Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial

Background Using a single‐blind, randomized, controlled, multicenter, practice‐based clinical trial, a volume‐stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants. Methods Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient‐reported outcomes (PRO). Results There were no significant differences between test and control patient demographics or clinical measures throughout the 1‐year study. VCMX “grafts” were by design larger than CTG, and surgery time was less (27% less, p = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (p