<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/NCT04444063</url>
  </required_header>
  <id_info>
    <org_study_id>PER 3-3-3</org_study_id>
    <nct_id>NCT04444063</nct_id>
  </id_info>
  <brief_title>Clinical and Radiograhic Evaluation of NIPSA With and Without Allograft Plus Platelet Rich Fibrin in the Treatment of Intraosseous Defects in Stage III Periodontitis Patients</brief_title>
  <official_title>Clinical and Radiographic Evaluation of the Non-Incised Papilla Surgical Approach With and Without Allograft Plus Platelet Rich Fibrin in Treatment of Intraosseous Defects in Stage III Periodontitis Patients: 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>
      Several minimal invasive techniques have been proposed since the last decade aiming to&#xD;
      enhance and provide adequate environment for periodontal regeneration. Harrel and Rees&#xD;
      proposed minimally invasive surgery (MIS) in 1995 and minimal invasive surgical technique&#xD;
      (MIST) that was introduced in 2007 and then further enforced with modified minimally invasive&#xD;
      surgical technique (M-MIST) in 2009 . A new minimal invasive technique called Non-Incised&#xD;
      Papilla Surgical Approach (NIPSA) was introduced in 2017. It is aims to maintain the marginal&#xD;
      tissues integrity by placing horizontal or oblique incision apical to the defect approaching&#xD;
      the defect through apical access.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intraosseous vertical defects are one of the consequences that could result from&#xD;
      periodontitis, which are classified according to their architecture by the number of residual&#xD;
      walls, defect width as well as topographic extension in relation to the tooth.&#xD;
&#xD;
      Conventional surgery done for regenerative purpose regarding vertical defects has been known&#xD;
      to be affected by clot stability, it was reported in the literature that reduced clinical&#xD;
      outcomes occurred when early wound failure and exposure of the treated area occurred. This&#xD;
      led to the innovation of different minimally invasive flap techniques that aimed at reducing&#xD;
      the surgical trauma, allowing blood clot stability, protecting the regenerating site,&#xD;
      reducing patient discomfort postoperatively as well as minimizing surgical chair time Among&#xD;
      these techniques are papilla preservation flaps and minimally invasive surgical approaches&#xD;
      with papilla elevation or without papilla elevation . However, these techniques had in their&#xD;
      design incisions related to the interdental papilla which would jeopardize and complicate the&#xD;
      vascular integrity of the interdental tissues Non incised Papilla surgical approach is a new&#xD;
      surgical technique introduced by Moreno Rodriguez in 2017 to maintain the marginal tissues&#xD;
      and the papilla intact by placing a horizontal or oblique incision apical to the defect and&#xD;
      approaching it through an apical access leaving the marginal tissues to act as a &quot;dome &quot;&#xD;
      protecting the blood clot&#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 a 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>Clinical attachment level gain (CAL) clinical attachment level gain (CAL)</measure>
    <time_frame>12 months</time_frame>
    <description>measured with UNC periodontal probe in mm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival recession (GR)</measure>
    <time_frame>12 months</time_frame>
    <description>measured with UNC periodontal probe in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket depth (PD)</measure>
    <time_frame>12 months</time_frame>
    <description>measured with UNC periodontal probe in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic defect fill</measure>
    <time_frame>12 months</time_frame>
    <description>standardized digital periapical radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival bleeding</measure>
    <time_frame>T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical</time_frame>
    <description>Gingival bleeding score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>12 months</time_frame>
    <description>Plaque Index score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-surgical patient Satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>(1-7) point scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Periodontitis Chronic Generalized Severe</condition>
  <condition>Intrabony Periodontal Defect</condition>
  <arm_group>
    <arm_group_label>NIPSA technique with Allograft plus PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIPSA technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-Incised Papilla Surgical Approach</intervention_name>
    <description>Horizontal or oblique incision is done on the buccal mucosa as far as possible from the marginal keratinized tissue and the inter dental papilla The horizontal/oblique incision is extended mesio-distally enough to allow proper visualization of the defect A full thickness flap is elevated apico- coronally to expose the coronal limit of the defect Scaling and root planning are done using mini-curettes and power driven ultrasonic tips with care trying to maintain fibers attached to the cementum Granulation tissue is removed with mini-curettes detached from the bony walls and removed from the base of the papilla carefully with microblades and microscissors .&#xD;
1ry soft tissue closure will be performed by horizontal mattress suture 2mm from the edges of the incision as a first line of closure and then simple interrupted suture as a second line of closure using (5-0, 6-0) polypropylene suture.</description>
    <arm_group_label>NIPSA technique</arm_group_label>
    <arm_group_label>NIPSA technique with Allograft plus PRF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Stage III periodontitis patient having at least one tooth with two wall&#xD;
             or combined two to three walled intraosseous defect more than or equal 3 mm deep&#xD;
             (assessed by trans-gingival probing, radiographic examination) with clinical&#xD;
             attachment level (CAL) more than or equal 5mm and pocket depth (PD) more than or equal&#xD;
             6 mm.&#xD;
&#xD;
          -  Defect not extending to a root furcation area.&#xD;
&#xD;
          -  Vital teeth&#xD;
&#xD;
          -  No history of intake of antibiotics or other medications affecting the periodontium in&#xD;
             the previous 6 months.&#xD;
&#xD;
          -  No surgical periodontal therapy carried out in the past 6 months.&#xD;
&#xD;
          -  Able to sign an informed consent form.&#xD;
&#xD;
          -  Patients who are cooperative, motivated, and hygiene conscious.&#xD;
&#xD;
          -  Able to come for the follow up appointment's needed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic disease that contra-indicates periodontal surgery or may affect healing.&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Drug abusers&#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>Omneya Abo-Eldahab, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omneya K. Tawfeek, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed M. Elkady, MSc</last_name>
    <phone>01005641154</phone>
    <phone_ext>002</phone_ext>
    <email>ahmedelkady442@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.</citation>
    <PMID>31190409</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed mohamed Ibrahim Elkady</investigator_full_name>
    <investigator_title>Teaching Assistant</investigator_title>
  </responsible_party>
  <keyword>minimal invasive technique</keyword>
  <keyword>NIPSA</keyword>
  <keyword>Allograft</keyword>
  <keyword>PRF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <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/NCT04444063
org study id: PER 3-3-3
nct id: NCT04444063
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Several minimal invasive techniques have been proposed since the last decade aiming to
      enhance and provide adequate environment for periodontal regeneration. Harrel and Rees
      proposed minimally invasive surgery (MIS) in 1995 and minimal invasive surgical technique
      (MIST) that was introduced in 2007 and then further enforced with modified minimally invasive
      surgical technique (M-MIST) in 2009 . A new minimal invasive technique called Non-Incised
      Papilla Surgical Approach (NIPSA) was introduced in 2017. It is aims to maintain the marginal
      tissues integrity by placing horizontal or oblique incision apical to the defect approaching
      the defect through apical access.
