xml: <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/NCT06030947</url>
    </required_header>
    <id_info>
      <org_study_id>OCarcuac-meshCTG</org_study_id>
      <nct_id>NCT06030947</nct_id>
    </id_info>
    <brief_title>Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects</brief_title>
    <official_title>Modified Tunnel Surgery Combined With a Meshed Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects : a Multi-center Controlled Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Göteborg University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Göteborg 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>
        The objective of this project is to evaluate short-term and 1-year outcomes of treatment of&#xD;
        multiple adjacent gingival recession defects (MAGRD) using the modified coronally advanced&#xD;
        tunnel (MCAT) with either conventional CTG (control group) or meshed CTG (mesh-CTG) (test&#xD;
        group).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gingival recession defects (GRD) present as a partial exposure of the root surface resulting&#xD;
        from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of&#xD;
        surgical methods have been reported to reestablish root coverage, including tunneling&#xD;
        techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the&#xD;
        predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts&#xD;
        (CTG) is often considered. CTG is thought to contribute to phenotype modification and&#xD;
        stability of treatment outcomes and studies have indicated favorable esthetic results and&#xD;
        high degrees of root coverage (documented range: 69% to 97%). The procedure does, however,&#xD;
        require a suitable donor site. When multiple adjacent teeth exhibit GRD, the preferred&#xD;
        surgical approach should offer the greatest root coverage while limiting drawback (i.e.,&#xD;
        patient morbidity, esthetic problems). Thus, one of the challenges related to root coverage&#xD;
        is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical&#xD;
        procedures may even be necessary. As an alternative, modification of the harvested CTG into&#xD;
        an expanded &quot;mesh CTG&quot; (mesh-CTG) has been proposed for the treatment of multiple adjacent&#xD;
        GRDs (MAGRD). However, the effectiveness and predictability of mesh-CTG using the modified&#xD;
        coronally advanced tunnel (MCAT) has not yet been evaluated in direct comparison to&#xD;
        conventional CTG.&#xD;
  &#xD;
        We hypothesise that no statistically significant differences will be observed in terms of&#xD;
        %root coverage and patient satisfaction at 12 months. Subjects in the test group (mesh-CTG)&#xD;
        will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to&#xD;
        controls.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2025</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, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean mid-facial recession coverage (mRC)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Percentage of the exposed tooth root covered after surgical intervention</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complete Root Coverage (CRC)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Frequency of complete root coverage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Keratinized Tissue Width (KTW)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Measured as the distance from the muco-gingival-junction to the gingival margin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes of Gingival Thickness (GT)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Morbidity</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Gingival Recession, Localized</condition>
    <arm_group>
      <arm_group_label>Connective Tissue Graft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A mucogingival surgery where a conventional connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Meshed Connective Tissue Graft</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A mucogingival surgery where a meshed connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Modified Coronally Advanced Tunnel combined with a Connective Tissue Graft</intervention_name>
      <description>Multiple adjacent gingival recession defects will be covered by modified coronally advanced tunnel combined with a connective tissue graft harvested from the palate.</description>
      <arm_group_label>Connective Tissue Graft</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Modified Coronally Advanced Tunnel combined with a Meshed Connective Tissue Graft</intervention_name>
      <description>Multiple adjacent gingival recession defects will be covered by modified coronally advanced tunnel combined with a meshed connective tissue graft harvested from the palate.</description>
      <arm_group_label>Meshed Connective Tissue Graft</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Meshing of Connective Tissue Graft</intervention_name>
      <description>The harvested connective tissue graft is meshed with a scalpel blade before being unfolded and placed on the recipient site.</description>
      <arm_group_label>Meshed Connective Tissue Graft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥18 years, systemically healthy, ≥3 adjacent RT1 recessions on both sides of the&#xD;
               maxillary or mandibular arch with an apico-coronal extension (i.e. recession depth) &gt;2&#xD;
               mm, Full-Mouth Plaque Score (FMPS) &lt;20%, Full-Mouth Bleeding Score (FMBS) &lt;20%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy or lactation, tobacco smoking, uncontrolled medical condition, medication&#xD;
               that can affect gingival conditions.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jan Derks, DDS, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Goteborg University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Olivier Carcuac, DDS, PhD</last_name>
      <phone>556275575</phone>
      <phone_ext>00971</phone_ext>
      <email>olivier.carcuac@gu.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jan Derks, DDS, PhD</last_name>
      <phone>317863124</phone>
      <phone_ext>0046</phone_ext>
      <email>jan.derks@odontologi.gu.se</email>
    </overall_contact_backup>
    <results_reference>
      <citation>Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available.</citation>
      <PMID>9118277</PMID>
    </results_reference>
    <results_reference>
      <citation>Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.</citation>
      <PMID>28758301</PMID>
    </results_reference>
    <results_reference>
      <citation>Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219.</citation>
      <PMID>24640999</PMID>
    </results_reference>
    <results_reference>
      <citation>Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.</citation>
      <PMID>24641000</PMID>
    </results_reference>
    <results_reference>
      <citation>Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172.</citation>
      <PMID>24641002</PMID>
    </results_reference>
    <results_reference>
      <citation>Cetiner D, Bodur A, Uraz A. Expanded mesh connective tissue graft for the treatment of multiple gingival recessions. J Periodontol. 2004 Aug;75(8):1167-72. doi: 10.1902/jop.2004.75.8.1167.</citation>
      <PMID>15455747</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingival Recession</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06030947
  org study id: OCarcuac-meshCTG
  nct id: NCT06030947
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this project is to evaluate short-term and 1-year outcomes of treatment of
        multiple adjacent gingival recession defects (MAGRD) using the modified coronally advanced
        tunnel (MCAT) with either conventional CTG (control group) or meshed CTG (mesh-CTG) (test
        group).
