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/NCT06037694</url>
    </required_header>
    <id_info>
      <org_study_id>OCarcuac-meshFGG</org_study_id>
      <nct_id>NCT06037694</nct_id>
    </id_info>
    <brief_title>Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues</brief_title>
    <official_title>Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled 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 overall objective of this project is to evaluate, over a period of 1 year, the outcomes&#xD;
        of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of&#xD;
        keratinized mucosa (KM) at implant sites.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The importance of the width of keratinized mucosa (KM) at implant sites remains a subject of&#xD;
        ongoing debate. Reduced dimensions of KM (width &lt;2 mm) are associated with mucosal recession,&#xD;
        biofilm accumulation, soft-tissue inflammation, marginal bone loss, peri-implantitis and&#xD;
        patient discomfort. Surgical options to increase the width of KM include an apically&#xD;
        positioned flap, either alone or in combination with an autogenous graft or a xenogeneic&#xD;
        collagen matrix. The free gingival graft (FGG) is a well-established technique with a history&#xD;
        of successful clinical use. The harvesting procedure for autogenous graft from the palatal&#xD;
        mucosa, however, is usually associated with significant patient morbidity, especially when&#xD;
        there is a need to graft extensive mucosal areas. To overcome this problem, various graft&#xD;
        modifications have been proposed to limit the need for large-area autografts. Examples&#xD;
        include the accordion technique, the strip gingival autograft technique, and a vertical&#xD;
        modification of the strip gingival graft. The expanded mesh graft, another graft&#xD;
        modification, has been used in the field of plastic surgery, especially in the treatment of&#xD;
        large burn wounds. Recently, De Greef, Carcuac, De Mars et al. proposed this technique to be&#xD;
        used in periodontal plastic surgery, more specifically, in the widening of KM at implant&#xD;
        sites by means of a meshed free gingival graft (mesh-FGG). In this case series, initially&#xD;
        inadequate width of KM in edentulous areas could be successfully increased prior to implant&#xD;
        installation, without the need for any extensive autograft harvesting. Data from trials&#xD;
        comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel&#xD;
        technique, however, are missing.&#xD;
  &#xD;
        The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical&#xD;
        results (non-inferiority: increase in KM width) but improved patient-reported outcomes&#xD;
        (superiority: post-surgical morbidity) compared to the FGG.&#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>Changes of Keratinized Mucosa width (KMW)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes of Keratinized Mucosa Thickness (KMT)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>measured by a therapeutic probe with a rubber stop</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>Gingiva Atrophy</condition>
    <arm_group>
      <arm_group_label>Free Gingival Graft</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>A mucogingival surgery where a conventional free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Meshed Free Gingival Graft</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A mucogingival surgery where a meshed free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional Free Gingival Graft</intervention_name>
      <description>Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.</description>
      <arm_group_label>Free Gingival Graft</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>'Mesh Free Gingival Graft</intervention_name>
      <description>Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.</description>
      <arm_group_label>Meshed Free Gingival Graft</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years of age,&#xD;
  &#xD;
            -  systemically healthy,&#xD;
  &#xD;
            -  presence of ≥2 adjacent implants in both sides of the mandibles showing &lt;2 mm of KM on&#xD;
               the buccal aspects,&#xD;
  &#xD;
            -  subjects have to present with discomfort from brushing and/or difficulties in&#xD;
               maintaining proper home care due to inadequate dimension of KM&#xD;
  &#xD;
            -  Full-Mouth Plaque Score (FMPS) &lt;20%,&#xD;
  &#xD;
            -  Full-Mouth Bleeding Score (FMBS) &lt;20%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy or lactation,&#xD;
  &#xD;
            -  tobacco smoking,&#xD;
  &#xD;
            -  uncontrolled medical condition,&#xD;
  &#xD;
            -  medication that can affect gingival conditions.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jan Derks</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>Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.</citation>
      <PMID>29926484</PMID>
    </results_reference>
    <results_reference>
      <citation>Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.</citation>
      <PMID>35763021</PMID>
    </results_reference>
    <results_reference>
      <citation>Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s00784-017-2320-y. Epub 2017 Dec 23.</citation>
      <PMID>29275490</PMID>
    </results_reference>
    <results_reference>
      <citation>Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.1002/JPER.19-0716. Epub 2020 Aug 9.</citation>
      <PMID>32710810</PMID>
    </results_reference>
    <results_reference>
      <citation>Singh M, Nuutila K, Collins KC, Huang A. Evolution of skin grafting for treatment of burns: Reverdin pinch grafting to Tanner mesh grafting and beyond. Burns. 2017 Sep;43(6):1149-1154. doi: 10.1016/j.burns.2017.01.015. Epub 2017 Jan 30.</citation>
      <PMID>28153583</PMID>
    </results_reference>
    <results_reference>
      <citation>De Greef A, Carcuac O, De Mars G, Stankov V, Cortasse B, Giordani G, Van Dooren E. The expanded mesh free gingival graft: A novel approach to increase the width of keratinized mucosa. Clin Adv Periodontics. 2023 Aug 8. doi: 10.1002/cap.10264. Online ahead of print.</citation>
      <PMID>37551510</PMID>
    </results_reference>
    <results_reference>
      <citation>Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.</citation>
      <PMID>29498129</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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/NCT06037694
  org study id: OCarcuac-meshFGG
  nct id: NCT06037694
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The overall objective of this project is to evaluate, over a period of 1 year, the outcomes
        of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of
        keratinized mucosa (KM) at implant sites.
  The importance of the width of keratinized mucosa (KM) at implant sites remains a subject of
        ongoing debate. Reduced dimensions of KM (width <2 mm) are associated with mucosal recession,
        biofilm accumulation, soft-tissue inflammation, marginal bone loss, peri-implantitis and
        patient discomfort. Surgical options to increase the width of KM include an apically
        positioned flap, either alone or in combination with an autogenous graft or a xenogeneic
        collagen matrix. The free gingival graft (FGG) is a well-established technique with a history
        of successful clinical use. The harvesting procedure for autogenous graft from the palatal
        mucosa, however, is usually associated with significant patient morbidity, especially when
        there is a need to graft extensive mucosal areas. To overcome this problem, various graft
        modifications have been proposed to limit the need for large-area autografts. Examples
        include the accordion technique, the strip gingival autograft technique, and a vertical
        modification of the strip gingival graft. The expanded mesh graft, another graft
        modification, has been used in the field of plastic surgery, especially in the treatment of
        large burn wounds. Recently, De Greef, Carcuac, De Mars et al. proposed this technique to be
        used in periodontal plastic surgery, more specifically, in the widening of KM at implant
        sites by means of a meshed free gingival graft (mesh-FGG). In this case series, initially
        inadequate width of KM in edentulous areas could be successfully increased prior to implant
        installation, without the need for any extensive autograft harvesting. Data from trials
        comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel
        technique, however, are missing.
  
        The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical
        results (non-inferiority: increase in KM width) but improved patient-reported outcomes
        (superiority: post-surgical morbidity) compared to the FGG.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Changes of Keratinized Mucosa width (KMW)
  time frame: up to 1 year
  description: Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa
  measure: Changes of Keratinized Mucosa Thickness (KMT)
  time frame: up to 1 year
  description: measured by a therapeutic probe with a rubber stop
  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: Free Gingival Graft
  arm group type: Active Comparator
  description: A mucogingival surgery where a conventional free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.
  arm group label: Meshed Free Gingival Graft
  arm group type: Experimental
  description: A mucogingival surgery where a meshed free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.
  intervention type: Procedure
  intervention name: Conventional Free Gingival Graft
  description: Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.
  arm group label: Free Gingival Graft
  intervention type: Procedure
  intervention name: 'Mesh Free Gingival Graft
  description: Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.
  arm group label: Meshed Free Gingival Graft
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Jan Derks
  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: Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.
  PMID: 29926484
  citation: Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.
  PMID: 35763021
  citation: Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s00784-017-2320-y. Epub 2017 Dec 23.
  PMID: 29275490
  citation: Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.1002/JPER.19-0716. Epub 2020 Aug 9.
  PMID: 32710810
  citation: Singh M, Nuutila K, Collins KC, Huang A. Evolution of skin grafting for treatment of burns: Reverdin pinch grafting to Tanner mesh grafting and beyond. Burns. 2017 Sep;43(6):1149-1154. doi: 10.1016/j.burns.2017.01.015. Epub 2017 Jan 30.
  PMID: 28153583
  citation: De Greef A, Carcuac O, De Mars G, Stankov V, Cortasse B, Giordani G, Van Dooren E. The expanded mesh free gingival graft: A novel approach to increase the width of keratinized mucosa. Clin Adv Periodontics. 2023 Aug 8. doi: 10.1002/cap.10264. Online ahead of print.
  PMID: 37551510
  citation: Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.
  PMID: 29498129
  responsible party type: Sponsor
  mesh term: Gingival Recession
  sharing ipd: No