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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Gingival Recession, Localized

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective Tissue Graft<br>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<br>* Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a connective tissue graft harvested from the palate.<br>|
| Experimental: Meshed Connective Tissue Graft<br>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<br>* Multiple adjacent gingival recession defects will be covered by coronally advanced flap combined with a meshed connective tissue graft harvested from the palate.<br>Device: Meshing of Connective Tissue Graft<br>* The harvested connective tissue graft is meshed with a scalpel blade before being unfolded and placed on the recipient site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean mid-facial recession coverage (mRC) | Percentage of the exposed tooth root covered after surgical intervention | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Root Coverage (CRC) | Frequency of complete root coverage | up to 1 year | 
| Changes of Keratinized Tissue Width (KTW) | Measured as the distance from the muco-gingival-junction to the gingival margin | up to 1 year | 
| Changes of Gingival Thickness (GT) | Measured 3 mm apically from the free gingival margin at the mid-buccal aspect of the tooth | up to 1 year | 
| 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') | up to 2 weeks | 
| 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') | up to 1 year |