 year, 3 years, 5 years after final restoration
measure: Bleeding on probing (BOP)
time frame: Up to 5 years after final restoration
description: Bleeding on probing will be assessed at 1 year, 3 years, 5 years after final restoration
arm group label: Crestal
arm group type: Experimental
description: Implants were placed with the implant-abutment interface(IAI) at the level of the the alveolar ridge
arm group label: Subcrestal
arm group type: Experimental
description: Implants were placed with the implant-abutment interface(IAI) 1 mm below the level of the alveolar ridge
intervention type: Procedure
intervention name: Crestal
description: Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
arm group label: Crestal
intervention type: Procedure
intervention name: Subcrestal
description: Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
arm group label: Subcrestal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Baoxin Huang, PhD
role: Principal Investigator
affiliation: Sun Yat-sen Unniversity
facility: 
country: China
citation: Huang B, Meng H, Zhu W, Witek L, Tovar N, Coelho PG. Influence of placement depth on bone remodeling around tapered internal connection implants: a histologic study in dogs. Clin Oral Implants Res. 2015 Aug;26(8):942-949. doi: 10.1111/clr.12384. Epub 2014 Apr 10.
PMID: 24720447
citation: Huang B, Meng H, Piao M, Xu L, Zhang L, Zhu W. Influence of placement depth on bone remodeling around tapered internal connection implant: a clinical and radiographic study in dogs. J Periodontol. 2012 Sep;83(9):1164-71. doi: 10.1902/jop.2012.110617. Epub 2012 Jan 5.
PMID: 22220773
citation: Koutouzis T, Neiva R, Nonhoff J, Lundgren T. Placement of implants with platform-switched Morse taper connections with the implant-abutment interface at different levels in relation to the alveolar crest: a short-term (1-year) randomized prospective controlled clinical trial. Int J Oral Maxillofac Implants. 2013 Nov-Dec;28(6):1553-63. doi: 10.11607/jomi.3184.
PMID: 24278924
citation: Valles C, Rodriguez-Ciurana X, Clementini M, Baglivo M, Paniagua B, Nart J. Influence of subcrestal implant placement compared with equicrestal position on the peri-implant hard and soft tissues around platform-switched implants: a systematic review and meta-analysis. Clin Oral Investig. 2018 Mar;22(2):555-570. doi: 10.1007/s00784-017-2301-1. Epub 2018 Jan 8.
PMID: 29313133
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Baoxin Huang
investigator title: Principle Investigator
mesh term: Jaw, Edentulous
sharing ipd: Undecided