<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/NCT02982681</url>
  </required_header>
  <id_info>
    <org_study_id>SUG/25/2015</org_study_id>
    <nct_id>NCT02982681</nct_id>
  </id_info>
  <brief_title>Bioactive Glass and Platelet Rich Fibrin in Intrabony Defects</brief_title>
  <official_title>COMPARATIVE EVALUATION OF BIOACTIVE GLASS PUTTY AND PLATELET RICH FIBRIN IN THE TREATMENT OF HUMAN PERIODONTAL INTRABONY DEFECTS- A CLINICAL AND RADIOGRAPHICAL STUDY&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. D. Y. Patil Dental College &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Santosh University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr. D. Y. Patil Dental College &amp; Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be&#xD;
      effective in promoting reduction in probing depth, gain in clinical attachment, and defect&#xD;
      fill in intrabony periodontal defects. The individual role played by bioactive glass putty in&#xD;
      combination with PRF is yet to be elucidated.&#xD;
&#xD;
      AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and&#xD;
      Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects&#xD;
      in humans.&#xD;
&#xD;
      Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and&#xD;
      Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on&#xD;
      other side. The primary outcomes of the study included changes in probing depth, attachment&#xD;
      level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3,&#xD;
      6, and 9 months. Radiographic assessment was done using standardized intra oral periapical&#xD;
      radiographs. Comparisions were made within each group between baseline, 3 months, 6 months&#xD;
      and 9 months using the ANOVA test followed by Bonferroni test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION&#xD;
&#xD;
      Periodontitis is an infectious disease that causes destruction of the attachment&#xD;
      apparatus.[1].The mainstay aim of periodontal treatment is the regeneration of the lost&#xD;
      attachment apparatus of the teeth. Variety of treatment modalities are available for&#xD;
      periodontal regenerative therapy including bone grafts, bone substitutes, Guided Tissue&#xD;
      Regeneration, growth factors, application of tissue engineering or the combination of two or&#xD;
      more of the above listed approaches. [2] Alloplasts, may be an effective alternative to&#xD;
      allograft and xenografts as there is no risk of disease transmission and the supply is&#xD;
      unlimited.[3] The Bioactive glass promotes osteogenesis by adsorption and concentrations of&#xD;
      protein utilized by osteoblast to form a mineralized extracellular matrix. [4] The advantage&#xD;
      of the putty form of bioactive glass is the glycerine and polyethylene glycol which makes the&#xD;
      glass particle coherent and thus enhancing handling characteristics and minimal migration of&#xD;
      graft particles from the defect site. [5] Histological evaluation of material has shown that&#xD;
      the particulate tends to retard the down growth of epithelial tissue. [6,7,8,9] Growth&#xD;
      factors play a pivotal role in periodontal regeneration. Platelet Rich Fibrin is believed to&#xD;
      release polypeptide growth factors, such as transforming growth factors-ß, platelet derived&#xD;
      growth factors, vascular endothelial growth factors and matrix glycoproteins (such as&#xD;
      thrombospondin -1) into the surgical wound in a sustained fashion for at least 7 days as&#xD;
      shown in vitro. [10] Thus, given the unique graft with osteoconductive, osteoinductive and&#xD;
      osteostimulative properties and properties of autologous PRF, application of combination&#xD;
      approach was attempted for the assessment of their additional benefits to the healing&#xD;
      mechanisms and periodontal regeneration in intrabony defects.&#xD;
&#xD;
      Materials and methods Patient Selection This randomized control trial was carried out in the&#xD;
      Department of Periodontics and Oral Implantology, Santosh Dental College and Hospital,&#xD;
      Santosh University, Ghaziabad. Ten patients suffering chronic localized periodontitis aged&#xD;
      between 20 -50 years (7 males and 3 females) with 10 pairs of contalateral intraosseous&#xD;
      defects (n=20) comprised the study population. A total of 20 bone defects (10 pairs) were&#xD;
      decided by the statisticion to be of statistical strength. Convenient sampling design was&#xD;
      used for the enrolment of study patients. Ethical approval was taken from the institutional&#xD;
      ethical committee The patients were explained in detail about the procedure and a written&#xD;
      informed consent was taken. The intrabony defects were diagnosed clinically with moderate to&#xD;
      deep periodontal pockets &gt; or = 5mm and with clinical and radiographic evidence of&#xD;
      vertical/angular osseous defects. [3] Patients with systemic diseases, on anticoagulants,&#xD;
      those with habit of smoking and alcohol, with known history of allergy to graft material and&#xD;
      who have undergone periodontal surgical treatment for chronic periodontitis within twelve&#xD;
      months for the same defects were excluded from the study.&#xD;
