3D-Analysis of Peri-Implant Soft Tissue Gain With Collagen Matrix and Connective Tissue Graft: A Randomized Control Trial.

OBJECTIVES: To compare the efficacy of the connective tissue graft (SCTG) and the collagen matrix (VXCM) in terms of soft tissue gain at the buccal site around a single implant. METHODS: The study was designed as a randomized, controlled clinical trial. This trial was registered in ClinicalTrial.gov with the identifier NCT05870774 and is accessible under the following link: https://clinicaltrials.gov/study/NCT05870774?term=NCT05870774&rank=1. This clinical trial was not registered prior to participant recruitment and randomization. Patients with a single tooth gap and horizontal soft tissue thickness deficiency were enrolled in the study. Sites were randomly allocated to the control (SCTG) or test group (VXCM: Geistlich Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland) to augment buccal soft tissue thickness. The primary outcome was soft tissue gain 3 months post-op. Secondary outcomes included soft tissue gain 6 months post-op, the pink aesthetic score (PES), and patient-reported outcome measures (PROMs). RESULTS: Patients' recruitment started on 28 October 2021 and ended on 25 December 2022. Thirty-two patients were enrolled and subjected to intervention. Sixteen patients were included per group. Three months post-op, soft tissue gain at the buccal site was 1.77 +/- 0.61 mm in the VXCM group and 1.26 +/- 0.41 mm in the SCTG group (p = 0.0003). Six months post-op, soft tissue gain was 1.11 +/- 0.44 mm in the VXCM group and 1.43 +/- 0.81 mm in the SCTG group (p = 0.0459). PROMs, including pain perception, favored the VXCM group. SCTG demonstrated favored results in PES. CONCLUSION: SCTG remains the gold standard for increasing soft tissue thickness in terms of the clinical result.