<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/NCT04450849</url>
  </required_header>
  <id_info>
    <org_study_id>2008.1.1259.58.9</org_study_id>
    <nct_id>NCT04450849</nct_id>
  </id_info>
  <brief_title>Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects.</brief_title>
  <acronym>RPPCMABBICFD</acronym>
  <official_title>Regenerative Potential of a Collagen Membrane Associated or Not to Bovine Bone in Class II Furcation Defects - A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Periodontal disease is an infectious-inflammatory disease that accommodates the supporting&#xD;
      and supporting tissues of the teeth, with the formation of periodontal pockets, and this&#xD;
      destruction can generate anatomical defects in the region of bifurcation. Treatment of these&#xD;
      lesions is a challenge for the clinician, as this area has limited access to bacterial&#xD;
      biofilm and calculus. The surgical regenerative therapy using bone grafts and membrane may be&#xD;
      a viable option in cases of class II furcation defects. In this context, the objective of&#xD;
      this case series is to evaluate tomographically and clinically the treatment of class II&#xD;
      furcation defects using an absorbable collagen membrane (Bio-Gide® Perio) associated or not&#xD;
      with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontal disease is an infectious-inflammatory disease that accommodates the supporting&#xD;
      and supporting tissues of the teeth, with the formation of periodontal pockets, and this&#xD;
      destruction can generate anatomical defects in the region of bifurcation. Treatment of these&#xD;
      lesions is a challenge for the clinician, as this area has limited access to bacterial&#xD;
      biofilm and calculus. The surgical regenerative therapy using bone grafts and membrane may be&#xD;
      a viable option in cases of class II furcation defects. In this context, the objective of&#xD;
      this case series is to evaluate tomographically and clinically the treatment of class II&#xD;
      furcation defects using an absorbable collagen membrane (Bio-Gide® Perio) associated or not&#xD;
      with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen). In a parallel&#xD;
      design, 22 patients with mandibular class II furcation defects were recruited. Each defect&#xD;
      was randomly assigned to the control group (CG - Bio-Gide® Perio, n=11) or test group (TG -&#xD;
      Bio-Oss® Collagen + Bio-Gide® Perio, n=11). Tomographic and clinical evaluations were&#xD;
      conducted at baseline and 12 months post-surgery. Clinical measurements of clinical&#xD;
      attachment level (CAL) and probing depth (PD). Tomographical measurements of horizontal&#xD;
      defect dimension (HDD) and vertical defect dimension (VDD) were recorded. In sequence, guided&#xD;
      tissue regeneration surgeries were conducted: Then, bone defect were debrided, , the collagen&#xD;
      membranes (BioGide Perio®) were trimmed to cover the osseous defects and extended 3 mm&#xD;
      apically and laterally to the adjacent bone and sutured with absorbable suture. In the Test&#xD;
      Group, the defects were completely filled with bovine bone + porcine collagen (BioOss&#xD;
      Collagen®). The flaps were then coronally positioned until completely covering the membranes&#xD;
      and sutured. Shapiro-Wilk test was used to evaluate normality of the data, and showed a&#xD;
      normal distribution. Then, t-Test was selected for inter-group and intragroup comparisons.&#xD;
      Trans-surgical measurements were evaluated at Baseline. The other clinical and tomographic&#xD;
      parameters were evaluated at Baseline and 12 months. For all analyzes, p &lt;0.05 was&#xD;
      considered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2019</primary_completion_date>
  <phase>Phase 4</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>In a parallel design, 22 patients with mandibular class II furcation defects were recruited. Each defect was randomly assigned to the control group (CG - Bio-Gide® Perio, n=11) or test group (TG - Bio-Oss® Collagen + Bio-Gide® Perio, n=11). Tomographic and clinical evaluations were conducted at baseline and 12 months post-surgery.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>to evaluate clinical attachment level</measure>
    <time_frame>The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]</time_frame>
    <description>Change from Baseline in clinical attachment level at +360 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tomographic bone gain</measure>
    <time_frame>The Tomographic bone gain parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]</time_frame>
    <description>Change from Baseline in bone gain at +360 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Periodontal Diseases</condition>
  <condition>Bone Diseases</condition>
  <arm_group>
    <arm_group_label>collagen membrane associated to anorganic bone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Complete debridement of the osseous defects and thorough scaling and root planing using mini curettes and ultrasonic scalers were performed. The sites were randomly selected for treatment with resorbable collagen membrane (Bio-Gide® Perio) associated to anorganic bovine bone matrix + collagen (Bio-Oss® Collagen) . The membranes were trimmed to cover the lesions and extended to the adjacent bone between 2 to 3 mm apically and laterally. They were then placed in position, 2 mm below the CEJ, and fixed in position using sling 5-0 vicryl sutures. The flaps were coronally positioned until completely covering the membranes without tension and sutured with 5-0 nylon sutures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>collagen membrane alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Complete debridement of the osseous defects and thorough scaling and root planing using mini curettes and ultrasonic scalers were performed. The sites were randomly selected for treatment with resorbable collagen membrane (Bio-Gide® Perio). The membranes were trimmed to cover the lesions and extended to the adjacent bone between 2 to 3 mm apically and laterally. They were then placed in position, 2 mm below the CEJ, and fixed in position using sling 5-0 vicryl sutures. The flaps were coronally positioned until completely covering the membranes without tension and sutured with 5-0 nylon sutures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.</intervention_name>
    <description>Dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) associated with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).</description>
    <arm_group_label>collagen membrane associated to anorganic bone</arm_group_label>
    <other_name>GTR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.</intervention_name>
    <description>dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) alone.</description>
    <arm_group_label>collagen membrane alone</arm_group_label>
    <other_name>GTR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects with a diagnosis of periodontitis, Stage III and Grade A (according to the&#xD;
             2018 international classification criteria);&#xD;
&#xD;
          -  presence of one mandibular molar with class II buccal furcation defect;&#xD;
&#xD;
          -  non-smokers;&#xD;
&#xD;
          -  plaque index &lt;20%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients that presented systemic diseases;&#xD;
&#xD;
          -  patients that had taken antibiotics in the past 6 months prior to surgical procedures;&#xD;
&#xD;
          -  pregnant women or lactating mothers;&#xD;
&#xD;
          -  furcation involvement in molars with periapical disease;&#xD;
&#xD;
          -  cervical restorations or prosthesis closer than 1 mm to fornix.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>14040-904</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Sergio Luis Scombatti de Souza</investigator_full_name>
    <investigator_title>Departament of Oral &amp; Maxillofacial Surgery and Periodontology</investigator_title>
  </responsible_party>
  <keyword>periodontal diseases</keyword>
  <keyword>Periodontitis</keyword>
  <keyword>periodontal regeneration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Furcation Defects</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04450849
org study id: 2008.1.1259.58.9
nct id: NCT04450849
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Periodontal disease is an infectious-inflammatory disease that accommodates the supporting
      and supporting tissues of the teeth, with the formation of periodontal pockets, and this
      destruction can generate anatomical defects in the region of bifurcation. Treatment of these
      lesions is a challenge for the clinician, as this area has limited access to bacterial
      biofilm and calculus. The surgical regenerative therapy using bone grafts and membrane may be
      a viable option in cases of class II furcation defects. In this context, the objective of
      this case series is to evaluate tomographically and clinically the treatment of class II
      furcation defects using an absorbable collagen membrane (Bio-Gide® Perio) associated or not
      with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).