&#xD;
      PRESURGICAL THERAPY Patients underwent phase I therapy. The selected defects were evaluated&#xD;
      after 2 weeks, and persistent pockets &gt; or = 5mm and patients with clinical radiographic&#xD;
      evidence of angular osseous defects were scheduled for surgery.&#xD;
&#xD;
      Clinical Parameters :&#xD;
&#xD;
      Oral hygiene status was recorded using the gingival index of Loe &amp; Sillness,[11];&#xD;
&#xD;
      with score 0 indicating absence of inflammation and score 3 indicating severe&#xD;
&#xD;
      inflammation and plaque index of Silness &amp; Loe. [12]&#xD;
&#xD;
      Probing pocket depth and Clinical attachment level were recorded at baseline on the&#xD;
&#xD;
      day of surgery, 3, 6 and 9 months intervals using UNC-15 probe and customized&#xD;
&#xD;
      acrylic occlusal stents grooved in the area of defect to provide reproducible insertion&#xD;
&#xD;
      axis-&#xD;
&#xD;
      The following measurements were recorded with customized&#xD;
&#xD;
      acrylic stent:&#xD;
&#xD;
        -  Fixed reference point (FRP) to the base of pocket (BP)&#xD;
&#xD;
        -  Fixed reference point (FRP) to the cemento-enamel junction (CEJ)&#xD;
&#xD;
        -  Fixed reference point (FRP) to the gingival margin (GM)&#xD;
&#xD;
      PPD and CAL were calculated from these probing measurements as:&#xD;
&#xD;
        -  PPD = (FRP to BP) - (FRP to GM)&#xD;
&#xD;
        -  CAL= (FRP to BP) - (FRP to CEJ)&#xD;
&#xD;
      Radiographic measurements: Standardized intra-oral periapical radiographs of the defects were&#xD;
      taken using a paralleling technique.[13]&#xD;
&#xD;
      Amount of defect fill: Defects were measured from the fixed reference point (distance between&#xD;
      the cemento-enamel junction to the radiographic base of the bone defect ) with the help of&#xD;
      1.1 mm grid and the following radiographic features were recorded on the day of surgery, 3, 6&#xD;
      and 9 months intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 3</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intrabony defect fill</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>change in intrabony defect fill from baseline to 9 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>change in probing depth from baseline to 9 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>change in Clinical attachment level from baseline to 9 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Index</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>change in Gingival Index from baseline to 9 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Periodontal Diseases</condition>
  <condition>Bone Resorption</condition>
  <arm_group>
    <arm_group_label>Platelet rich Fibrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bioactive glass</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Platelet rich fibrin</intervention_name>
    <description>In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site</description>
    <arm_group_label>Platelet rich Fibrin</arm_group_label>
    <other_name>PRF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bioactive Glass</intervention_name>
    <description>The control site were packed with the bioactive glass graft alone</description>
    <arm_group_label>Bioactive glass</arm_group_label>
    <other_name>Novabone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The intrabony defects were diagnosed clinically with moderate to deep periodontal&#xD;
             pockets &gt; or = 5mm and with clinical and radiographic evidence of vertical/angular&#xD;
             osseous defects.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic diseases, on anticoagulants, those with habit of smoking and&#xD;
             alcohol, with known history of allergy to graft material and who have undergone&#xD;
             periodontal surgical treatment for chronic periodontitis within twelve months for the&#xD;
             same defects were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Hall EE, Meffert RM, Hermann JS, Mellonig JT, Cochran DL. Comparison of bioactive glass to demineralized freeze-dried bone allograft in the treatment of intrabony defects around implants in the canine mandible. J Periodontol. 1999 May;70(5):526-35. doi: 10.1902/jop.1999.70.5.526.</citation>
    <PMID>10368057</PMID>
  </reference>
  <reference>
    <citation>Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.</citation>
    <PMID>19089687</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. D. Y. Patil Dental College &amp; Hospital</investigator_affiliation>
    <investigator_full_name>Santosh Martande</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Periodontal disease</keyword>
  <keyword>Platelet rich fibrin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Resorption</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02982681
org study id: SUG/25/2015
nct id: NCT02982681
lead sponsor: 
collaborator: 
has dmc: Yes
Background: Platelet-rich fibrin (PRF) and bioactive glass putty has been shown to be
      effective in promoting reduction in probing depth, gain in clinical attachment, and defect
      fill in intrabony periodontal defects. The individual role played by bioactive glass putty in
      combination with PRF is yet to be elucidated.

