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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Harvard Medical School (HMS and HSDM)
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Sites showing KM≥ 2 mm and AM≥ 1 mm
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Lorenzo Tavelli
Assistant Professor
Harvard Medical School (HMS and HSDM)
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,
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Sites showing KM≥ 2 mm and AM≥ 1 mm
Time Frame: 6 and 12 months
Number of sites showing at least 2 mm of keratinized mucosa width (in millimeters) and at least of 1 mm of attached mucosa (in millimeters) (outcome expressed as a number)
Secondary Outcomes
- Volumetric change(6 and 12 months)
- KM width gain(6 and 12 months)
- Esthetic assessment(Baseline and 12 months)
- Post-operative morbidity(Daily, for the first 4 weeks after the procedure)
- Ultrasonographic strain elastography(Baseline, 3 months, 6 months and 12 months)
- AM gain(6 and 12 months)
- Ultrasonographic tissue perfusion(Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months)
- Treatment satisfaction(12 months)
- Mucosal thickness (MT) gain(6 and 12 months)