Efficacy of a collagen matrix for soft tissue augmentation after implant placement compared to connective tissue grafts: A multicenter, noninferiority, randomized controlled trial.

Abstract

To test whether soft tissue volume augmentation using a collagen matrix (VCMX) leads to noninferior results in terms of gain of mucosal thickness at single implant sites, compared to connective tissue grafts (SCTG). The study was designed as a multi-center randomized controlled clinical trial. Subjects in need of soft tissue volume augmentation at single tooth implant sites were consecutively recruited at nine centers. The deficient mucosal thickness at the implant sites (one per patient) was augmented by applying either a VCMX or a SCTG. Patients were examined at 120 days (abutment connection = primary endpoint), 180 days (final restoration), and 360 days (1-year after insertion of the final restoration). Outcome measures included: transmucosal probing of the mucosal thickness (crestal = primary outcome), profilometric measurements of the tissue volume, and patient-reported outcome measures (PROMs). Out of the 88 patients, 79 attended the one-year follow-up. The median increase of the crestal mucosal thickness between pre-augmentation and 120 days was 0.3 ± 2.1 mm in the VCMX group and 0.8 ± 1.6 mm in the SCTG group (p = .455). Non-inferiority of the VCMX compared to the SCTG was not observed. The respective numbers at the buccal aspect amounted to 0.9 ± 2.0 mm (VCMX) and 1.1 ± 1.4 mm (SCTG; p = .431). PROMs including pain perception favored the VCMX group. It remains inconclusive whether soft tissue augmentation using a VCMX is noninferior to SCTG in terms of crestal mucosal thickening at single implant sites. However, the use of collagen matrices favors PROMs especially pain perception, while achieving similar buccal volume gains along with comparable clinical and aesthetic parameters to SCTG.