search
Back to results

Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

Primary Purpose

Gingival Recession, Localized

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronally Advanced Flap combined with a Connective Tissue Graft
Coronally Advanced Flap combined with a Meshed Connective Tissue Graft
Meshing of Connective Tissue Graft
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession, Localized

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: age ≥18 years, systemically healthy, ≥3 adjacent RT1 recessions on both sides of the maxillary or mandibular arch with an apico-coronal extension (i.e. recession depth) >2 mm, 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

    Connective Tissue Graft

    Meshed Connective Tissue Graft

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Mean mid-facial recession coverage (mRC)
    Percentage of the exposed tooth root covered after surgical intervention

    Secondary Outcome Measures

    Complete Root Coverage (CRC)
    Frequency of complete root coverage
    Changes of Keratinized Tissue Width (KTW)
    Measured as the distance from the muco-gingival-junction to the gingival margin
    Changes of Gingival Thickness (GT)
    Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth
    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 3, 2023
    Last Updated
    October 5, 2023
    Sponsor
    Göteborg University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06030947
    Brief Title
    Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects
    Official Title
    Coronally Advanced Flap Combined With a Meshed Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects : a Multi-center Controlled Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 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 objective of this project is to evaluate short-term and 1-year outcomes of treatment of multiple adjacent gingival recession defects (MAGRD) using the coronally advanced flap (CAF) with either conventional CTG (control group) or meshed CTG (mesh-CTG) (test group).
    Detailed Description
    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 coronally advanced flap (CAF) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession, Localized

    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
    Connective Tissue Graft
    Arm Type
    Active Comparator
    Arm 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 Title
    Meshed Connective Tissue Graft
    Arm Type
    Experimental
    Arm 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(s)
    Coronally Advanced Flap combined with a Connective Tissue Graft
    Intervention Description
    Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.
    Intervention Type
    Procedure
    Intervention Name(s)
    Coronally Advanced Flap combined with a Meshed Connective Tissue Graft
    Intervention Description
    Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a meshed connective tissue graft harvested from the palate.
    Intervention Type
    Device
    Intervention Name(s)
    Meshing of Connective Tissue Graft
    Intervention Description
    The harvested connective tissue graft is meshed with a scalpel blade before being unfolded and placed on the recipient site.
    Primary Outcome Measure Information:
    Title
    Mean mid-facial recession coverage (mRC)
    Description
    Percentage of the exposed tooth root covered after surgical intervention
    Time Frame
    up to 1 year
    Secondary Outcome Measure Information:
    Title
    Complete Root Coverage (CRC)
    Description
    Frequency of complete root coverage
    Time Frame
    up to 1 year
    Title
    Changes of Keratinized Tissue Width (KTW)
    Description
    Measured as the distance from the muco-gingival-junction to the gingival margin
    Time Frame
    up to 1 year
    Title
    Changes of Gingival Thickness (GT)
    Description
    Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth
    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
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years, systemically healthy, ≥3 adjacent RT1 recessions on both sides of the maxillary or mandibular arch with an apico-coronal extension (i.e. recession depth) >2 mm, 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, DDS, PhD
    Organizational Affiliation
    Goteborg University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9118277
    Citation
    Consensus report. Mucogingival therapy. Ann Periodontol. 1996 Nov;1(1):702-6. doi: 10.1902/annals.1996.1.1.702. No abstract available.
    Results Reference
    result
    PubMed Identifier
    28758301
    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.
    Results Reference
    result
    PubMed Identifier
    24640999
    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.
    Results Reference
    result
    PubMed Identifier
    24641000
    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.
    Results Reference
    result
    PubMed Identifier
    24641002
    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.
    Results Reference
    result
    PubMed Identifier
    15455747
    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.
    Results Reference
    result

    Learn more about this trial

    Effectiveness of Meshed Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

    We'll reach out to this number within 24 hrs