<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/NCT03756493</url>
  </required_header>
  <id_info>
    <org_study_id>11042017</org_study_id>
    <nct_id>NCT03756493</nct_id>
  </id_info>
  <brief_title>Added Benefit of L-PRF to Autogenous Bone Graft in the Treatment of Mandibular Degree II Furcation Defects</brief_title>
  <official_title>The Added Benefit of L-PRF to Autogenous Bone Graft in the Treatment of Degree II Furcation Involvements in Mandibular Molars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>G. d'Annunzio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>G. d'Annunzio University</source>
  <oversight_info>
    <has_dmc>No</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>
      Different therapeutic approaches have been proposed for the treatment of furcation defects&#xD;
      and the regeneration of periodontium within the furcation area is considered one of the most&#xD;
      challenging aspect of surgical periodontal therapy.&#xD;
&#xD;
      Periodontal regeneration is a highly predictable therapeutic option for the treatment of&#xD;
      different furcation defects, particularly class II furcation involvements in the lower&#xD;
      molars.&#xD;
&#xD;
      In particular, the application of a combined therapeutic approach (i.e., barrier, bone&#xD;
      re-placement graft with or without biological agents) seems to offer better results as&#xD;
      compared with monotherapeutic treatments.&#xD;
&#xD;
      Several studies have demonstrated that platelet concentrates, such as platelet-rich plasma&#xD;
      (PRP), platelet-derived growth factor (PDGF) and, more recently, leukocyte and platelet-rich&#xD;
      fibrin (L-PRF) can represent new therapeutic options for bone regeneration procedures by&#xD;
      increasing the healing potential of natural blood clot in the surgical site.&#xD;
&#xD;
      Leukocyte and Platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate,&#xD;
      developed by Choukroun et al. It is prepared without the addition of any anticoagulants and&#xD;
      consists of a slowly polymerized complex fibrin network which incorporates leukocytes, glycan&#xD;
      chains, structural glycoproteins and an high concentration of growth factors such as&#xD;
      transforming growth factor β (TGF-B), platelet-derived growth factor (PDGF), vascular&#xD;
      endothelial growth factor (VEGF). The three-dimensional architecture and the specific&#xD;
      biochemical properties, which facilitate the wound healing processes, have led to a&#xD;
      widespread use of this biomaterial in plastic surgery, maxillofacial surgery, oral and&#xD;
      periodontal surgery.&#xD;
&#xD;
      A large clinical and histological evidence supports the concept that autogenous bone grafts&#xD;
      (ABG) are highly effective regenerative materials in the treatment of intrabony defects.&#xD;
      Moreover, with respect to the treatment of furcation defects, outcome data from a number of&#xD;
      studies generally indicate positive clinical benefits with the use of bone grafts in the&#xD;
      treatment of Class II furcations.&#xD;
&#xD;
      Therefore, on the basis of such considerations, the aim of this study was to evaluate the&#xD;
      effectiveness of a combined regenerative treatment by L- PRF and ABG in the treatment of&#xD;
      mandibular molars degree II furcation defects and to compare the outcomes of such a treatment&#xD;
      with those from (OFD)+ABG and OFD alone treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental Design. This randomized, comparative and clinical trial will be designed to&#xD;
      evaluate the clinical and radiographic outcomes 6 months after three treatment modalities of&#xD;
      mandibular degree II furcation defects.&#xD;
&#xD;
      The patients study will exhibit buccal or lingual mandibular degree II furcation defects; all&#xD;
      experimental sites will be accessed with a SPPF procedure. L- PRF and autogenous bone graft&#xD;
      (ABG) will be applied to the debrided defects in the OFD+ABG+L-PRF group; the OFD+ABG group&#xD;
      will receive only ABG and the OFD group will be treated with Open Flap Debridement (OFD)&#xD;
      alone.&#xD;
&#xD;
      Study Population. At least fifty-four patients, aged 18 to 70 years old, affected by&#xD;
      moderate-to-severe chronic periodontitis, will be selected for this study and treated at the&#xD;
      Operating Unit of Periodontology and Oral Hygiene of the Department of Medical, Oral and&#xD;
      Biotechnological Sciences, &quot;G. D'Annunzio&quot; Chieti-Pescara University, Italy. Each patient&#xD;
      will participate in the study with a single experimental site.&#xD;
&#xD;
      The participants will receive verbal and written information and will sign a consent form&#xD;
      approved by the Ethical Committee of the G. D'Annunzio University of Chieti medical faculty.&#xD;
      The study protocol is in accordance with the Declaration of Helsinki of 1975, as revised in&#xD;
      2013.&#xD;
&#xD;
      Each defect will be assigned a defect number and will be randomly allocated to one of the&#xD;
      three treatment regimens. Assignment will be performed by a custom made computer-generated&#xD;
      table. To conceal allocation, opaque envelops will be assigned to the specific experimental&#xD;
      site and will be opened during surgery.&#xD;
&#xD;
      Four months before the surgical treatment, all 54 patients will undergo non-surgical&#xD;
      periodontal treatment consisting of supragingival and subgingival scaling and root planing&#xD;
      (SRP) by ultrasonic instruments and hand curets and motivational instructions on oral home&#xD;
      care.&#xD;
&#xD;
      Complete oral and periodontal examinations will be performed for each patient before and 4&#xD;
      months after the non-surgical treatment. These will include full mouth plaque score (FMPS),&#xD;
      full mouth bleeding score (FMBS), probing depth (PD), vertical clinical attachment level&#xD;
      (VCAL), horizontal clinical attachment level (HCAL), and gingival recession (GR) for six&#xD;
      sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/ palatal,&#xD;
      mid-lingual/palatal, and disto-lingual/palatal sites). The measurements will be recorded&#xD;
      using a University of North Carolina (UNC-15, HuFriedy, Chicago, Illinois, USA) periodontal&#xD;
      probe.&#xD;
&#xD;
      Clinical measurements at mid-buccal or mid-lingual experimental sites will be taken&#xD;
      immediately before surgical treatment (baseline) and 6 months after treatment, by the same&#xD;
      experienced examiner (MP), who will be masked to the treatment. The primary outcome of the&#xD;
      study will be HCAL gain at 6 months.&#xD;
&#xD;
      Radiographic Measurements. Preoperative and 6 months postoperative standardized radiographs&#xD;
      will be taken by the paralleling technique using an individual film-holder device consisting&#xD;
      of a bite block rigidly connected to an acrylic dental splint to achieve identical film&#xD;
      placement at each evaluation.&#xD;
&#xD;
      The radiographs will be digitized using an image processing device, after choosing the&#xD;
      standard scan settings (600 dots per inch and 256 levels of gray).&#xD;
&#xD;
      Measurements related to vertical bone level (VBL) will be performed using a dedicated&#xD;
      software and calculating the distance between the furcation fornix and the bottom of the&#xD;
      defect.&#xD;
&#xD;
      Before surgery, from each patient of all groups, to avoid unblinding, 30 ml of blood was&#xD;
      collected in three 10-ml sterile tubes without anticoagulant, and it was quickly&#xD;
      centrifuged‖‖ at 3,000 revolutions/minute for 10 minutes.The fibrin clot (L-PRF) was&#xD;
      collected and squeezed in the L-PRF Box to form three membranes.&#xD;
&#xD;
      Surgical Technique. All the surgeries will be performed by the same experienced clinician. In&#xD;
      all groups, after local anaesthesia, mucoperiosteal SPPFs will be raised. Mesial and distal&#xD;
      vertical releasing incisions will be performed to allow more visibility and defects&#xD;
      accessibility. After flap elevation, flap mobility will be tested to ensure that primary&#xD;
      closure of the wound could be achieved through tension-free suturing. The granulation tissue&#xD;
      adherent to the alveolar bone will be removed to provide full access and visibility to the&#xD;
      root and bone surfaces. SRP will be performed. ABG material will be collected using bone&#xD;
      scrapers in OFD+ABG+L-PRF group and OFD+ABG group.&#xD;
&#xD;
      In the OFD+ABG+L-PRF group , one L-PRF membrane cutted into small pieces and mixed with ABG&#xD;
      will be placed in the furcation defect. The other PRF membranes in each patient will be&#xD;
      placed over the grafted defect and will be sutured with an absorbable suture. The OFD+ABG&#xD;
      group defects will be grafted only with ABG and will be not covered by a L-PRF membrane. The&#xD;
      OFD group defect will be treated only with open flap debridement. Finally the flap will be&#xD;
      repositioned and horizontal mattress and interrupted sutures will be carried out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">May 4, 2020</completion_date>
  <primary_completion_date type="Actual">May 4, 2020</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Horizontal Clinical Attachment Gain</measure>
    <time_frame>6 months</time_frame>
    <description>The periodontal probe was inserted into the furcation area, perpendicular to a horizontal one which was placed on the buccal or lingual aspect of the involved tooth.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vertical Bone Level</measure>
    <time_frame>6 months</time_frame>
