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 <0.0001. Both therapies produced significant soft tissue volume increases (84.8 ± 47.43 mm2 control versus 48.90 ± 35.58 mm2 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.