<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/NCT03833765</url>
  </required_header>
  <id_info>
    <org_study_id>STXen</org_study_id>
    <nct_id>NCT03833765</nct_id>
  </id_info>
  <brief_title>Adjunctive Benefit of a Xenogenic Collagen Matrix</brief_title>
  <official_title>Adjunctive Benefit of a Xenogenic Collagen Matrix Associated With Coronally Advanced Flap for Treating Multiple Gingival Recessions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roberto Rotundo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Geistlich Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rotundo, Roberto, DDS</source>
  <oversight_info>
    <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>
      The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a&#xD;
      xenogenic collagen matrix in combination with a coronal advanced flap with respect to a&#xD;
      coronal advanced flap alone in the treatment of multiple gingival recession defects in adult&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-centre, superiority, double blind clinical trial, with balanced&#xD;
      randomisation and parallel two groups design. The 2 groups will be:&#xD;
&#xD;
        1. CAF combined with XCM;&#xD;
&#xD;
        2. CAF alone.&#xD;
&#xD;
      The objective is therefore to assess the adjunctive benefit of a xenogenic collagen matrix in&#xD;
      combination with a coronal advanced flap.&#xD;
&#xD;
      The primary endpoint is the mean recession reduction after 6 and 12 months post treatment.&#xD;
&#xD;
      The secondary endpoints are: Percentage of complete root coverage after 6 and 12 month;&#xD;
      Thickness of soft tissue over the root after 6 and 12 month; Recession width after 6 and 12&#xD;
      month; KT width; Patients satisfaction.&#xD;
&#xD;
      The following Inclusion Criteria have to be satisfied: patient (male or female) must be 18&#xD;
      years or older, not pregnant, and candidate for buccal root coverage procedure in the upper&#xD;
      jaw; recession defects have to be AAA or ABA (according to Rotundo et al classification),&#xD;
      with at least 2 adjacent RC with ≥ 2 mm RC depth and root abrasion depth less than 1 mm;&#xD;
      Patient shows sufficient plaque control (FMPS ≤ 20%) and acceptable bleeding score(FMBS ≤&#xD;
      20%); Teeth intended to treat are in the region 1 - 5; patient has to be able to comply with&#xD;
      the study-related procedures such as exercising good oral hygiene and attending all follow-up&#xD;
      procedures; patient is able to fully understand the nature of the proposed surgery and is&#xD;
      able to provide a signed informed consent.&#xD;
&#xD;
      Randomisation: Computer-generated blocked for each centre, with allocation concealment by&#xD;
      opaque sequentially numbered sealed envelopes.&#xD;
&#xD;
      Blinding: Patients and outcome assessor blind to group assignment.&#xD;
&#xD;
      Sample size: Based on a formula for cluster design to detect a difference between treatments&#xD;
      of 1 mm in recession reduction (standard deviation of 0.93 mm - Woodyard et al. 2004) with a&#xD;
      two-side 5% significance level, a power of 90%, a mean number of treated teeth per patient of&#xD;
      2.92, an intraclass correlation coefficient of 0.35, a sample size of 24 patients per&#xD;
      treatment will be necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2012</start_date>
  <completion_date type="Actual">July 17, 2017</completion_date>
  <primary_completion_date type="Actual">May 3, 2016</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>
    <intervention_model_description>single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design according to CONSORT statement</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Recession Reduction</measure>
    <time_frame>12 months</time_frame>
    <description>The distance between CEJ and the free gingival margin (Rec depth) will be measured at baseline, 3, 6 and 12 months. The mean change will be then calculated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>CAF+XCM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An envelope split-full-split thickness flap without vertical incisions will be carried out in the gingival recession area. Afterwards, a xenogenic collagen matrix (XCM) will be applied to all teeth with recession defect. The XCM will be cut into the right dimensions, measured with the probe, and its measurements recorded; then it will be placed from the CEJ to the bone crest on the recipient bed using single sutures, 7/0 PGA sutures. The matrix will be rehydrated with blood, in order to reconstitute and maintain the maximal thickness possible. The flap will be closed slightly coronal to the CEJ with a sling suture using resorbable PGA 6/0 sutures and avoiding any compression of the matrix.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAF alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An envelope split-full-split thickness flap without vertical incisions will be carried out. The root surfaces will be mechanically treated with the use of curettes. A sharp dissection into the vestibular lining mucosa will be then carried out to eliminate muscle tension. Sling sutures will be performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the de-epithelialized anatomic papillae.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF+XCM</intervention_name>
    <description>After flap elevation according to the Coronally Advanced Flap procedure for multiple recession defects, a Xenogeneic Collagen Matrix was applied and then covered by the flap.</description>
    <arm_group_label>CAF+XCM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CAF alone</intervention_name>
    <description>Coronally Advanced Flap procedure alone was performed to treat multiple recession defects</description>
    <arm_group_label>CAF alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient (male or female) must be 18 years or older&#xD;
&#xD;
          2. Presence of gingival recessions in the upper jaw, involving teeth from central incisor&#xD;
             to first molar&#xD;
&#xD;
          3. Gingival recessions on at least 2 adjacent teeth with a minimal depth of 2mm and&#xD;
             detectable cemento-enamel junction (CEJ) (abrasion step &lt;1mm)&#xD;
&#xD;
          4. The patient is able to comply with the study-related procedures such as exercising&#xD;
             good oral hygiene and attending all follow-up procedures&#xD;
&#xD;
          5. Full Mouth Plaque (FMPS) and Bleeding (FMBS) Score &lt;20%&#xD;
&#xD;
          6. The patient is able to fully understand the nature of the proposed surgery and is able&#xD;
             to provide a signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smoker patients&#xD;
&#xD;
          2. Pregnant patients&#xD;
&#xD;
          3. Patients affect by uncontrolled diabetes&#xD;
&#xD;
          4. General contraindications for dental and/or surgical treatment are present&#xD;
&#xD;
          5. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5&#xD;
             years&#xD;
&#xD;
          6. The patient is taking medications or having treatments which have an effect on mucosal&#xD;
             healing in general (e.g. steroids, large doses of anti-inflammatory drugs,&#xD;
             anticoagulation drugs)&#xD;
&#xD;
          7. The patient has a disease, which affects connective tissue metabolism (e.g.&#xD;
             collagenases)&#xD;
&#xD;
          8. The patient is allergic to collagen&#xD;
&#xD;
          9. The patient is an abuser of alcohol or drug&#xD;
&#xD;
         10. Patients have participated in a clinical trial within the last six months&#xD;
&#xD;
         11. Presence of untreated periodontitis&#xD;
&#xD;
         12. Gingival recessions on molar teeth (excluding the first) or on malpositioned teeth&#xD;
&#xD;
         13. Presence of abrasion ≥ 1 mm or cervical restoration, with non-detectable CEJ&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Rotundo, Roberto, DDS</investigator_affiliation>
    <investigator_full_name>Roberto Rotundo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>gingival recession</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 28, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03833765/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03833765
org study id: STXen
nct id: NCT03833765
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a
      xenogenic collagen matrix in combination with a coronal advanced flap with respect to a
      coronal advanced flap alone in the treatment of multiple gingival recession defects in adult
      population.
This is a single-centre, superiority, double blind clinical trial, with balanced
      randomisation and parallel two groups design. The 2 groups will be:

        1. CAF combined with XCM;

        2. CAF alone.

      The objective is therefore to assess the adjunctive benefit of a xenogenic collagen matrix in
      combination with a coronal advanced flap.

      The primary endpoint is the mean recession reduction after 6 and 12 months post treatment.

      The secondary endpoints are: Percentage of complete root coverage after 6 and 12 month;
      Thickness of soft tissue over the root after 6 and 12 month; Recession width after 6 and 12
      month; KT width; Patients satisfaction.

      The following Inclusion Criteria have to be satisfied: patient (male or female) must be 18
      years or older, not pregnant, and candidate for buccal root coverage procedure in the upper
      jaw; recession defects have to be AAA or ABA (according to Rotundo et al classification),
      with at least 2 adjacent RC with ≥ 2 mm RC depth and root abrasion depth less than 1 mm;
      Patient shows sufficient plaque control (FMPS ≤ 20%) and acceptable bleeding score(FMBS ≤
      20%); Teeth intended to treat are in the region 1 - 5; patient has to be able to comply with
      the study-related procedures such as exercising good oral hygiene and attending all follow-up
      procedures; patient is able to fully understand the nature of the proposed surgery and is
      able to provide a signed informed consent.

      Randomisation: Computer-generated blocked for each centre, with allocation concealment by
      opaque sequentially numbered sealed envelopes.

      Blinding: Patients and outcome assessor blind to group assignment.

      Sample size: Based on a formula for cluster design to detect a difference between treatments
      of 1 mm in recession reduction (standard deviation of 0.93 mm - Woodyard et al. 2004) with a
      two-side 5% significance level, a power of 90%, a mean number of treated teeth per patient of
      2.92, an intraclass correlation coefficient of 0.35, a sample size of 24 patients per
      treatment will be necessary.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design according to CONSORT statement
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Mean Recession Reduction
time frame: 12 months
description: The distance between CEJ and the free gingival margin (Rec depth) will be measured at baseline, 3, 6 and 12 months. The mean change will be then calculated.
arm group label: CAF+XCM
arm group type: Experimental
description: An envelope split-full-split thickness flap without vertical incisions will be carried out in the gingival recession area. Afterwards, a xenogenic collagen matrix (XCM) will be applied to all teeth with recession defect. The XCM will be cut into the right dimensions, measured with the probe, and its measurements recorded; then it will be placed from the CEJ to the bone crest on the recipient bed using single sutures, 7/0 PGA sutures. The matrix will be rehydrated with blood, in order to reconstitute and maintain the maximal thickness possible. The flap will be closed slightly coronal to the CEJ with a sling suture using resorbable PGA 6/0 sutures and avoiding any compression of the matrix.
arm group label: CAF alone
arm group type: Active Comparator
description: An envelope split-full-split thickness flap without vertical incisions will be carried out. The root surfaces will be mechanically treated with the use of curettes. A sharp dissection into the vestibular lining mucosa will be then carried out to eliminate muscle tension. Sling sutures will be performed to accomplish a precise adaptation of the buccal flap on the exposed root surfaces and to stabilize every single surgical papilla over the de-epithelialized anatomic papillae.
intervention type: Procedure
intervention name: CAF+XCM
description: After flap elevation according to the Coronally Advanced Flap procedure for multiple recession defects, a Xenogeneic Collagen Matrix was applied and then covered by the flap.
arm group label: CAF+XCM
intervention type: Procedure
intervention name: CAF alone
description: Coronally Advanced Flap procedure alone was performed to treat multiple recession defects
arm group label: CAF alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Rotundo, Roberto, DDS
investigator full name: Roberto Rotundo
investigator title: Principal Investigator
mesh term: Gingival Recession
provided document: 