    <description>Radiographic distance between the fornix of furcation and the bottom of the defect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertical Clinical Attachment Gain</measure>
    <time_frame>6 months</time_frame>
    <description>Change of the distance between the cementum-enamel junction and the depth of the probable site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pocket Probing Depth</measure>
    <time_frame>6 months</time_frame>
    <description>Change of the distance between the gingival margin and the depth of the probable site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival recession</measure>
    <time_frame>6 months</time_frame>
    <description>Change of the distance between the cementum-enamel junction and the gingival margin of the probable site.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Periodontal Attachment Loss</condition>
  <condition>Periodontal Bone Loss</condition>
  <arm_group>
    <arm_group_label>OFD+ABG+L-PRF treated patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Periodontal surgery with Leukocyte and Platelet Rich Fibrin (L-PRF) is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous bone graft mixed with cutted L-PRF will be applied to the furcation defects; then, a L-PRF membrane is positioned above the filling material. Finally the flap will be coronally positionated and sutured by interrupted sutures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OFD+ABG treated patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Periodontal surgery with Autogenous Bone Graft (ABG) is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. ABG will be applied to the furcation defects. Finally the flap will be coronally positioned and sutured by interrupted sutures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OFD treated patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Periodontal surgery with Open Flap Debridement is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. No grafts will be applied to the furcation defects. Finally the flap will be coronally positioned and sutured by interrupted sutures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal Surgery with OFD+ABG+L-PRF</intervention_name>
    <description>Patients will be treated by periodontal surgical flaps with the addition of L-PRF+ Autogenous Bone Graft filling material.</description>
    <arm_group_label>OFD+ABG+L-PRF treated patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal Surgery with OFD+ABG</intervention_name>
    <description>Patients will be treated by periodontal surgical flaps with the addition of Autogenous Bone Graft filling material.</description>
    <arm_group_label>OFD+ABG treated patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Periodontal Surgery OFD</intervention_name>
    <description>Patients will be treated by Open Flap Debridement without use of filling material.</description>
    <arm_group_label>OFD treated patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a Full-Mouth Plaque Score (FMPS) and a Full-Mouth Bleeding Score (FMBS) &lt; 20% at the&#xD;
             time of surgery;&#xD;
&#xD;
          -  to have at least 20 teeth;&#xD;
&#xD;
          -  at least 1 mandibular molar with buccal or lingual degree II furcation defects, with&#xD;
             no mobility and with horizontal CAL (HCAL) &gt; 3 mm and vertical probing depth in the&#xD;
             central-vestibular or central-lingual site &gt;= 5 mm after non surgical treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases;&#xD;
&#xD;
          -  medications affecting periodontal status during the previous 6 months;&#xD;
&#xD;
          -  pregnant or lactating;&#xD;
&#xD;
          -  smokers;&#xD;
&#xD;
          -  periodontal therapy in the 2 previous years;&#xD;
&#xD;
          -  periapical endodontic lesions;&#xD;
&#xD;
          -  dental mobility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>G. d'Annunzio University</name>
      <address>
        <city>Chieti</city>
        <state>CH</state>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>G. d'Annunzio University</investigator_affiliation>
    <investigator_full_name>Michele Paolantonio</investigator_full_name>
    <investigator_title>full time professor</investigator_title>
  </responsible_party>
  <keyword>Platlet rich fibrin</keyword>
  <keyword>Bone graft</keyword>
  <keyword>Furcation defects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
    <mesh_term>Furcation Defects</mesh_term>
    <mesh_term>Periodontal Attachment Loss</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/NCT03756493
org study id: 11042017
nct id: NCT03756493
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Different therapeutic approaches have been proposed for the treatment of furcation defects
      and the regeneration of periodontium within the furcation area is considered one of the most
      challenging aspect of surgical periodontal therapy.