Periodontal disease is an infectious-inflammatory disease that accommodates the supporting
      and supporting tissues of the teeth, with the formation of periodontal pockets, and this
      destruction can generate anatomical defects in the region of bifurcation. Treatment of these
      lesions is a challenge for the clinician, as this area has limited access to bacterial
      biofilm and calculus. The surgical regenerative therapy using bone grafts and membrane may be
      a viable option in cases of class II furcation defects. In this context, the objective of
      this case series is to evaluate tomographically and clinically the treatment of class II
      furcation defects using an absorbable collagen membrane (Bio-Gide® Perio) associated or not
      with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen). In a parallel
      design, 22 patients with mandibular class II furcation defects were recruited. Each defect
      was randomly assigned to the control group (CG - Bio-Gide® Perio, n=11) or test group (TG -
      Bio-Oss® Collagen + Bio-Gide® Perio, n=11). Tomographic and clinical evaluations were
      conducted at baseline and 12 months post-surgery. Clinical measurements of clinical
      attachment level (CAL) and probing depth (PD). Tomographical measurements of horizontal
      defect dimension (HDD) and vertical defect dimension (VDD) were recorded. In sequence, guided
      tissue regeneration surgeries were conducted: Then, bone defect were debrided, , the collagen
      membranes (BioGide Perio®) were trimmed to cover the osseous defects and extended 3 mm
      apically and laterally to the adjacent bone and sutured with absorbable suture. In the Test
      Group, the defects were completely filled with bovine bone + porcine collagen (BioOss
      Collagen®). The flaps were then coronally positioned until completely covering the membranes
      and sutured. Shapiro-Wilk test was used to evaluate normality of the data, and showed a
      normal distribution. Then, t-Test was selected for inter-group and intragroup comparisons.
      Trans-surgical measurements were evaluated at Baseline. The other clinical and tomographic
      parameters were evaluated at Baseline and 12 months. For all analyzes, p <0.05 was
      considered.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In a parallel design, 22 patients with mandibular class II furcation defects were recruited. Each defect was randomly assigned to the control group (CG - Bio-Gide® Perio, n=11) or test group (TG - Bio-Oss® Collagen + Bio-Gide® Perio, n=11). Tomographic and clinical evaluations were conducted at baseline and 12 months post-surgery.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: to evaluate clinical attachment level
time frame: The clinical periodontal parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
description: Change from Baseline in clinical attachment level at +360 days
measure: Tomographic bone gain
time frame: The Tomographic bone gain parameter will be recorded at baseline (pre-intervention) and +360 days after the surgical periodontal therapy.]
description: Change from Baseline in bone gain at +360 days
arm group label: collagen membrane associated to anorganic bone
arm group type: Experimental
description: Complete debridement of the osseous defects and thorough scaling and root planing using mini curettes and ultrasonic scalers were performed. The sites were randomly selected for treatment with resorbable collagen membrane (Bio-Gide® Perio) associated to anorganic bovine bone matrix + collagen (Bio-Oss® Collagen) . The membranes were trimmed to cover the lesions and extended to the adjacent bone between 2 to 3 mm apically and laterally. They were then placed in position, 2 mm below the CEJ, and fixed in position using sling 5-0 vicryl sutures. The flaps were coronally positioned until completely covering the membranes without tension and sutured with 5-0 nylon sutures
arm group label: collagen membrane alone
arm group type: Active Comparator
description: Complete debridement of the osseous defects and thorough scaling and root planing using mini curettes and ultrasonic scalers were performed. The sites were randomly selected for treatment with resorbable collagen membrane (Bio-Gide® Perio). The membranes were trimmed to cover the lesions and extended to the adjacent bone between 2 to 3 mm apically and laterally. They were then placed in position, 2 mm below the CEJ, and fixed in position using sling 5-0 vicryl sutures. The flaps were coronally positioned until completely covering the membranes without tension and sutured with 5-0 nylon sutures
intervention type: Procedure
intervention name: guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.
description: Dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) associated with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).
arm group label: collagen membrane associated to anorganic bone
other name: GTR
intervention type: Procedure
intervention name: guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.
description: dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) alone.
arm group label: collagen membrane alone
other name: GTR
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Sergio Luis Scombatti de Souza
investigator title: Departament of Oral & Maxillofacial Surgery and Periodontology
mesh term: Bone Diseases
mesh term: Periodontal Diseases
mesh term: Furcation Defects
sharing ipd: Undecided