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/NCT06003322</url>
    </required_header>
    <id_info>
      <org_study_id>PER243</org_study_id>
      <nct_id>NCT06003322</nct_id>
    </id_info>
    <brief_title>Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect</brief_title>
    <official_title>Non - Incised Papilla Versus Single Flap Technique In The Reconstruction Of Intrabony Defect: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Egyptian Russian University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ain Shams 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 present study will aim to assess the effectiveness of the non-Incised Papilla surgical&#xD;
        approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the&#xD;
        single-flap approach SFA.&#xD;
  &#xD;
        Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual&#xD;
        probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip&#xD;
        of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar&#xD;
        attachment gain (SUPRA-AG)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study will aim to assess the effectiveness of the non-Incised Papilla surgical&#xD;
        approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the&#xD;
        single-flap approach SFA.&#xD;
  &#xD;
        Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual&#xD;
        probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip&#xD;
        of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar&#xD;
        attachment gain (SUPRA-AG)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2024</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 (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>interproximal clinical attachment level change</measure>
      <time_frame>at baseline ,6 and 12 months</time_frame>
      <description>CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>residual probing pocket depth (PPD), pocket depth (PD) change,</measure>
      <time_frame>at at baseline ,6 and 12 months</time_frame>
      <description>-Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Periodontal Attachment Loss</condition>
    <arm_group>
      <arm_group_label>non - Incised Papilla surgical approach NIPSA for intrabony defect</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF</description>
    </arm_group>
    <arm_group>
      <arm_group_label>single-flap approach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>non - Incised Papilla surgical approach NIPSA for intrabony defect</intervention_name>
      <description>As described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues.&#xD;
  Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss</description>
      <arm_group_label>non - Incised Papilla surgical approach NIPSA for intrabony defect</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>single-flap approach SFA</intervention_name>
      <description>As described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding).&#xD;
  -A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture</description>
      <arm_group_label>single-flap approach</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  - Age &gt; 18 years&#xD;
  &#xD;
            -  Diagnosis with stage III-IV periodontitis.&#xD;
  &#xD;
            -  Presence of one or more intrabony defects with probing pocket depth (PPD) &gt; 5 mm and&#xD;
               radiographic defect depth &gt; 4 mm.&#xD;
  &#xD;
            -  Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) &lt; 30% (measured at&#xD;
               four sites per tooth).&#xD;
  &#xD;
            -  No relevant systemic condition or disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Third molars and teeth with type III mobility or with an incorrect endodontic or&#xD;
          restorative treatment.&#xD;
  &#xD;
          -&#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>ALAA T ALI, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alaa Ali, P.h.D</last_name>
      <phone>01003646556</phone>
      <email>alaa.ali@dent.aun.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>faculty of dentistry ,Assiut university</name>
        <address>
          <city>Assiut</city>
          <zip>23145</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alaa Ali, Ph.D.</last_name>
        <phone>01003646556</phone>
        <email>alaa.ali@dent.aun.edu.eg</email>
      </contact>
      <investigator>
        <last_name>Aya Ali, Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Alaa Talaat Ali</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontal Attachment 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>
  
  
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/NCT06003322
  org study id: PER243
  nct id: NCT06003322
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The present study will aim to assess the effectiveness of the non-Incised Papilla surgical
        approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the
        single-flap approach SFA.
  
        Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual
        probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip
        of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar
        attachment gain (SUPRA-AG)
  The present study will aim to assess the effectiveness of the non-Incised Papilla surgical
        approach NIPSA used for the surgical debridement of deep intraosseous defects compared to the
        single-flap approach SFA.
  
        Primary outcome: interproximal clinical attachment level gain Secondary outcomes: residual
        probing pocket depth (PPD), pocket depth (PD) reduction, recession (REC), location of the tip
        of the papilla (TP), width of the keratinized tissue (KT), wound closure (WC), supra-alveolar
        attachment gain (SUPRA-AG)
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  measure: interproximal clinical attachment level change
  time frame: at baseline ,6 and 12 months
  description: CAL, measured in the interproximal space from the CEJ to the base of the pocket(BP)using a millimeter periodontal probe
  measure: residual probing pocket depth (PPD), pocket depth (PD) change,
  time frame: at at baseline ,6 and 12 months
  description: -Inter- proximal PD, measured in the interproximal space from the gingival margin to the BP measured by a millimeter periodontal probe
  arm group label: non - Incised Papilla surgical approach NIPSA for intrabony defect
  arm group type: Experimental
  description: Group I will be allocated to non - Incised Papilla surgical approach NIPSA for intrabony defect with DBBM and PRF
  arm group label: single-flap approach
  arm group type: Active Comparator
  description: group II will be allocated to single-flap approach SFA for intrabony defect with DBBM and PRF
  intervention type: Procedure
  intervention name: non - Incised Papilla surgical approach NIPSA for intrabony defect
  description: As described by Rodríguez and Caffesse in 2018, a single incision apical to the defect ,on the buccal aspect, only one apical horizontal or oblique incision will be made in the alveolar mucosa, as far removed as possible from the interdental papillae and marginal keratinized tis- sues.
  Following flap reflection, the bony defect will be examined carefully. Root planing is performed,. Flap closure will be performed by horizontal mattress sutures, placed 3 mm away from the borders, will be used as the first line of closure, promoting connective tissue contact between both edges of the incision, and single interrupted sutures will then be placed as a second line of closure. Using 5/0 polypropylene monofilament suture, Assut, Swiss
  arm group label: non - Incised Papilla surgical approach NIPSA for intrabony defect
  intervention type: Procedure
  intervention name: single-flap approach SFA
  description: As described by Trombelli et al 2010, A horizontal, butt-joint incision will be performed at the interdental papilla 1-2 mm coronal to the bone crest (as detected through pre-operative bone sounding).
  -A buccal mucoperiosteal envelope flap will be elevated by using a microsurgical periosteal elevator, leaving the residual portion of the interdental supracrestal soft tissues undetached.Flap closure will be performed by a horizontal internal mattress suture,will be performed at the base of the papilla, and a second internal mattress suture (vertical or horizontal) was performed between the most coronal portion of the flap and the most coronal portion of the palatal/lingual papilla. Using a resorbable suture
  arm group label: single-flap approach
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: ALAA T ALI, PhD
  role: Study Director
  affiliation: Assiut University
  last name: Alaa Ali, P.h.D
  phone: 01003646556
  email: alaa.ali@dent.aun.edu.eg
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Alaa Talaat Ali
  investigator title: lecturer
  mesh term: Periodontal Attachment Loss
  sharing ipd: No