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.