Intraosseous vertical defects are one of the consequences that could result from
      periodontitis, which are classified according to their architecture by the number of residual
      walls, defect width as well as topographic extension in relation to the tooth.

      Conventional surgery done for regenerative purpose regarding vertical defects has been known
      to be affected by clot stability, it was reported in the literature that reduced clinical
      outcomes occurred when early wound failure and exposure of the treated area occurred. This
      led to the innovation of different minimally invasive flap techniques that aimed at reducing
      the surgical trauma, allowing blood clot stability, protecting the regenerating site,
      reducing patient discomfort postoperatively as well as minimizing surgical chair time Among
      these techniques are papilla preservation flaps and minimally invasive surgical approaches
      with papilla elevation or without papilla elevation . However, these techniques had in their
      design incisions related to the interdental papilla which would jeopardize and complicate the
      vascular integrity of the interdental tissues Non incised Papilla surgical approach is a new
      surgical technique introduced by Moreno Rodriguez in 2017 to maintain the marginal tissues
      and the papilla intact by placing a horizontal or oblique incision apical to the defect and
      approaching it through an apical access leaving the marginal tissues to act as a "dome "
      protecting the blood clot
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: it is a Randomized clinical trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: single blinded
measure: Clinical attachment level gain (CAL) clinical attachment level gain (CAL)
time frame: 12 months
description: measured with UNC periodontal probe in mm
measure: Gingival recession (GR)
time frame: 12 months
description: measured with UNC periodontal probe in mm
measure: Pocket depth (PD)
time frame: 12 months
description: measured with UNC periodontal probe in mm
measure: Radiographic defect fill
time frame: 12 months
description: standardized digital periapical radiograph
measure: Gingival bleeding
time frame: T1 T2 (Surgical phase- 8 weeks) , T4 3- months post-surgical ,T5 6-months post-surgical ,T6 1- Year post-surgical
description: Gingival bleeding score
measure: Plaque index
time frame: 12 months
description: Plaque Index score
measure: Post-surgical patient Satisfaction
time frame: 12 months
description: (1-7) point scale
arm group label: NIPSA technique with Allograft plus PRF
arm group type: Experimental
description: Non-incised papilla preservation technique to treat intraosseous bony defects with the addition of Allograft plus PRF
arm group label: NIPSA technique
arm group type: Active Comparator
description: Non-incised papilla preservation technique to treat intraosseous bony defects without the addition of Allograft plus PRF
intervention type: Procedure
intervention name: Non-Incised Papilla Surgical Approach
description: Horizontal or oblique incision is done on the buccal mucosa as far as possible from the marginal keratinized tissue and the inter dental papilla The horizontal/oblique incision is extended mesio-distally enough to allow proper visualization of the defect A full thickness flap is elevated apico- coronally to expose the coronal limit of the defect Scaling and root planning are done using mini-curettes and power driven ultrasonic tips with care trying to maintain fibers attached to the cementum Granulation tissue is removed with mini-curettes detached from the bony walls and removed from the base of the papilla carefully with microblades and microscissors .
1ry soft tissue closure will be performed by horizontal mattress suture 2mm from the edges of the incision as a first line of closure and then simple interrupted suture as a second line of closure using (5-0, 6-0) polypropylene suture.
arm group label: NIPSA technique
arm group label: NIPSA technique with Allograft plus PRF
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Omneya Abo-Eldahab, PHD
role: Study Chair
affiliation: Cairo University
last name: Omneya K. Tawfeek, PHD
role: Study Chair
affiliation: Cairo University
last name: Ahmed M. Elkady, MSc
phone: 01005641154
phone ext: 002
email: ahmedelkady442@gmail.com
citation: Moreno Rodriguez JA, Ortiz Ruiz AJ, Caffesse RG. Supra-alveolar attachment gain in the treatment of combined intra-suprabony periodontal defects by non-incised papillae surgical approach. J Clin Periodontol. 2019 Sep;46(9):927-936. doi: 10.1111/jcpe.13158. Epub 2019 Jul 22.
PMID: 31190409
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed mohamed Ibrahim Elkady
investigator title: Teaching Assistant
mesh term: Periodontitis
sharing ipd: Undecided
ipd description: I will check with my study chairs