Buccal Graft + Collagen Matrix Versus Free Gingival Graft for Keratinized Mucosa Augmentation at Implant Sites
- Conditions
- Surgery
- Interventions
- Procedure: Conventional Free Gingival Graft Approach (FGG)Procedure: Buccal Strip Graft with a collagen matrix (bSG + CM)
- Registration Number
- NCT05844475
- Lead Sponsor
- Harvard Medical School (HMS and HSDM)
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Free gingival graft (FGG) Conventional Free Gingival Graft Approach (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). Buccal Strip Graft + Collagen matrix (bSG + CM) Buccal Strip Graft with a 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).
- Primary Outcome Measures
Name Time Method Sites showing KM≥ 2 mm and AM≥ 1 mm 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 Outcome Measures
Name Time Method Volumetric change 6 and 12 months Volumetric change occurring at the treated sites analyzed by superimposing digital impressions obtained using optical scanners at baseline and 6 months (expressed in mm\^3)
KM width gain 6 and 12 months Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters)
Esthetic assessment Baseline and 12 months Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the initial and last visit (expressed as a number)
Post-operative morbidity Daily, for the first 4 weeks after the procedure Patient-reported outcome assessed using a daily questionnaire first the first 4 weeks (expressed as a number using a 0-100 visual analogue scale \[VAS\])
Ultrasonographic strain elastography Baseline, 3 months, 6 months and 12 months Changes in the elasticity of the soft tissue over the healing assessed with ultrasonography (expressed as a ratio)
AM gain 6 and 12 months Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters)
Ultrasonographic tissue perfusion Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months Tissue perfusion changes over the healing assessed with ultrasonography (expressed in cm/s)
Treatment satisfaction 12 months Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number)
Mucosal thickness (MT) gain 6 and 12 months Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters)
Trial Locations
- Locations (1)
Harvard School of Dental Medicine
🇺🇸Boston, Massachusetts, United States