An exploratory clinical study evaluating safety and performance of a volume-stable collagen matrix with coronally advanced flap for single gingival recession treatment

Objective: To test the safety of a new volume-stable collagen matrix (VCMX) in combination with coronally advanced flap (CAF) for the treatment of single gingival recession. Material and methods: Ten patients were treated for single RT1 gingival recession. Complete and mean root coverage, gingival thickness and keratinized tissue height, patient-reported outcome measures (PROMs), and safety were assessed up to 180 days. Descriptive statistics were used to analyze the clinical parameters. Results: VCMX resulted to be safe with no serious adverse events in all patients. At 6 months, root coverage was 96.7% with 90% of defects exhibiting complete coverage. There was an increase in mean width of keratinized tissue (KT) (0.4 ± 0.8 mm) and in gingival thickness (GT) (0.4 ± 0.34 mm); however, the difference was not statistically significant compared to baseline parameters. Pain perception and pain-killer consumption were low and decreasing further at 7 days. Esthetic satisfaction for both patients and experts revealed excellent scores. Conclusions: VCMX is a safe and well-tolerated device for the treatment of single gingival recessions. In combination with CAF, it resulted in a high performance in terms of mean and complete root coverage, KT width, and GT increase. VCMX may reduce patient discomfort and post-operative morbidity. Clinical relevance: VCMX is a safe and stable substitute for the treatment of gingival recession in conjunction with coronally advanced technique.