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

Abstract

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.

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Funding

The study was funded by Geistlich Pharma AG, Wolhusen, Switzerland.

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Correspondence to Martina Stefanini.

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Conflict of interest

Prof. Zucchelli Giovanni and Dr. Stefanini Martina received honorarium for speaking engagements with Geistlich. The other authors did not declare any conflict of interest.

Ethical approval

All procedures performed involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

For this type of study, informed consent was obtained from all individual participants included in the study.

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Stefanini, M., Mounssif, I., Barootchi, S. et al. An exploratory clinical study evaluating safety and performance of a volume-stable collagen matrix with coronally advanced flap for single gingival recession treatment. Clin Oral Invest 24, 3181–3191 (2020). https://doi.org/10.1007/s00784-019-03192-5

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Keywords

  • Volumetric stable collagen matrix
  • Gingival recession
  • Safety
  • Coronally advanced flap
  • Root coverage