<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/NCT03792113</url>
  </required_header>
  <id_info>
    <org_study_id>nehafibringlue</org_study_id>
    <nct_id>NCT03792113</nct_id>
  </id_info>
  <brief_title>AUTOLOGOUS FIBRIN GLUE VERSES 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE</brief_title>
  <official_title>EVALUATION AND COMPARISON OF THE EFFICACY OF AUTOLOGOUS FIBRIN GLUE WITH 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE AND WOUND HEALING - A SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLE Society's Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KLE Society's Institute of Dental Sciences</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 study is a split mouth study but the interventions for the two different arms will be&#xD;
      spaced by a fixed duration in time. Verbal and written consent will be obtained from the&#xD;
      patients fulfilling the inclusion and exclusion criteria after briefing them about the&#xD;
      procedure. Following phase-1 periodontal therapy, randomisation for the test and control&#xD;
      quadrants will be done. Surgical debridement will be done first for the control side to avoid&#xD;
      the carry-across effect of fibrin glue. Control and test procedures will be performed with a&#xD;
      wash out period of 15days.&#xD;
&#xD;
      Preparation of Autologous fibrin glue :&#xD;
&#xD;
        -  10 ml of blood will be withdrawn from healthy adult human donor by venous puncture into&#xD;
           sodium citrate vials and will be centrifuged for 30 min at 1200 g to obtain&#xD;
           platelet-poor plasma (PPP).&#xD;
&#xD;
        -  To the solution, fibrinogen and protamine sulphate will be added and will be centrifuged&#xD;
           at 1000 g for 5 min to sediment the precipitate and fibrin glue will be procured.&#xD;
&#xD;
      Prior to commencement of periodontal flap surgery GCF collection will be done. Following&#xD;
      anaesthesia and elevation of full thickness muco periosteal flap, thorough debridement and&#xD;
      root planning of the exposed root surfaces will be done. On the control site, the periodontal&#xD;
      flap will be approximated using 4-0 black silk suture. Patients will be instructed to rinse&#xD;
      twice daily with 0.12% chlorhexidine and recalled after 7 days for suture removal and&#xD;
      post-surgical GCF collection from the control side. After a wash out period of 15 days&#xD;
      presurgical GCF sampling along with the surgical procedure will be performed on the test&#xD;
      side. The periodontal flap will be approximated on the test site using autologous fibrin glue&#xD;
      on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned&#xD;
      back on to the root surface. Thereafter, the tissues will be kept in position with a gentle&#xD;
      pressure using a wet gauze for 30 - 60 seconds. Persistence of bleeding, stability of tissues&#xD;
      5 minutes after repositioning will be recorded and the amount of fibrin sealant used in the&#xD;
      procedure will be determined.Patients will be then recalled after 7 days for evaluation and&#xD;
      post-surgical GCF collection from the test site. Clinical parameters will be assessed at 7,&#xD;
      14, 21 and 28 days.&#xD;
&#xD;
      Collection of GCF :&#xD;
&#xD;
      GCF will be collected immediately prior to surgery and on seventh day following surgery from&#xD;
      both test and control sites for wound healing assessment. Samples of GCF will be collected&#xD;
      from four sites from the surgical site following isolation. Colour - coded, 1-5 microlitre&#xD;
      calibrated volumetric micro capillary pipettes will be kept extra-crevicularly for not more&#xD;
      than five minutes or until 1 microlitre is collected. The fluid will be immediately&#xD;
      transferred to a plastic vial and frozen at -20 degree Celsius for further analysis. Pipettes&#xD;
      in sites which do not express any fluid or those contaminated with blood/saliva will be&#xD;
      discarded.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The data gathered from the study will be subjected to appropriate statistical analysis. The&#xD;
      statistical analysis will be done using:&#xD;
&#xD;
        1. Mann-Whitney test&#xD;
&#xD;
        2. Wilcoxon signed rank test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 2/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>
    <intervention_model_description>Patients diagnosed with periodontitis, in the age group of 18 to 60 years with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The study design follows a double blinded design where the investigator and the outcome assessor are unaware of the intervention to the subject</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cytokine parameter</measure>
    <time_frame>Change from baseline to 7days</time_frame>
    <description>Interleukin 1-β will be assessed in GCF using a commercially available Enzyme-linked immunosorbent assay kit (ELISA), specific for human IL-1 β</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral Hygiene Index</measure>
    <time_frame>Changes from baseline to 7day, 14day, 21day, 28day</time_frame>
    <description>by John C Greene &amp; Jack Vermilion in 1964 OHI = DI + CI INTERPRETATION Good 0.0-1.2 Fair 1.3-3.0 Poor 3.1-6.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Wound Healing Index</measure>
    <time_frame>Changes from baseline to 7th day, 14th day, 21st day and 28th day</time_frame>
    <description>Index given by Watchel et al in 2005&#xD;
SCORING CRITERIA:&#xD;
DEGREE 1-Complete flap closure No fibrin line in the interproximal area DEGREE 2- Complete flap closure Fine fibrin line in the interproximal area DEGREE 3- Complete flap closure Fibrin clot in the interproximal area DEGREE 4- Incomplete flap closure Partial necrosis of interproximal tissue DEGREE 5- Incomplete flap closure Complete necrosis of interproximal tissue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Index</measure>
    <time_frame>Changes from baseline to 7th day, 14th day, 21st day and 28th day</time_frame>
    <description>Index given by Loe and Silness in 1963 Scoring criteria 0 = Normal gingiva&#xD;
= Mild inflammation, slight change in color, slight edema, no bleeding on probing.&#xD;
= Moderate inflammation, redness, edema, and glazing, bleeding on probing.&#xD;
= Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding.&#xD;
Score 0.1-1.0-Mild gingivitis 1.1-2-Moderate gingivitis 2.1-3.0 Severe gingivitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS score</measure>
    <time_frame>Changes from baseline to 7th day, 14th day, 21st day and 28th day</time_frame>
    <description>Index given by Freyd in 1923 Scale -1-10 Score Scale: 0-10 Score 0-No pain 1-3: Mild 4-6: Moderate 7-9: severe 10-worst</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Autologous fibrin glue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4-0 silk suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The periodontal flap will be approximated using 4-0 black silk suture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal Flap Surgery</intervention_name>
    <description>Periodontal access flap surgery will be performed in both test site followed by control site in each subject</description>
    <arm_group_label>4-0 silk suture</arm_group_label>
    <arm_group_label>Autologous fibrin glue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autologous fibrin glue</intervention_name>
    <description>Autologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery</description>
    <arm_group_label>Autologous fibrin glue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>4-0 silk suture</intervention_name>
    <description>Conventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery</description>
    <arm_group_label>4-0 silk suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with periodontitis, with good systemic health and presence of a&#xD;
             minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment&#xD;
             level (CAL) of ≥5mm (stage 3 periodontitis as described by the 2017 World Workshop on&#xD;
             the Classification of Periodontal and Peri-Implant Diseases and Condition and&#xD;
             published by the American Academy of Periodontology) in at least two quadrants will be&#xD;
             selected.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone periodontal therapy during the previous 6 months, or&#xD;
             exhibit poor plaque control after phase I therapy.&#xD;
&#xD;
          -  History of any systemic disease such as diabetes mellitus, hypertension,osteoporosis,&#xD;
             unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or&#xD;
             other antimicrobial therapy.&#xD;
&#xD;
          -  Patients on drugs like aspirin, blood thinners and anticoagulant therapy&#xD;
&#xD;
          -  Patients with history of allergy&#xD;
&#xD;
          -  Current or former smokers.&#xD;
&#xD;
          -  Mobility of selected teeth.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Neha Pradhan, BDS, Post graduate student</last_name>
    <phone>9620508212</phone>
    <phone_ext>+91</phone_ext>
    <email>pradhanneha92@yahoo.in</email>
  </overall_contact>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KLE Society's Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>Dr Laveena Singhal</investigator_full_name>
    <investigator_title>Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>For the purpose of confidentiality as will be promised to the participants while signing the informed consent , all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers</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/NCT03792113
org study id: nehafibringlue
nct id: NCT03792113
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is a split mouth study but the interventions for the two different arms will be
      spaced by a fixed duration in time. Verbal and written consent will be obtained from the
      patients fulfilling the inclusion and exclusion criteria after briefing them about the
      procedure. Following phase-1 periodontal therapy, randomisation for the test and control
      quadrants will be done. Surgical debridement will be done first for the control side to avoid
      the carry-across effect of fibrin glue. Control and test procedures will be performed with a
      wash out period of 15days.

