Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

Study Overview
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Brief Summary
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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
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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.

Official Title
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Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled Trial.

Conditions
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Gingiva Atrophy

Intervention / Treatment
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* Procedure: Conventional Free Gingival Graft
* Procedure: 'Mesh Free Gingival Graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Free Gingival Graft<br>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. | Procedure: Conventional Free Gingival Graft<br>* Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.<br>|
| Experimental: Meshed Free Gingival Graft<br>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. | Procedure: 'Mesh Free Gingival Graft<br>* Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Keratinized Mucosa width (KMW) | Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Keratinized Mucosa Thickness (KMT) | measured by a therapeutic probe with a rubber stop | 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 |