<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/NCT03787355</url>
  </required_header>
  <id_info>
    <org_study_id>PERIO7:4:85</org_study_id>
    <nct_id>NCT03787355</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments</brief_title>
  <official_title>Clinical Evaluation of Vertical Inter-implant Papilla Height in Platform Matched Implants in Comparison to Morse Connection Abutments: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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 complete fill of the inter-implant mucosa is much more challenging between two implants,&#xD;
      than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However,&#xD;
      previous clinical studies have pointed to a relationship between the inter-implant mucosa&#xD;
      fill and the horizontal distance between two adjacent implants. In particular, a greater&#xD;
      inter-implant bone loss and the absence of the inter-implant mucosa were noted when&#xD;
      neighboring implants were not separated by more than 3 mm (Tarnow, Magner and Fletcher,&#xD;
      1992).&#xD;
&#xD;
      The implant-abutment connection may have an impact on the amount such inter-implant bone&#xD;
      loss, with morse-taper (MT) abutments emerging from the central region of the implant allow&#xD;
      additional thickness in the horizontal soft-tissue component. This might help reducing&#xD;
      marginal bone remodeling during biological width formation. Moreover, the literature&#xD;
      indicates that the peri-implant bone strain vary significantly with the type of&#xD;
      implant-abutment connection. The conical interface of MT connections helps dissipating the&#xD;
      forces to the fixture.&#xD;
&#xD;
      The aim of the study is to clinically investigate the fate of soft tissue and papilla&#xD;
      following crown placement on neighboring morse cone implants versus non-platform switched&#xD;
      implants denoting the fate of soft tissue and papilla.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of&#xD;
           Oral and Dental Medicine - Cairo University, Egypt.&#xD;
&#xD;
        -  Patients are to be selected from the outpatient clinic of the department of Oral&#xD;
           Medicine and Periodontology-Cairo University.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Clinical examination:&#xD;
&#xD;
        1. Evaluation of the patient's general condition of the oral cavity, to make sure it&#xD;
           complies with the criteria required to be enrolled in the study in terms of oral&#xD;
           hygiene, pathological conditions, occlusion and inter-arch space.&#xD;
&#xD;
        2. Evaluation of the periapical condition and crestal bone level using a periapical&#xD;
           radiograph.&#xD;
&#xD;
        3. Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal&#xD;
           probe.&#xD;
&#xD;
        4. Width of keratinized gingiva (measured by a periodontal probe from the gingival margin&#xD;
           to the mucogingival junction). It is measured at three areas (mesial, midbuccal and&#xD;
           distal).&#xD;
&#xD;
      SURGICAL PROTOCOL (T0):&#xD;
&#xD;
        -  Patients meeting the inclusion criteria, CBCT analysis and extensive diagnosis is done&#xD;
           to plan for treatment.&#xD;
&#xD;
        -  After randomization patients are assigned to one of the two groups&#xD;
&#xD;
        -  After profound anesthesia administration, a full thickness crestal flap is reflected,&#xD;
           sequential osteotomy of the implant sites to the desired depth is performed with great&#xD;
           care of interimplant distance maintenance to a 3-4mm.&#xD;
&#xD;
        -  Implant insertion and confirmatory x-rays are performed.&#xD;
&#xD;
        -  Gingival formers will be placed.&#xD;
&#xD;
        -  Flap closure is performed with interrupted 4-0 polyproplene sutures.&#xD;
&#xD;
      Postoperative Care:&#xD;
&#xD;
      Postoperative medication -Administration of:&#xD;
&#xD;
        1. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days)&#xD;
           (Francesco Pieri et al, 2012).&#xD;
&#xD;
        2. Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse) will be prescribed starting from&#xD;
           the second day for 60 seconds two times a day for 14 days (Jun Yu et al, 2015).&#xD;
&#xD;
           -Patient self-care instructions:&#xD;
&#xD;
        3. Application of an ice bag to the treated area for the first 24 hours (Francesco Pieri et&#xD;
           al, 2012).&#xD;
&#xD;
        4. The patients were instructed to gently brush the operated area starting from the second&#xD;
           day with a soft brush using roll technique.&#xD;
&#xD;
      Scheduled time of re-entry for patients:&#xD;
&#xD;
      3 months for prosthesis fabrication.&#xD;
&#xD;
      Clinical Examinations:&#xD;
&#xD;
      At the 3-month (T1), 6-month (T2) and 12-month (T3), the following clinical parameters will&#xD;
      be recorded at the implant sites: Interimplant vertical papilla height, pink esthestic score&#xD;
      (PES), probing depth (PD), peri-implant mucosal height (PMH), bleeding on probing at six&#xD;
      sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and&#xD;
      mesiolingual), and width of buccal keratinized mucosa (KM) at the midbuccal surface of each&#xD;
      implant.&#xD;
&#xD;
      KM will be recorded as the linear distance from the mucosal margin to the mucogingival line.&#xD;
&#xD;
      Radiographic Examination Radiographic examination will be performed immediately after the&#xD;
      surgical procedure (T0), and at T1 and T3. Standard periapical radiographs will be taken&#xD;
      using a digital imaging software system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 17, 2019</start_date>
  <completion_date type="Anticipated">January 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 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>Intervention versus Control.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vertical papilla height</measure>
    <time_frame>6,12 months from T0 (Implant insertion)</time_frame>
    <description>Change will be measured using periodontal probe in millimeters,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pink esthetic score (PES)</measure>
    <time_frame>12 months from T0 (Implant insertion)</time_frame>
    <description>Numerical Rating Score (Fürhauser et al, 2005)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crestal bone resorption</measure>
    <time_frame>T0 at the time of implant insertion, T1 at 3 months after implant insertion and at T3 at 12 months after implant insertion.</time_frame>
    <description>Using digital X-ray, bone resorption will be measured using a software in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth (PD)</measure>
    <time_frame>3, 6,12 months from T0 (Implant insertion)</time_frame>
    <description>six sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing (BOP)</measure>
    <time_frame>at T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).</time_frame>
    <description>Binary, Using periodontal probe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Width of buccal keratinized mucosa (KM)</measure>
    <time_frame>3, 6,12 months from T0 (Implant insertion)</time_frame>
    <description>Measured at the midbuccal surface of each implant using periodontal probe in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction (cleaning, food impaction)</measure>
    <time_frame>At T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).</time_frame>
    <description>Measured using Numerical Rating Scale (NRS) (Kiyak et al, 1984)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Interimplant Mucosa</condition>
  <arm_group>
    <arm_group_label>Cone Morse Connection Implants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 neighboring Morse connection Implants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>platform matched implants</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2 neighboring platform matched implants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Morse connection Implants</intervention_name>
    <description>2 neighboring morse connection Implants of Zinedent - Strauman</description>
    <arm_group_label>Cone Morse Connection Implants</arm_group_label>
    <arm_group_label>platform matched implants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy patients.&#xD;
&#xD;
          -  Good oral hygiene.&#xD;
&#xD;
          -  Missing minimum of two neighboring maxillary teeth with sufficient bucco-palatal bone&#xD;
             of ≥ 6mm.&#xD;
&#xD;
          -  Interimplant distance planned to be 3-4 mm.&#xD;
&#xD;
          -  Patient acceptance of more than one year of follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vertically deficient ridges. (≤10 mm)&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Thin biotype&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nada Zazou, Masters</last_name>
    <phone>02-01224016945</phone>
    <email>drzazou@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>12613</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nada Zazou, Masters</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>September 13, 2021</last_update_submitted>
  <last_update_submitted_qc>September 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nada Zazou</investigator_full_name>
    <investigator_title>Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA).</investigator_title>
  </responsible_party>
  <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/NCT03787355
org study id: PERIO7:4:85
nct id: NCT03787355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The complete fill of the inter-implant mucosa is much more challenging between two implants,
      than single implants, and is considered to be unpredictable (Tymstra et al., 2011). However,
      previous clinical studies have pointed to a relationship between the inter-implant mucosa
      fill and the horizontal distance between two adjacent implants. In particular, a greater
      inter-implant bone loss and the absence of the inter-implant mucosa were noted when
      neighboring implants were not separated by more than 3 mm (Tarnow, Magner and Fletcher,
      1992).

      The implant-abutment connection may have an impact on the amount such inter-implant bone
      loss, with morse-taper (MT) abutments emerging from the central region of the implant allow
      additional thickness in the horizontal soft-tissue component. This might help reducing
      marginal bone remodeling during biological width formation. Moreover, the literature
      indicates that the peri-implant bone strain vary significantly with the type of
      implant-abutment connection. The conical interface of MT connections helps dissipating the
      forces to the fixture.

      The aim of the study is to clinically investigate the fate of soft tissue and papilla
      following crown placement on neighboring morse cone implants versus non-platform switched
      implants denoting the fate of soft tissue and papilla.
-  Study is to be conducted in the Oral Medicine and Periodontology department, Faculty of
           Oral and Dental Medicine - Cairo University, Egypt.

        -  Patients are to be selected from the outpatient clinic of the department of Oral
           Medicine and Periodontology-Cairo University.

      Intervention:

      Clinical examination:

        1. Evaluation of the patient's general condition of the oral cavity, to make sure it
           complies with the criteria required to be enrolled in the study in terms of oral
           hygiene, pathological conditions, occlusion and inter-arch space.

        2. Evaluation of the periapical condition and crestal bone level using a periapical
           radiograph.

        3. Evaluation of the soft tissue biotype by trans-gingival piercing using a periodontal
           probe.

        4. Width of keratinized gingiva (measured by a periodontal probe from the gingival margin
           to the mucogingival junction). It is measured at three areas (mesial, midbuccal and
           distal).

      SURGICAL PROTOCOL (T0):

        -  Patients meeting the inclusion criteria, CBCT analysis and extensive diagnosis is done
           to plan for treatment.

        -  After randomization patients are assigned to one of the two groups

        -  After profound anesthesia administration, a full thickness crestal flap is reflected,
           sequential osteotomy of the implant sites to the desired depth is performed with great
           care of interimplant distance maintenance to a 3-4mm.

        -  Implant insertion and confirmatory x-rays are performed.

        -  Gingival formers will be placed.

        -  Flap closure is performed with interrupted 4-0 polyproplene sutures.

      Postoperative Care:

      Postoperative medication -Administration of:

        1. Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days)
           (Francesco Pieri et al, 2012).

        2. Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse) will be prescribed starting from
           the second day for 60 seconds two times a day for 14 days (Jun Yu et al, 2015).

           -Patient self-care instructions:

        3. Application of an ice bag to the treated area for the first 24 hours (Francesco Pieri et
           al, 2012).

        4. The patients were instructed to gently brush the operated area starting from the second
           day with a soft brush using roll technique.

      Scheduled time of re-entry for patients:

      3 months for prosthesis fabrication.

      Clinical Examinations:

      At the 3-month (T1), 6-month (T2) and 12-month (T3), the following clinical parameters will
      be recorded at the implant sites: Interimplant vertical papilla height, pink esthestic score
      (PES), probing depth (PD), peri-implant mucosal height (PMH), bleeding on probing at six
      sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and
      mesiolingual), and width of buccal keratinized mucosa (KM) at the midbuccal surface of each
      implant.

      KM will be recorded as the linear distance from the mucosal margin to the mucogingival line.

      Radiographic Examination Radiographic examination will be performed immediately after the
      surgical procedure (T0), and at T1 and T3. Standard periapical radiographs will be taken
      using a digital imaging software system.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention versus Control.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Vertical papilla height
time frame: 6,12 months from T0 (Implant insertion)
description: Change will be measured using periodontal probe in millimeters,
measure: Pink esthetic score (PES)
time frame: 12 months from T0 (Implant insertion)
description: Numerical Rating Score (Fürhauser et al, 2005)
measure: Crestal bone resorption
time frame: T0 at the time of implant insertion, T1 at 3 months after implant insertion and at T3 at 12 months after implant insertion.
description: Using digital X-ray, bone resorption will be measured using a software in mm.
measure: Probing depth (PD)
time frame: 3, 6,12 months from T0 (Implant insertion)
description: six sites of each implant (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual)
measure: Bleeding on probing (BOP)
time frame: at T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).
description: Binary, Using periodontal probe.
measure: Width of buccal keratinized mucosa (KM)
time frame: 3, 6,12 months from T0 (Implant insertion)
description: Measured at the midbuccal surface of each implant using periodontal probe in mm.
measure: Patient satisfaction (cleaning, food impaction)
time frame: At T2 (6 months after implant insertion) and T3 (12 months after Implant Insertion).
description: Measured using Numerical Rating Scale (NRS) (Kiyak et al, 1984)
arm group label: Cone Morse Connection Implants
arm group type: Experimental
description: 2 neighboring Morse connection Implants
arm group label: platform matched implants
arm group type: Active Comparator
description: 2 neighboring platform matched implants.
intervention type: Combination Product
intervention name: Morse connection Implants
description: 2 neighboring morse connection Implants of Zinedent - Strauman
arm group label: Cone Morse Connection Implants
arm group label: platform matched implants
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nada Zazou, Masters
phone: 02-01224016945
email: drzazou@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nada Zazou
investigator title: Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA).
sharing ipd: Undecided