Clinical trial NCT05844475: Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites
Official title: Buccal Strip Gingival Graft With a Xenogeneic Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites: A Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: Osteology Foundation
First posted: 2023-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sites showing KM≥ 2 mm and AM≥ 1 mm
timeFrame: 6 and 12 months
Secondary outcomes:
measure: KM width gain
timeFrame: 6 and 12 months
measure: AM gain
timeFrame: 6 and 12 months
measure: Mucosal thickness (MT) gain
timeFrame: 6 and 12 months
measure: Volumetric change
timeFrame: 6 and 12 months
measure: Ultrasonographic tissue perfusion
timeFrame: Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months
measure: Post-operative morbidity
timeFrame: Daily, for the first 4 weeks after the procedure
measure: Treatment satisfaction
timeFrame: 12 months
measure: Esthetic assessment
timeFrame: Baseline and 12 months
measure: Ultrasonographic strain elastography
timeFrame: Baseline, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Medicine, Boston, USA
name: Lorenzo Tavelli, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: