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

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ClinicalTrials.gov Identifier: NCT06030947
Recruitment Status : Not yet recruiting
First Posted : September 11, 2023
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Gingival Recession, Localized Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft Procedure: Coronally Advanced Flap combined with a Meshed Connective Tissue Graft Device: Meshing of Connective Tissue Graft Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : August 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Connective Tissue Graft
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.
 Procedure: Coronally Advanced Flap combined with a Connective Tissue Graft
Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.
Experimental: Meshed Connective Tissue Graft
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.
 Procedure: Coronally Advanced Flap combined with a Meshed Connective Tissue Graft
Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a meshed connective tissue graft harvested from the palate.

Device: Meshing of Connective Tissue Graft
The harvested connective tissue graft is meshed with a scalpel blade before being unfolded and placed on the recipient site.


Outcome Measures
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Primary Outcome Measures :
  1. Mean mid-facial recession coverage (mRC) [ Time Frame: up to 1 year ]
    Percentage of the exposed tooth root covered after surgical intervention


Secondary Outcome Measures :
  1. Complete Root Coverage (CRC) [ Time Frame: up to 1 year ]
    Frequency of complete root coverage

  2. Changes of Keratinized Tissue Width (KTW) [ Time Frame: up to 1 year ]
    Measured as the distance from the muco-gingival-junction to the gingival margin

  3. Changes of Gingival Thickness (GT) [ Time Frame: up to 1 year ]
    Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth

  4. Patient Morbidity [ Time Frame: up to 2 weeks ]
    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')

  5. Patient Satisfaction [ Time Frame: up to 1 year ]
    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')


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030947


Contacts
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Contact: Olivier Carcuac, DDS, PhD 556275575 ext 00971 olivier.carcuac@gu.se
Contact: Jan Derks, DDS, PhD 317863124 ext 0046 jan.derks@odontologi.gu.se

Sponsors and Collaborators
Göteborg University
Investigators
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Study Chair: Jan Derks, DDS, PhD Goteborg University
More Information
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Publications of Results:

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT06030947    
Other Study ID Numbers: OCarcuac-meshCTG
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy