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Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

Primary Purpose

Gingiva Atrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Conventional Free Gingival Graft
'Mesh Free Gingival Graft
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingiva Atrophy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥18 years of age, systemically healthy, presence of ≥2 adjacent implants in both sides of the mandibles showing <2 mm of KM on the buccal aspects, subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM Full-Mouth Plaque Score (FMPS) <20%, Full-Mouth Bleeding Score (FMBS) <20%. Exclusion Criteria: pregnancy or lactation, tobacco smoking, uncontrolled medical condition, medication that can affect gingival conditions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Free Gingival Graft

    Meshed Free Gingival Graft

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes of Keratinized Mucosa width (KMW)
    Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa

    Secondary Outcome Measures

    Changes of Keratinized Mucosa Thickness (KMT)
    measured by a therapeutic probe with a rubber stop
    Patient Morbidity
    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')
    Patient Satisfaction
    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')

    Full Information

    First Posted
    September 7, 2023
    Last Updated
    September 15, 2023
    Sponsor
    Göteborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06037694
    Brief Title
    Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues
    Official Title
    Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Göteborg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingiva Atrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Free Gingival Graft
    Arm Type
    Active Comparator
    Arm 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 Title
    Meshed Free Gingival Graft
    Arm Type
    Experimental
    Arm 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(s)
    Conventional Free Gingival Graft
    Intervention Description
    Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.
    Intervention Type
    Procedure
    Intervention Name(s)
    'Mesh Free Gingival Graft
    Intervention Description
    Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.
    Primary Outcome Measure Information:
    Title
    Changes of Keratinized Mucosa width (KMW)
    Description
    Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa
    Time Frame
    up to 1 year
    Secondary Outcome Measure Information:
    Title
    Changes of Keratinized Mucosa Thickness (KMT)
    Description
    measured by a therapeutic probe with a rubber stop
    Time Frame
    up to 1 year
    Title
    Patient Morbidity
    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')
    Time Frame
    up to 2 weeks
    Title
    Patient Satisfaction
    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')
    Time Frame
    up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥18 years of age, systemically healthy, presence of ≥2 adjacent implants in both sides of the mandibles showing <2 mm of KM on the buccal aspects, subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM Full-Mouth Plaque Score (FMPS) <20%, Full-Mouth Bleeding Score (FMBS) <20%. Exclusion Criteria: pregnancy or lactation, tobacco smoking, uncontrolled medical condition, medication that can affect gingival conditions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivier Carcuac, DDS, PhD
    Phone
    556275575
    Ext
    00971
    Email
    olivier.carcuac@gu.se
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jan Derks, DDS, PhD
    Phone
    317863124
    Ext
    0046
    Email
    jan.derks@odontologi.gu.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Derks
    Organizational Affiliation
    Goteborg University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29926484
    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.
    Results Reference
    result
    PubMed Identifier
    35763021
    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.
    Results Reference
    result
    PubMed Identifier
    29275490
    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.
    Results Reference
    result
    PubMed Identifier
    32710810
    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.
    Results Reference
    result
    PubMed Identifier
    28153583
    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.
    Results Reference
    result
    PubMed Identifier
    37551510
    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.
    Results Reference
    result
    PubMed Identifier
    29498129
    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.
    Results Reference
    result

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    Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

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