      AIM: To compare the clinical effectiveness of the combination of Plaltelet Rich Fibrin and
      Bioactive Glass Putty and Bioactive glass putty regenerative techniques for intrabony defects
      in humans.

      Material and methods: Ten pairs of intrabony defects were surgically treated with PRF and
      Bioactive glass putty (Test group) on one side or bioactive glass putty (Control group) on
      other side. The primary outcomes of the study included changes in probing depth, attachment
      level and bone fill of Osseous defect. The clinical parameters were recorded at baseline, 3,
      6, and 9 months. Radiographic assessment was done using standardized intra oral periapical
      radiographs. Comparisions were made within each group between baseline, 3 months, 6 months
      and 9 months using the ANOVA test followed by Bonferroni test.
INTRODUCTION

      Periodontitis is an infectious disease that causes destruction of the attachment
      apparatus.[1].The mainstay aim of periodontal treatment is the regeneration of the lost
      attachment apparatus of the teeth. Variety of treatment modalities are available for
      periodontal regenerative therapy including bone grafts, bone substitutes, Guided Tissue
      Regeneration, growth factors, application of tissue engineering or the combination of two or
      more of the above listed approaches. [2] Alloplasts, may be an effective alternative to
      allograft and xenografts as there is no risk of disease transmission and the supply is
      unlimited.[3] The Bioactive glass promotes osteogenesis by adsorption and concentrations of
      protein utilized by osteoblast to form a mineralized extracellular matrix. [4] The advantage
      of the putty form of bioactive glass is the glycerine and polyethylene glycol which makes the
      glass particle coherent and thus enhancing handling characteristics and minimal migration of
      graft particles from the defect site. [5] Histological evaluation of material has shown that
      the particulate tends to retard the down growth of epithelial tissue. [6,7,8,9] Growth
      factors play a pivotal role in periodontal regeneration. Platelet Rich Fibrin is believed to
      release polypeptide growth factors, such as transforming growth factors-ß, platelet derived
      growth factors, vascular endothelial growth factors and matrix glycoproteins (such as
      thrombospondin -1) into the surgical wound in a sustained fashion for at least 7 days as
      shown in vitro. [10] Thus, given the unique graft with osteoconductive, osteoinductive and
      osteostimulative properties and properties of autologous PRF, application of combination
      approach was attempted for the assessment of their additional benefits to the healing
      mechanisms and periodontal regeneration in intrabony defects.

