Efficacy of a harvest graft substitute for recession coverage and soft tissue volume augmentation: A randomized controlled trial

Background The autogenous connective tissue graft (CTG) with coronally advanced flap (CTG+CAF) is the "gold standard" for recession defect coverage; however, researchers continue to pursue lower morbidity, more convenient and unlimited supply harvest graft substitutes, including those that could provide soft tissue volume augmentation. Methods A randomized, controlled, double‐masked comparison of a volume‐stable collagen matrix (VCMX) versus CTG was conducted at four clinical investigation sites. Single, contralateral, within patient matched‐pair, RT1 recession defects were treated with VCMX+CAF (test) and CTG+CAF (control). The primary efficacy end point was percent root coverage at 6 months. Secondary efficacy end points included clinical measures such as soft tissue volume, attachment level, and keratinized tissue width. Patient‐reported outcomes included measures such as discomfort, esthetics, and overall satisfaction; 6‐month end point results were followed for 1 year. Results Thirty patients received control and test therapies, and all patients were available for follow‐up measures. Average percent root coverage for CTG+CAF was 90.5% ± 14.87% versus 70.7% ± 28.26% for VCMX+CAF, P