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| Name | Class |
|---|---|
| Osteology Foundation | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free gingival graft (FGG) | Active Comparator | 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) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Free Gingival Graft Approach (FGG) | Procedure | Conventional Free Gingival Graft Approach involving palatal soft tissue harvesting |
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| Measure | Description | Time Frame |
|---|---|---|
| Sites showing KM≥ 2 mm and AM≥ 1 mm | 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) | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| KM width gain | Gain in keratinized mucosa width obtained after the intervention compared to baseline (expressed in millimeters) | 6 and 12 months |
| AM gain | Gain in attached mucosa width obtained after the intervention compared to baseline (expressed in millimeters) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Tavelli, DDS, MS, PhD | Harvard School of Dental Medicine, Boston, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard School of Dental Medicine | Boston | Massachusetts | 02115 | United States |
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| Buccal Strip Graft with a collagen matrix (bSG + CM) | Procedure | 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 |
|
| 6 and 12 months |
| Mucosal thickness (MT) gain | Gain of mucosal thickness (MT) obtained after the intervention compared to baseline (expressed in millimeters) | 6 and 12 months |
| Volumetric change | 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) | 6 and 12 months |
| Ultrasonographic tissue perfusion | Tissue perfusion changes over the healing assessed with ultrasonography (expressed in cm/s) | Baseline, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months |
| Post-operative morbidity | 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]) | Daily, for the first 4 weeks after the procedure |
| Treatment satisfaction | Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the last visit (expressed as a number) | 12 months |
| Esthetic assessment | Patient-reported outcome assessed with questionnaire including a 0-100 visual analogue scale (VAS) at the initial and last visit (expressed as a number) | Baseline and 12 months |
| Ultrasonographic strain elastography | Changes in the elasticity of the soft tissue over the healing assessed with ultrasonography (expressed as a ratio) | Baseline, 3 months, 6 months and 12 months |