Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

Göteborg University

Status: Enrolling

Conditions: Gingiva Atrophy

Treatments: Procedure: Conventional Free Gingival Graft; Procedure: 'Mesh Free Gingival Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT06037694

OCarcuac-meshFGG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Free Gingival Graft

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional Free Gingival Graft

Meshed Free Gingival Graft

Experimental group

Description:

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.

Treatment:

Procedure: 'Mesh Free Gingival Graft