<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/NCT03839849</url>
  </required_header>
  <id_info>
    <org_study_id>SPU-DN-Perio-1</org_study_id>
    <nct_id>NCT03839849</nct_id>
  </id_info>
  <brief_title>Evaluation of Adjunctive Injectable PRF Therapy Used in Conjunction With Scaling and Root Planning</brief_title>
  <official_title>Clinical Effectiveness of a Topical Subgingival Application of Injectable Platelet-rich Fibrin as Adjunctive Therapy to Scaling and Root Planing. A Double-blind Split Mouth Randomized Prospective Comparative Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syrian Private University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Syrian Private 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>
      Clinical evaluation of local administration of injectable PRF (injectable platelet-rich&#xD;
      fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15&#xD;
      periodontal patients will receive a through traditional mechanical treatment (scaling and&#xD;
      root planing). Each patient will receive subgingival i-PRF injected in half mouth and the&#xD;
      opposite side will be injected with saline, immediately after the deep scaling session.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after&#xD;
      scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15&#xD;
      periodontal patients will receive traditional mechanical supra and subgingival scaling and&#xD;
      root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design.&#xD;
      The injected half mouth (study group) for each patient will be allocated randomly. The&#xD;
      opposite side will be injected with saline (control group). Clinical parameters will be&#xD;
      evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical&#xD;
      attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2019</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical attachment level (CAL)</measure>
    <time_frame>baseline, 2 months</time_frame>
    <description>measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 &quot;University of North Carolina&quot;)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Probing pocket depth (PD)</measure>
    <time_frame>baseline, 2 months</time_frame>
    <description>measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 &quot;University of North Carolina&quot;)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)</measure>
    <time_frame>baseline, 2 months</time_frame>
    <description>0 No plaque&#xD;
Separate flecks of plaque at the cervical margin of the tooth&#xD;
A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth&#xD;
A band of plaque wider than one mm but covering less than one-third of the crown of the tooth&#xD;
Plaque covering at least one-third but less than two-thirds of the crown of the tooth&#xD;
Plaque covering two-thirds or more of the crown of the tooth labial/ buccal and lingual surfaces are assessed after using disclosing solution.&#xD;
An index for the entire mouth is determined by dividing the total score by the number surfaces examined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Gingival Index (Trombelli et al. 2004)</measure>
    <time_frame>baseline, 2 months</time_frame>
    <description>0 = Normal gingiva;&#xD;
= Mild inflammation - slight change in color and slight edema;&#xD;
= Moderate inflammation - redness, edema and glazing;&#xD;
= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.&#xD;
will be evaluated visually</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing (BOP)</measure>
    <time_frame>baseline, 2 months</time_frame>
    <description>All six sites of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage.&#xD;
- no bleeding upon probing (not recorded)&#xD;
+ bleeding upon probing&#xD;
Calculation:&#xD;
BOP= Number of bleeding sites x100/ Number of sites evaluated will be evaluated visually and used a UNC-15 mm &quot;University of North Carolina&quot; periodontal probe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Periodontal Pockets</condition>
  <arm_group>
    <arm_group_label>i-PRF (Test)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>injected subgingivally i-PRF after scaling and root planing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>injected subgingivally saline after scaling and root planing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>: i-PRF</intervention_name>
    <description>The description of this intervention has been already given before</description>
    <arm_group_label>i-PRF (Test)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>The description of this intervention has been already given before</description>
    <arm_group_label>saline (Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are in general good health.&#xD;
&#xD;
          -  Patients are from both gender and are adult.&#xD;
&#xD;
          -  A sign informed consent from participation and permission to use obtained data for&#xD;
             research purposes.&#xD;
&#xD;
          -  They have not taken medication known to interfere with periodontal tissue health or&#xD;
             healing in the preceding 6 months.&#xD;
&#xD;
          -  Presence of bilateral periodontal pockets (≥5 mm) on the minimum of 2 teeth in each&#xD;
             side.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years' old&#xD;
&#xD;
          -  Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…)&#xD;
&#xD;
          -  clotting and Hematological disorders&#xD;
&#xD;
          -  Medications influence on the gingival and periodontal tissues (like calcium channel&#xD;
             blockers, or Long-term steroid use&#xD;
&#xD;
          -  The teeth with poor bad filling and poorly fitted restorations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hala Albonni, DDS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Syrian Private University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hazem Sawaf, DDS MSc PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Syrian Private University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syrian Private University</name>
      <address>
        <city>Damascus</city>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.</citation>
    <PMID>28154995</PMID>
  </reference>
  <reference>
    <citation>Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.</citation>
    <PMID>30003342</PMID>
  </reference>
  <reference>
    <citation>Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Effects of an injectable platelet-rich fibrin on osteoblast behavior and bone tissue formation in comparison to platelet-rich plasma. Platelets. 2018 Jan;29(1):48-55. doi: 10.1080/09537104.2017.1293807. Epub 2017 Mar 29.</citation>
    <PMID>28351189</PMID>
  </reference>
  <reference>
    <citation>Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Behavior of Gingival Fibroblasts on Titanium Implant Surfaces in Combination with either Injectable-PRF or PRP. Int J Mol Sci. 2017 Feb 4;18(2):331. doi: 10.3390/ijms18020331.</citation>
    <PMID>28165420</PMID>
  </reference>
  <reference>
    <citation>Kour P, Pudakalkatti PS, Vas AM, Das S, Padmanabhan S. Comparative Evaluation of Antimicrobial Efficacy of Platelet-rich Plasma, Platelet-rich Fibrin, and Injectable Platelet-rich Fibrin on the Standard Strains of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S325-S330. doi: 10.4103/ccd.ccd_367_18.</citation>
    <PMID>30294166</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>periodontal pockets</keyword>
  <keyword>injectable platelet-rich fibrin</keyword>
  <keyword>saline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Pocket</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03839849
org study id: SPU-DN-Perio-1
nct id: NCT03839849
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical evaluation of local administration of injectable PRF (injectable platelet-rich
      fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15
      periodontal patients will receive a through traditional mechanical treatment (scaling and
      root planing). Each patient will receive subgingival i-PRF injected in half mouth and the
      opposite side will be injected with saline, immediately after the deep scaling session.
The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after
      scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15
      periodontal patients will receive traditional mechanical supra and subgingival scaling and
      root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design.
      The injected half mouth (study group) for each patient will be allocated randomly. The
      opposite side will be injected with saline (control group). Clinical parameters will be
      evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical
      attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Clinical attachment level (CAL)
time frame: baseline, 2 months
description: measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
measure: Probing pocket depth (PD)
time frame: baseline, 2 months
description: measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
measure: full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970)
time frame: baseline, 2 months
description: 0 No plaque
Separate flecks of plaque at the cervical margin of the tooth
A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth
A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
Plaque covering at least one-third but less than two-thirds of the crown of the tooth
Plaque covering two-thirds or more of the crown of the tooth labial/ buccal and lingual surfaces are assessed after using disclosing solution.
An index for the entire mouth is determined by dividing the total score by the number surfaces examined.
measure: Modified Gingival Index (Trombelli et al. 2004)
time frame: baseline, 2 months
description: 0 = Normal gingiva;
= Mild inflammation - slight change in color and slight edema;
= Moderate inflammation - redness, edema and glazing;
= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
will be evaluated visually
measure: Bleeding on probing (BOP)
time frame: baseline, 2 months
description: All six sites of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage.
- no bleeding upon probing (not recorded)
+ bleeding upon probing
Calculation:
BOP= Number of bleeding sites x100/ Number of sites evaluated will be evaluated visually and used a UNC-15 mm "University of North Carolina" periodontal probe
arm group label: i-PRF (Test)
arm group type: Experimental
description: injected subgingivally i-PRF after scaling and root planing
arm group label: saline (Control)
arm group type: Active Comparator
description: injected subgingivally saline after scaling and root planing
intervention type: Procedure
intervention name: : i-PRF
description: The description of this intervention has been already given before
arm group label: i-PRF (Test)
intervention type: Procedure
intervention name: saline
description: The description of this intervention has been already given before
arm group label: saline (Control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hala Albonni, DDS MSc
role: Principal Investigator
affiliation: Syrian Private University
last name: Hazem Sawaf, DDS MSc PhD
role: Study Chair
affiliation: Syrian Private University
facility: 
country: Syrian Arab Republic
citation: Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
PMID: 28154995
citation: Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.
PMID: 30003342
citation: Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Effects of an injectable platelet-rich fibrin on osteoblast behavior and bone tissue formation in comparison to platelet-rich plasma. Platelets. 2018 Jan;29(1):48-55. doi: 10.1080/09537104.2017.1293807. Epub 2017 Mar 29.
PMID: 28351189
citation: Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Behavior of Gingival Fibroblasts on Titanium Implant Surfaces in Combination with either Injectable-PRF or PRP. Int J Mol Sci. 2017 Feb 4;18(2):331. doi: 10.3390/ijms18020331.
PMID: 28165420
citation: Kour P, Pudakalkatti PS, Vas AM, Das S, Padmanabhan S. Comparative Evaluation of Antimicrobial Efficacy of Platelet-rich Plasma, Platelet-rich Fibrin, and Injectable Platelet-rich Fibrin on the Standard Strains of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S325-S330. doi: 10.4103/ccd.ccd_367_18.
PMID: 30294166
responsible party type: Sponsor
mesh term: Periodontal Pocket
sharing ipd: No