Efficacy of a harvest graft substitute for recession coverage and soft tissue volume augmentation: A randomized controlled trial
Michael K. McGuire, Jim Janakievski, E. Todd Scheyer, Diego Velásquez, John C. Gunsolley, Rick Heard, Thiago Morelli
Abstract
Abstract 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 <0.0001. Both therapies produced significant soft tissue volume increases (84.8 ± 47.43 mm 3 control versus 48.90 ± 35.58 mm 3 test, P = 0.0006). The test, harvest graft substitute produced less postoperative pain and was preferred by patients at the 6‐month end point. All other end point measures were not significantly different. Conclusions VCMX+CAF root coverage was inferior to CTG+CAF but produced less morbidity and was preferred by patients. Case/patient selection and surgical technique appear key to achieving successful results with the harvest graft alternative.