Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites (FGGvsBSG+CM)

Harvard Medical School (HMS and HSDM)

Status: Active, not recruiting

Conditions: Surgery

Treatments: Procedure: Conventional Free Gingival Graft Approach (FGG); Procedure: Buccal Strip Graft with a collagen matrix (bSG + CM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05844475

IRB23-0131

Details and patient eligibility

About

The study aims at comparing two different approaches for soft tissue augmentation at implants lacking keratinized and adherent mucosa width: the free gingival graft (FGG) vs the Buccal Strip Graft in combination with a xenogeneic collagen matrix (BSG + CM)

Full description

Conventional free gingival graft (FGG), serving as control group, will be compared to buccal strip gingival graft (BSG) in combination with a collagen matrix (CM), serving as test group, in terms of clinical, volumetric, ultrasonographic, and patient-reported outcomes related to soft tissue augmentation at implant sites lacking keratinized and adherent mucosa.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years,
• Periodontally and systemically healthy,
• Full-mouth plaque score and full-mouth bleeding ≤ 20% (measured at four sites per tooth),
• Presence of at least one dental implant with < 2 mm of KM and lack of firm/adherent mucosa,
• Presence of at least 4 mm of keratinized gingiva in two or more teeth nonadjacent to the implant to be treated,
• Implants diagnosed as healthy (Berglundh et al. 2018),
• The patient must be able to perform good oral hygiene.

Exclusion criteria

• Contraindications for surgery,
• Systemic condition (e.g. diabetes mellitus, HIV, cancer, etc) that could compromise wound healing,
• Patients pregnant or attempting to get pregnant (self-reported),
• Untreated periodontitis,
• Untreated peri-implant mucositis or peri-implantitis (Berglundh et al. 2018),
• Smoking,
• Allergy to collagen-based medical products or iodine,
• Previous free gingival graft procedure at the target site.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Free gingival graft (FGG)

Active Comparator group

Description:

Conventional free gingival graft, involving the harvesting of an epithelialized graft from the hard palate, which is then stabilized/sutured to the recipient site (implant).

Treatment:

Procedure: Conventional Free Gingival Graft Approach (FGG)

Buccal Strip Graft + Collagen matrix (bSG + CM)

Experimental group

Description:

Strip graft obtained from the buccal mucosa of a site showing abundant keratinized gingiva, combined with a collagen matrix. The bSG + CM graft is stabilized/sutured to the recipient site (implant).

Treatment:

Procedure: Buccal Strip Graft with a collagen matrix (bSG + CM)