      Periodontal regeneration is a highly predictable therapeutic option for the treatment of
      different furcation defects, particularly class II furcation involvements in the lower
      molars.

      In particular, the application of a combined therapeutic approach (i.e., barrier, bone
      re-placement graft with or without biological agents) seems to offer better results as
      compared with monotherapeutic treatments.

      Several studies have demonstrated that platelet concentrates, such as platelet-rich plasma
      (PRP), platelet-derived growth factor (PDGF) and, more recently, leukocyte and platelet-rich
      fibrin (L-PRF) can represent new therapeutic options for bone regeneration procedures by
      increasing the healing potential of natural blood clot in the surgical site.

      Leukocyte and Platelet-rich fibrin (L-PRF) is a second-generation platelet concentrate,
      developed by Choukroun et al. It is prepared without the addition of any anticoagulants and
      consists of a slowly polymerized complex fibrin network which incorporates leukocytes, glycan
      chains, structural glycoproteins and an high concentration of growth factors such as
      transforming growth factor β (TGF-B), platelet-derived growth factor (PDGF), vascular
      endothelial growth factor (VEGF). The three-dimensional architecture and the specific
      biochemical properties, which facilitate the wound healing processes, have led to a
      widespread use of this biomaterial in plastic surgery, maxillofacial surgery, oral and
      periodontal surgery.

      A large clinical and histological evidence supports the concept that autogenous bone grafts
      (ABG) are highly effective regenerative materials in the treatment of intrabony defects.
      Moreover, with respect to the treatment of furcation defects, outcome data from a number of
      studies generally indicate positive clinical benefits with the use of bone grafts in the
      treatment of Class II furcations.

      Therefore, on the basis of such considerations, the aim of this study was to evaluate the
      effectiveness of a combined regenerative treatment by L- PRF and ABG in the treatment of
      mandibular molars degree II furcation defects and to compare the outcomes of such a treatment
      with those from (OFD)+ABG and OFD alone treatments.
Experimental Design. This randomized, comparative and clinical trial will be designed to
      evaluate the clinical and radiographic outcomes 6 months after three treatment modalities of
      mandibular degree II furcation defects.

      The patients study will exhibit buccal or lingual mandibular degree II furcation defects; all
      experimental sites will be accessed with a SPPF procedure. L- PRF and autogenous bone graft
      (ABG) will be applied to the debrided defects in the OFD+ABG+L-PRF group; the OFD+ABG group
      will receive only ABG and the OFD group will be treated with Open Flap Debridement (OFD)
      alone.

      Study Population. At least fifty-four patients, aged 18 to 70 years old, affected by
      moderate-to-severe chronic periodontitis, will be selected for this study and treated at the
      Operating Unit of Periodontology and Oral Hygiene of the Department of Medical, Oral and
      Biotechnological Sciences, "G. D'Annunzio" Chieti-Pescara University, Italy. Each patient
      will participate in the study with a single experimental site.

      The participants will receive verbal and written information and will sign a consent form
      approved by the Ethical Committee of the G. D'Annunzio University of Chieti medical faculty.
      The study protocol is in accordance with the Declaration of Helsinki of 1975, as revised in
      2013.

      Each defect will be assigned a defect number and will be randomly allocated to one of the
      three treatment regimens. Assignment will be performed by a custom made computer-generated
      table. To conceal allocation, opaque envelops will be assigned to the specific experimental
      site and will be opened during surgery.

      Four months before the surgical treatment, all 54 patients will undergo non-surgical
      periodontal treatment consisting of supragingival and subgingival scaling and root planing
      (SRP) by ultrasonic instruments and hand curets and motivational instructions on oral home
      care.

      Complete oral and periodontal examinations will be performed for each patient before and 4
      months after the non-surgical treatment. These will include full mouth plaque score (FMPS),
      full mouth bleeding score (FMBS), probing depth (PD), vertical clinical attachment level
      (VCAL), horizontal clinical attachment level (HCAL), and gingival recession (GR) for six
      sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/ palatal,
      mid-lingual/palatal, and disto-lingual/palatal sites). The measurements will be recorded
      using a University of North Carolina (UNC-15, HuFriedy, Chicago, Illinois, USA) periodontal
      probe.

      Clinical measurements at mid-buccal or mid-lingual experimental sites will be taken
      immediately before surgical treatment (baseline) and 6 months after treatment, by the same
      experienced examiner (MP), who will be masked to the treatment. The primary outcome of the
      study will be HCAL gain at 6 months.

      Radiographic Measurements. Preoperative and 6 months postoperative standardized radiographs
      will be taken by the paralleling technique using an individual film-holder device consisting
      of a bite block rigidly connected to an acrylic dental splint to achieve identical film
      placement at each evaluation.

