<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/NCT04449302</url>
  </required_header>
  <id_info>
    <org_study_id>PER 6-3-2</org_study_id>
    <nct_id>NCT04449302</nct_id>
  </id_info>
  <brief_title>Evaluation of Papilla Index Around Immediate Mandibular Molar Implants Using Customized Healing Abutment Versus Submerged Healing</brief_title>
  <official_title>Clinical Evaluation of Papilla Index Around Immediate Implant Placement in Mandibular Molars Using Chairside Customized Healing Abutment Versus Submerged Healing :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>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 original implant treatment protocol recommended that the implant should be placed in a&#xD;
      fully healed site and covered with mucosa after placement to ensure osseointegration. The&#xD;
      reason was to protect the implant site from bacterial contamination and to avoid loading of&#xD;
      the implant. After that, a second stage surgical procedure had to be performed to expose the&#xD;
      implant to connect the abutment. However, it was shown that a one stage or non-submerged (NS)&#xD;
      approach can lead to successful and predictable outcomes.&#xD;
&#xD;
      Customized healing abutments can be used in the non-submerged protocol, protecting and&#xD;
      containing the bone substitute during healing, preserving the alveolar contour, preventing&#xD;
      food impaction, and eliminating the need for a second stage surgery and. By means of this&#xD;
      technique, critical and subcritical contours can be projected speeding up the peri-implant&#xD;
      soft tissue conditioning phase in order to achieve final natural-like restorations.&#xD;
&#xD;
      This randomized controlled trial will compare the clinical and radiographic hard and soft&#xD;
      tissue changes using chairside customized healing abutment versus submerged healing following&#xD;
      immediate implant placement in mandibular molars through measuring the horizontal ridge&#xD;
      changes by CBCT , the crestal bone loss by a standardized digital x-ray and the soft tissue&#xD;
      changes by the pink esthetic score (PES).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immediate implant placement in extraction sockets was used to (i) reduce the number of&#xD;
      surgical procedures (ii) preserve the dimensions of the alveolar ridge and (iii) reduce the&#xD;
      interval between the removal of the tooth and the insertion of the implant supported&#xD;
      restoration.&#xD;
&#xD;
      Flapless extraction is a technique aimed towards leaving the periosteum undisturbed by&#xD;
      extracting the tooth with minimal trauma using periotomes without flap reflection. They also&#xD;
      found less crestal bone loss around immediate implants placed in flapless extraction sockets&#xD;
      in compared to implants placed by elevating a flap, due to greater blood supply and less&#xD;
      postoperative swelling and pain.&#xD;
&#xD;
      Submerged healing and absence of loading was proposed during the early stage of&#xD;
      osseointegration. Such a two-stage approach, based on a period of submerged healing aimed at&#xD;
      optimizing the process of new bone formation and remodeling that follows implant placement is&#xD;
      considered the gold standard procedure. It requires a second surgery to connect the abutment.&#xD;
      This second surgical procedure is generally a minor one; thus, it is not particularly&#xD;
      uncomfortable for the patient and offers the possibility to perform soft tissue management&#xD;
      procedures around healed implants which may result in a better long-term prognosis. On the&#xD;
      other hand, the desire to provide faster and less invasive treatment to patients, as well as&#xD;
      to avoid postponing implant load and prosthesis delivery, has led to one-stage surgery&#xD;
      (non-submerged healing). In this approach the implant and the healing abutment are placed in&#xD;
      a single procedure so it remains exposed in the oral cavity during the osseointegration&#xD;
      period.&#xD;
&#xD;
      The provisional restoration or a custom abutment can act as a &quot;prosthetic socket-sealing&quot; to&#xD;
      protect, contain and maintain the blood clot and bone-graft material during the healing phase&#xD;
      of treatment.&#xD;
&#xD;
      The aim of this randomized clinical trial is to evaluate the clinical and radiographic hard&#xD;
      and soft tissue changes using chairside customized healing abutment versus submerged healing&#xD;
      following immediate implant placement in mandibular molars.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>it is randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>single blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Papilla Index</measure>
    <time_frame>1 year follow up</time_frame>
    <description>JEMT Index (mm.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hard tissue horizontal ridge changes (bucco lingual)</measure>
    <time_frame>1 year follow up</time_frame>
    <description>CBCT (mm.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crestal bone loss</measure>
    <time_frame>1 year follow up</time_frame>
    <description>Standardized periapical Xray (mm.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soft tissue profile</measure>
    <time_frame>1 year follow up</time_frame>
    <description>PES (Pink esthetic score ) Score from 0 to 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction index</measure>
    <time_frame>1 year follow up</time_frame>
    <description>Satisfaction patient questionnaire Score from 0 to 100</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Immediate Dental Implant</condition>
  <arm_group>
    <arm_group_label>Immediate molar implant with customized healing abutment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an immediate mandibular molar implant with customized healing abutment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate molar implant with submerged healing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an immediate mandibular molar implant with submerged healing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate molar implant with customized healing abutment</intervention_name>
    <description>Patients will receive an immediate implant with customized healing abutment&#xD;
Atraumatic extraction without flap elevation using periotomes and elevators then sectioning of the roots will be performed to preserve the interseptal bone.&#xD;
The drilling will be performed starting from the pilot drill in the interseptal bone to the twisting drills according to the manufacturer's instructions to the selected implant size. The implant is to be placed immediately then the insertion torque will be measured using a torque wrench. In order to place the customized healing abutment, the insertion torque should be more than 25 ncm.&#xD;
The gap distance will be filled by xenograft, a plastic abutment will be screwed in place then a flowable composie resin will be applied around into small amounts and cured to take the soft tissue contour then finishing and polishing of the customized healing abutment will be done.</description>
    <arm_group_label>Immediate molar implant with customized healing abutment</arm_group_label>
    <arm_group_label>Immediate molar implant with submerged healing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age between 20 and 70 years old.&#xD;
&#xD;
          -  Patients with non-restorable mandibular molars&#xD;
&#xD;
          -  Medically free.&#xD;
&#xD;
          -  Integrity of the extraction socket wall&#xD;
&#xD;
          -  Patients who are able to sign an informed consent form.&#xD;
&#xD;
          -  Cooperative, motivated and hygiene conscious Patients.&#xD;
&#xD;
          -  Patients who are able to come for the follow up appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with compromised general health conditions that would impair bone healing&#xD;
        including: Past or present history of bone irradiation Patients taking bisphosphonates&#xD;
&#xD;
          -  Teeth with acute periapical pathosis&#xD;
&#xD;
          -  Heavy Smokers&#xD;
&#xD;
          -  Parafunctional habits&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Drug abusers&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omnia Aboul Dahab, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hani El-Nahas, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omnia K. Tawfik, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed N. Ibrahem, Msc</last_name>
    <phone>01004532192</phone>
    <phone_ext>002</phone_ext>
    <email>dr.nabil89@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.</citation>
    <PMID>31797548</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Nabil Ibrahem</investigator_full_name>
    <investigator_title>Teaching assistant</investigator_title>
  </responsible_party>
  <keyword>immediate dental implants</keyword>
  <keyword>customized healing abutment</keyword>
  <keyword>submerged healing</keyword>
  <keyword>papilla index</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>i will check with my study chairs</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/NCT04449302
org study id: PER 6-3-2
nct id: NCT04449302
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The original implant treatment protocol recommended that the implant should be placed in a
      fully healed site and covered with mucosa after placement to ensure osseointegration. The
      reason was to protect the implant site from bacterial contamination and to avoid loading of
      the implant. After that, a second stage surgical procedure had to be performed to expose the
      implant to connect the abutment. However, it was shown that a one stage or non-submerged (NS)
      approach can lead to successful and predictable outcomes.

