Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites
NCT ID: NCT05844475
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
32 participants
INTERVENTIONAL
2023-04-13
2025-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Free gingival graft (FGG)
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).
Conventional Free Gingival Graft Approach (FGG)
Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting
Buccal Strip Graft + Collagen matrix (bSG + CM)
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).
Buccal Strip Graft with a collagen matrix (bSG + CM)
A small strip of keratinized gingiva is harvested from the buccal gingiva of a site showing abundant keratinized gingiva, and combined with a xenogeneic collagen matrix
Interventions
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Conventional Free Gingival Graft Approach (FGG)
Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting
Buccal Strip Graft with a collagen matrix (bSG + CM)
A small strip of keratinized gingiva is harvested from the buccal gingiva of a site showing abundant keratinized gingiva, and combined with a xenogeneic collagen matrix
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Osteology Foundation
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Responsible Party
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Lorenzo Tavelli
Assistant Professor
Principal Investigators
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Lorenzo Tavelli, DDS, MS, PhD
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Dental Medicine, Boston, USA
Locations
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Harvard School of Dental Medicine
Boston, Massachusetts, United States
Countries
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Other Identifiers
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IRB23-0131
Identifier Type: -
Identifier Source: org_study_id
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