Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues
- Conditions
- Gingiva Atrophy
- Interventions
- Procedure: 'Mesh Free Gingival GraftProcedure: Conventional Free Gingival Graft
- Registration Number
- NCT06037694
- Lead Sponsor
- Göteborg University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- ≥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%.
- pregnancy or lactation,
- tobacco smoking,
- uncontrolled medical condition,
- medication that can affect gingival conditions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meshed Free Gingival Graft 'Mesh Free Gingival Graft 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. Free Gingival Graft Conventional Free Gingival Graft 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.
- Primary Outcome Measures
Name Time Method Changes of Keratinized Mucosa width (KMW) up to 1 year Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa
- Secondary Outcome Measures
Name Time Method Changes of Keratinized Mucosa Thickness (KMT) up to 1 year measured by a therapeutic probe with a rubber stop
Patient Satisfaction 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')
Patient Morbidity 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')
Trial Locations
- Locations (1)
ConfiDent ® Dental Surgery Clinic, Dubai Palm Jumeirah
🇦🇪Dubai, United Arab Emirates