  Gingival recession defects (GRD) present as a partial exposure of the root surface resulting
        from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of
        surgical methods have been reported to reestablish root coverage, including tunneling
        techniques and coronally and laterally advanced flaps. As thin gingival tissue is one of the
        predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts
        (CTG) is often considered. CTG is thought to contribute to phenotype modification and
        stability of treatment outcomes and studies have indicated favorable esthetic results and
        high degrees of root coverage (documented range: 69% to 97%). The procedure does, however,
        require a suitable donor site. When multiple adjacent teeth exhibit GRD, the preferred
        surgical approach should offer the greatest root coverage while limiting drawback (i.e.,
        patient morbidity, esthetic problems). Thus, one of the challenges related to root coverage
        is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical
        procedures may even be necessary. As an alternative, modification of the harvested CTG into
        an expanded "mesh CTG" (mesh-CTG) has been proposed for the treatment of multiple adjacent
        GRDs (MAGRD). However, the effectiveness and predictability of mesh-CTG using the modified
        coronally advanced tunnel (MCAT) has not yet been evaluated in direct comparison to
        conventional CTG.
  
        We hypothesise that no statistically significant differences will be observed in terms of
        %root coverage and patient satisfaction at 12 months. Subjects in the test group (mesh-CTG)
        will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to
        controls.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Mean mid-facial recession coverage (mRC)
  time frame: up to 1 year
  description: Percentage of the exposed tooth root covered after surgical intervention
  measure: Complete Root Coverage (CRC)
  time frame: up to 1 year
  description: Frequency of complete root coverage
  measure: Changes of Keratinized Tissue Width (KTW)
  time frame: up to 1 year
  description: Measured as the distance from the muco-gingival-junction to the gingival margin
  measure: Changes of Gingival Thickness (GT)
  time frame: up to 1 year
  description: Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth
  measure: Patient Morbidity
  time frame: up to 2 weeks
  description: Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
  measure: Patient Satisfaction
  time frame: up to 1 year
  description: Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')
  arm group label: Connective Tissue Graft
  arm group type: Active Comparator
  description: A mucogingival surgery where a conventional connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.
  arm group label: Meshed Connective Tissue Graft
  arm group type: Experimental
  description: A mucogingival surgery where a meshed connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.
  intervention type: Procedure
  intervention name: Modified Coronally Advanced Tunnel combined with a Connective Tissue Graft
  description: Multiple adjacent gingival recession defects will be covered by modified coronally advanced tunnel combined with a connective tissue graft harvested from the palate.
  arm group label: Connective Tissue Graft
  intervention type: Procedure
  intervention name: Modified Coronally Advanced Tunnel combined with a Meshed Connective Tissue Graft
  description: Multiple adjacent gingival recession defects will be covered by modified coronally advanced tunnel combined with a meshed connective tissue graft harvested from the palate.
  arm group label: Meshed Connective Tissue Graft
  intervention type: Device
  intervention name: Meshing of Connective Tissue Graft
  description: The harvested connective tissue graft is meshed with a scalpel blade before being unfolded and placed on the recipient site.
  arm group label: Meshed Connective Tissue Graft
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Jan Derks, DDS, PhD
  role: Study Chair
  affiliation: Goteborg University
  last name: Olivier Carcuac, DDS, PhD
  phone: 556275575
  phone ext: 00971
  email: olivier.carcuac@gu.se
  last name: Jan Derks, DDS, PhD
  phone: 317863124
  phone ext: 0046
  email: jan.derks@odontologi.gu.se
  citation: Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available.
  PMID: 9118277
  citation: Cairo F. Periodontal plastic surgery of gingival recessions at single and multiple teeth. Periodontol 2000. 2017 Oct;75(1):296-316. doi: 10.1111/prd.12186.
  PMID: 28758301
  citation: Tonetti MS, Jepsen S; Working Group 2 of the European Workshop on Periodontology. Clinical efficacy of periodontal plastic surgery procedures: consensus report of Group 2 of the 10th European Workshop on Periodontology. J Clin Periodontol. 2014 Apr;41 Suppl 15:S36-43. doi: 10.1111/jcpe.12219.
  PMID: 24640999
  citation: Cairo F, Nieri M, Pagliaro U. Efficacy of periodontal plastic surgery procedures in the treatment of localized facial gingival recessions. A systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S44-62. doi: 10.1111/jcpe.12182.
  PMID: 24641000
  citation: Graziani F, Gennai S, Roldan S, Discepoli N, Buti J, Madianos P, Herrera D. Efficacy of periodontal plastic procedures in the treatment of multiple gingival recessions. J Clin Periodontol. 2014 Apr;41 Suppl 15:S63-76. doi: 10.1111/jcpe.12172.
  PMID: 24641002
  citation: Cetiner D, Bodur A, Uraz A. Expanded mesh connective tissue graft for the treatment of multiple gingival recessions. J Periodontol. 2004 Aug;75(8):1167-72. doi: 10.1902/jop.2004.75.8.1167.
  PMID: 15455747
  responsible party type: Sponsor
  mesh term: Gingival Recession
  sharing ipd: No