      The radiographs will be digitized using an image processing device, after choosing the
      standard scan settings (600 dots per inch and 256 levels of gray).

      Measurements related to vertical bone level (VBL) will be performed using a dedicated
      software and calculating the distance between the furcation fornix and the bottom of the
      defect.

      Before surgery, from each patient of all groups, to avoid unblinding, 30 ml of blood was
      collected in three 10-ml sterile tubes without anticoagulant, and it was quickly
      centrifuged‖‖ at 3,000 revolutions/minute for 10 minutes.The fibrin clot (L-PRF) was
      collected and squeezed in the L-PRF Box to form three membranes.

      Surgical Technique. All the surgeries will be performed by the same experienced clinician. In
      all groups, after local anaesthesia, mucoperiosteal SPPFs will be raised. Mesial and distal
      vertical releasing incisions will be performed to allow more visibility and defects
      accessibility. After flap elevation, flap mobility will be tested to ensure that primary
      closure of the wound could be achieved through tension-free suturing. The granulation tissue
      adherent to the alveolar bone will be removed to provide full access and visibility to the
      root and bone surfaces. SRP will be performed. ABG material will be collected using bone
      scrapers in OFD+ABG+L-PRF group and OFD+ABG group.

      In the OFD+ABG+L-PRF group , one L-PRF membrane cutted into small pieces and mixed with ABG
      will be placed in the furcation defect. The other PRF membranes in each patient will be
      placed over the grafted defect and will be sutured with an absorbable suture. The OFD+ABG
      group defects will be grafted only with ABG and will be not covered by a L-PRF membrane. The
      OFD group defect will be treated only with open flap debridement. Finally the flap will be
      repositioned and horizontal mattress and interrupted sutures will be carried out.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Horizontal Clinical Attachment Gain
time frame: 6 months
description: The periodontal probe was inserted into the furcation area, perpendicular to a horizontal one which was placed on the buccal or lingual aspect of the involved tooth.
measure: Vertical Bone Level
time frame: 6 months
description: Radiographic distance between the fornix of furcation and the bottom of the defect.
measure: Vertical Clinical Attachment Gain
time frame: 6 months
description: Change of the distance between the cementum-enamel junction and the depth of the probable site.
measure: Pocket Probing Depth
time frame: 6 months
description: Change of the distance between the gingival margin and the depth of the probable site.
measure: Gingival recession
time frame: 6 months
description: Change of the distance between the cementum-enamel junction and the gingival margin of the probable site.
arm group label: OFD+ABG+L-PRF treated patients
arm group type: Experimental
description: Periodontal surgery with Leukocyte and Platelet Rich Fibrin (L-PRF) is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. Autogenous bone graft mixed with cutted L-PRF will be applied to the furcation defects; then, a L-PRF membrane is positioned above the filling material. Finally the flap will be coronally positionated and sutured by interrupted sutures.
arm group label: OFD+ABG treated patients
arm group type: Active Comparator
description: Periodontal surgery with Autogenous Bone Graft (ABG) is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. ABG will be applied to the furcation defects. Finally the flap will be coronally positioned and sutured by interrupted sutures.
arm group label: OFD treated patients
arm group type: Active Comparator
description: Periodontal surgery with Open Flap Debridement is performed, after local anaesthesia, mucoperiosteal SPPFs will be raised. No grafts will be applied to the furcation defects. Finally the flap will be coronally positioned and sutured by interrupted sutures.
intervention type: Procedure
intervention name: Periodontal Surgery with OFD+ABG+L-PRF
description: Patients will be treated by periodontal surgical flaps with the addition of L-PRF+ Autogenous Bone Graft filling material.
arm group label: OFD+ABG+L-PRF treated patients
intervention type: Procedure
intervention name: Periodontal Surgery with OFD+ABG
description: Patients will be treated by periodontal surgical flaps with the addition of Autogenous Bone Graft filling material.
arm group label: OFD+ABG treated patients
intervention type: Procedure
intervention name: Periodontal Surgery OFD
description: Patients will be treated by Open Flap Debridement without use of filling material.
arm group label: OFD treated patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: G. d'Annunzio University
investigator full name: Michele Paolantonio
investigator title: full time professor
mesh term: Alveolar Bone Loss
mesh term: Furcation Defects
mesh term: Periodontal Attachment Loss
sharing ipd: Undecided