      Customized healing abutments can be used in the non-submerged protocol, protecting and
      containing the bone substitute during healing, preserving the alveolar contour, preventing
      food impaction, and eliminating the need for a second stage surgery and. By means of this
      technique, critical and subcritical contours can be projected speeding up the peri-implant
      soft tissue conditioning phase in order to achieve final natural-like restorations.

      This randomized controlled trial will compare the clinical and radiographic hard and soft
      tissue changes using chairside customized healing abutment versus submerged healing following
      immediate implant placement in mandibular molars through measuring the horizontal ridge
      changes by CBCT , the crestal bone loss by a standardized digital x-ray and the soft tissue
      changes by the pink esthetic score (PES).
Immediate implant placement in extraction sockets was used to (i) reduce the number of
      surgical procedures (ii) preserve the dimensions of the alveolar ridge and (iii) reduce the
      interval between the removal of the tooth and the insertion of the implant supported
      restoration.

      Flapless extraction is a technique aimed towards leaving the periosteum undisturbed by
      extracting the tooth with minimal trauma using periotomes without flap reflection. They also
      found less crestal bone loss around immediate implants placed in flapless extraction sockets
      in compared to implants placed by elevating a flap, due to greater blood supply and less
      postoperative swelling and pain.

      Submerged healing and absence of loading was proposed during the early stage of
      osseointegration. Such a two-stage approach, based on a period of submerged healing aimed at
      optimizing the process of new bone formation and remodeling that follows implant placement is
      considered the gold standard procedure. It requires a second surgery to connect the abutment.
      This second surgical procedure is generally a minor one; thus, it is not particularly
      uncomfortable for the patient and offers the possibility to perform soft tissue management
      procedures around healed implants which may result in a better long-term prognosis. On the
      other hand, the desire to provide faster and less invasive treatment to patients, as well as
      to avoid postponing implant load and prosthesis delivery, has led to one-stage surgery
      (non-submerged healing). In this approach the implant and the healing abutment are placed in
      a single procedure so it remains exposed in the oral cavity during the osseointegration
      period.

      The provisional restoration or a custom abutment can act as a "prosthetic socket-sealing" to
      protect, contain and maintain the blood clot and bone-graft material during the healing phase
      of treatment.

      The aim of this randomized clinical trial is to evaluate the clinical and radiographic hard
      and soft tissue changes using chairside customized healing abutment versus submerged healing
      following immediate implant placement in mandibular molars.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: it is randomized clinical trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: single blinded
measure: Papilla Index
time frame: 1 year follow up
description: JEMT Index (mm.)
measure: Hard tissue horizontal ridge changes (bucco lingual)
time frame: 1 year follow up
description: CBCT (mm.)
measure: Crestal bone loss
time frame: 1 year follow up
description: Standardized periapical Xray (mm.)
measure: Soft tissue profile
time frame: 1 year follow up
description: PES (Pink esthetic score ) Score from 0 to 14
measure: Satisfaction index
time frame: 1 year follow up
description: Satisfaction patient questionnaire Score from 0 to 100
arm group label: Immediate molar implant with customized healing abutment
arm group type: Experimental
description: Patients will receive an immediate mandibular molar implant with customized healing abutment
arm group label: Immediate molar implant with submerged healing
arm group type: Active Comparator
description: Patients will receive an immediate mandibular molar implant with submerged healing
intervention type: Procedure
intervention name: Immediate molar implant with customized healing abutment
description: Patients will receive an immediate implant with customized healing abutment
Atraumatic extraction without flap elevation using periotomes and elevators then sectioning of the roots will be performed to preserve the interseptal bone.
The drilling will be performed starting from the pilot drill in the interseptal bone to the twisting drills according to the manufacturer's instructions to the selected implant size. The implant is to be placed immediately then the insertion torque will be measured using a torque wrench. In order to place the customized healing abutment, the insertion torque should be more than 25 ncm.
The gap distance will be filled by xenograft, a plastic abutment will be screwed in place then a flowable composie resin will be applied around into small amounts and cured to take the soft tissue contour then finishing and polishing of the customized healing abutment will be done.
arm group label: Immediate molar implant with customized healing abutment
arm group label: Immediate molar implant with submerged healing
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Omnia Aboul Dahab, Phd
role: Study Chair
affiliation: Cairo University
last name: Hani El-Nahas, Phd
role: Study Chair
affiliation: Cairo University
last name: Omnia K. Tawfik, Phd
role: Study Chair
affiliation: Cairo University
last name: Mohamed N. Ibrahem, Msc
phone: 01004532192
phone ext: 002
email: dr.nabil89@gmail.com
citation: Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.
PMID: 31797548
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Nabil Ibrahem
investigator title: Teaching assistant
sharing ipd: Undecided
ipd description: i will check with my study chairs