      Preparation of Autologous fibrin glue :

        -  10 ml of blood will be withdrawn from healthy adult human donor by venous puncture into
           sodium citrate vials and will be centrifuged for 30 min at 1200 g to obtain
           platelet-poor plasma (PPP).

        -  To the solution, fibrinogen and protamine sulphate will be added and will be centrifuged
           at 1000 g for 5 min to sediment the precipitate and fibrin glue will be procured.

      Prior to commencement of periodontal flap surgery GCF collection will be done. Following
      anaesthesia and elevation of full thickness muco periosteal flap, thorough debridement and
      root planning of the exposed root surfaces will be done. On the control site, the periodontal
      flap will be approximated using 4-0 black silk suture. Patients will be instructed to rinse
      twice daily with 0.12% chlorhexidine and recalled after 7 days for suture removal and
      post-surgical GCF collection from the control side. After a wash out period of 15 days
      presurgical GCF sampling along with the surgical procedure will be performed on the test
      side. The periodontal flap will be approximated on the test site using autologous fibrin glue
      on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned
      back on to the root surface. Thereafter, the tissues will be kept in position with a gentle
      pressure using a wet gauze for 30 - 60 seconds. Persistence of bleeding, stability of tissues
      5 minutes after repositioning will be recorded and the amount of fibrin sealant used in the
      procedure will be determined.Patients will be then recalled after 7 days for evaluation and
      post-surgical GCF collection from the test site. Clinical parameters will be assessed at 7,
      14, 21 and 28 days.

      Collection of GCF :

      GCF will be collected immediately prior to surgery and on seventh day following surgery from
      both test and control sites for wound healing assessment. Samples of GCF will be collected
      from four sites from the surgical site following isolation. Colour - coded, 1-5 microlitre
      calibrated volumetric micro capillary pipettes will be kept extra-crevicularly for not more
      than five minutes or until 1 microlitre is collected. The fluid will be immediately
      transferred to a plastic vial and frozen at -20 degree Celsius for further analysis. Pipettes
      in sites which do not express any fluid or those contaminated with blood/saliva will be
      discarded.

      Statistical analysis:

      The data gathered from the study will be subjected to appropriate statistical analysis. The
      statistical analysis will be done using:

        1. Mann-Whitney test

        2. Wilcoxon signed rank test.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients diagnosed with periodontitis, in the age group of 18 to 60 years with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: The study design follows a double blinded design where the investigator and the outcome assessor are unaware of the intervention to the subject
measure: Cytokine parameter
time frame: Change from baseline to 7days
description: Interleukin 1-β will be assessed in GCF using a commercially available Enzyme-linked immunosorbent assay kit (ELISA), specific for human IL-1 β
measure: Oral Hygiene Index
time frame: Changes from baseline to 7day, 14day, 21day, 28day
description: by John C Greene & Jack Vermilion in 1964 OHI = DI + CI INTERPRETATION Good 0.0-1.2 Fair 1.3-3.0 Poor 3.1-6.0
measure: Early Wound Healing Index
time frame: Changes from baseline to 7th day, 14th day, 21st day and 28th day
description: Index given by Watchel et al in 2005
SCORING CRITERIA:
DEGREE 1-Complete flap closure No fibrin line in the interproximal area DEGREE 2- Complete flap closure Fine fibrin line in the interproximal area DEGREE 3- Complete flap closure Fibrin clot in the interproximal area DEGREE 4- Incomplete flap closure Partial necrosis of interproximal tissue DEGREE 5- Incomplete flap closure Complete necrosis of interproximal tissue
measure: Gingival Index
time frame: Changes from baseline to 7th day, 14th day, 21st day and 28th day
description: Index given by Loe and Silness in 1963 Scoring criteria 0 = Normal gingiva
= Mild inflammation, slight change in color, slight edema, no bleeding on probing.
= Moderate inflammation, redness, edema, and glazing, bleeding on probing.
= Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding.
Score 0.1-1.0-Mild gingivitis 1.1-2-Moderate gingivitis 2.1-3.0 Severe gingivitis
measure: VAS score
time frame: Changes from baseline to 7th day, 14th day, 21st day and 28th day
description: Index given by Freyd in 1923 Scale -1-10 Score Scale: 0-10 Score 0-No pain 1-3: Mild 4-6: Moderate 7-9: severe 10-worst
arm group label: Autologous fibrin glue
arm group type: Experimental
description: The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds.
arm group label: 4-0 silk suture
arm group type: Active Comparator
description: The periodontal flap will be approximated using 4-0 black silk suture.
intervention type: Procedure
intervention name: Periodontal Flap Surgery
description: Periodontal access flap surgery will be performed in both test site followed by control site in each subject
arm group label: 4-0 silk suture
arm group label: Autologous fibrin glue
intervention type: Other
intervention name: Autologous fibrin glue
description: Autologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery
arm group label: Autologous fibrin glue
intervention type: Other
intervention name: 4-0 silk suture
description: Conventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery
arm group label: 4-0 silk suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Neha Pradhan, BDS, Post graduate student
phone: 9620508212
phone ext: +91
email: pradhanneha92@yahoo.in
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Dr Laveena Singhal
investigator title: Post graduate student, Principal investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore
mesh term: Periodontitis
mesh term: Fibrin Tissue Adhesive
sharing ipd: No
ipd description: For the purpose of confidentiality as will be promised to the participants while signing the informed consent , all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers