<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/NCT03804086</url>
  </required_header>
  <id_info>
    <org_study_id>perio2019</org_study_id>
    <nct_id>NCT03804086</nct_id>
  </id_info>
  <brief_title>Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects</brief_title>
  <official_title>Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadeer Ashraf Hassan Roushdy</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>
      this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline&#xD;
      hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap&#xD;
      debridement alone in the management of mandibular molar grade II defects.&#xD;
&#xD;
      In the management of mandibular molar grade II furcation defects, no difference exists in&#xD;
      gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin&#xD;
      (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap&#xD;
      debridement (OPD) and open flap debridement (OPD) alone .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relative Vertical Clinical Attachment Level (RVCAL)</measure>
    <time_frame>6 months</time_frame>
    <description>relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relative Horizontal Clinical Attachment Level (PHCAL)</measure>
    <time_frame>6 months</time_frame>
    <description>relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing Depth (PD)</measure>
    <time_frame>6 months</time_frame>
    <description>Probing depth measured from the gingival margin to the base of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival margin Level (GML)</measure>
    <time_frame>6 months</time_frame>
    <description>• Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open flap debridement alone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement</intervention_name>
    <description>will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant.&#xD;
The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature.&#xD;
After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.</description>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open flap debridement</intervention_name>
    <description>a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient-related criteria:&#xD;
&#xD;
          -  Systemically healthy patients.&#xD;
&#xD;
          -  Compliance with oral hygiene instructions and the maintenance program provided.&#xD;
&#xD;
          -  Accepts the 6 months follow-up period.&#xD;
&#xD;
          -  Provide informed consent.&#xD;
&#xD;
        Teeth related criteria:&#xD;
&#xD;
          -  Mature permanent tooth.&#xD;
&#xD;
          -  Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.&#xD;
&#xD;
          -  Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and&#xD;
             root planing).&#xD;
&#xD;
          -  Presence of radiolucency in the furcation area on an intra-oral periapical radiograph&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient-related criteria:&#xD;
&#xD;
          -  Patients taking drugs known to interfere with periodontal wound healing in the last&#xD;
             six months.&#xD;
&#xD;
          -  Pregnant or nursing women.&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Uncooperative patients.&#xD;
&#xD;
        Teeth related criteria:&#xD;
&#xD;
          -  Teeth with interproximal supra-bony or intrabony defects.&#xD;
&#xD;
          -  Teeth with gingival recession.&#xD;
&#xD;
          -  Teeth with grade II or III mobility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hadeer Ashraf Hassan Roushdy</investigator_full_name>
    <investigator_title>Dentist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Furcation Defects</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/NCT03804086
org study id: perio2019
nct id: NCT03804086
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline
      hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap
      debridement alone in the management of mandibular molar grade II defects.

      In the management of mandibular molar grade II furcation defects, no difference exists in
      gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin
      (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap
      debridement (OPD) and open flap debridement (OPD) alone .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relative Vertical Clinical Attachment Level (RVCAL)
time frame: 6 months
description: relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
measure: Relative Horizontal Clinical Attachment Level (PHCAL)
time frame: 6 months
description: relative vertical clinical attachment level (RVCAL) along with gingival marginal level (GML) will be measured from the apical level of customized acrylic stents with grooves to ensure a reproducible placement of a periodontal probe
measure: Probing Depth (PD)
time frame: 6 months
description: Probing depth measured from the gingival margin to the base of the pocket.
measure: Gingival margin Level (GML)
time frame: 6 months
description: • Williams graduated probe will be used for vertical measurement and gingival margin level and Nabers probe for horizontal measurements.
arm group label: Test Group
arm group type: Experimental
description: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OFD).
arm group label: Control Group
arm group type: Active Comparator
description: Open flap debridement alone.
intervention type: Procedure
intervention name: Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement
description: will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant.
The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature.
After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze.
arm group label: Test Group
intervention type: Procedure
intervention name: Open flap debridement
description: a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.
arm group label: Control Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Hadeer Ashraf Hassan Roushdy
investigator title: Dentist
mesh term: Periodontitis
mesh term: Furcation Defects
sharing ipd: Undecided