      Materials and methods Patient Selection This randomized control trial was carried out in the
      Department of Periodontics and Oral Implantology, Santosh Dental College and Hospital,
      Santosh University, Ghaziabad. Ten patients suffering chronic localized periodontitis aged
      between 20 -50 years (7 males and 3 females) with 10 pairs of contalateral intraosseous
      defects (n=20) comprised the study population. A total of 20 bone defects (10 pairs) were
      decided by the statisticion to be of statistical strength. Convenient sampling design was
      used for the enrolment of study patients. Ethical approval was taken from the institutional
      ethical committee The patients were explained in detail about the procedure and a written
      informed consent was taken. The intrabony defects were diagnosed clinically with moderate to
      deep periodontal pockets > or = 5mm and with clinical and radiographic evidence of
      vertical/angular osseous defects. [3] Patients with systemic diseases, on anticoagulants,
      those with habit of smoking and alcohol, with known history of allergy to graft material and
      who have undergone periodontal surgical treatment for chronic periodontitis within twelve
      months for the same defects were excluded from the study.

      PRESURGICAL THERAPY Patients underwent phase I therapy. The selected defects were evaluated
      after 2 weeks, and persistent pockets > or = 5mm and patients with clinical radiographic
      evidence of angular osseous defects were scheduled for surgery.

      Clinical Parameters :

      Oral hygiene status was recorded using the gingival index of Loe & Sillness,[11];

      with score 0 indicating absence of inflammation and score 3 indicating severe

      inflammation and plaque index of Silness & Loe. [12]

      Probing pocket depth and Clinical attachment level were recorded at baseline on the

      day of surgery, 3, 6 and 9 months intervals using UNC-15 probe and customized

      acrylic occlusal stents grooved in the area of defect to provide reproducible insertion

      axis-

      The following measurements were recorded with customized

      acrylic stent:

        -  Fixed reference point (FRP) to the base of pocket (BP)

        -  Fixed reference point (FRP) to the cemento-enamel junction (CEJ)

        -  Fixed reference point (FRP) to the gingival margin (GM)

      PPD and CAL were calculated from these probing measurements as:

        -  PPD = (FRP to BP) - (FRP to GM)

        -  CAL= (FRP to BP) - (FRP to CEJ)

      Radiographic measurements: Standardized intra-oral periapical radiographs of the defects were
      taken using a paralleling technique.[13]

      Amount of defect fill: Defects were measured from the fixed reference point (distance between
      the cemento-enamel junction to the radiographic base of the bone defect ) with the help of
      1.1 mm grid and the following radiographic features were recorded on the day of surgery, 3, 6
      and 9 months intervals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Intrabony defect fill
time frame: baseline to 9 months
description: change in intrabony defect fill from baseline to 9 months
measure: Probing depth
time frame: baseline to 9 months
description: change in probing depth from baseline to 9 months
measure: Clinical attachment level
time frame: baseline to 9 months
description: change in Clinical attachment level from baseline to 9 months
measure: Gingival Index
time frame: baseline to 9 months
description: change in Gingival Index from baseline to 9 months
arm group label: Platelet rich Fibrin
arm group type: Experimental
description: The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site secured with vicryl sutures.
arm group label: Bioactive glass
arm group type: Active Comparator
description: The intrabony defects were treated with Full thickness mucoperiosteal flap was raised and thorough open flap debridement done under local anesthesia and The control site were packed with the graft alone
intervention type: Drug
intervention name: Platelet rich fibrin
description: In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site
arm group label: Platelet rich Fibrin
other name: PRF
intervention type: Drug
intervention name: Bioactive Glass
description: The control site were packed with the bioactive glass graft alone
arm group label: Bioactive glass
other name: Novabone
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
citation: Hall EE, Meffert RM, Hermann JS, Mellonig JT, Cochran DL. Comparison of bioactive glass to demineralized freeze-dried bone allograft in the treatment of intrabony defects around implants in the canine mandible. J Periodontol. 1999 May;70(5):526-35. doi: 10.1902/jop.1999.70.5.526.
PMID: 10368057
citation: Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
PMID: 19089687
responsible party type: Principal Investigator
investigator affiliation: Dr. D. Y. Patil Dental College & Hospital
investigator full name: Santosh Martande
investigator title: Assistant Professor
mesh term: Bone Resorption
mesh term: Periodontal Diseases