A Multi-Centre Randomized Controlled Trial Comparing Connective Tissue Graft with Collagen Matrix to Increase Buccal Soft Tissue Thickness: A Cone-Beam CT Analysis.

(1) Aim: a cross-linked porcine-derived collagen matrix (CMX) has been developed for soft tissue augmentation. Although this grafting material does not require a second surgical site, recent findings have indicated deeper pockets, more marginal bone loss and more midfacial recession in the short term when compared to connective tissue graft (CTG). Hence, the aim of the present study was to evaluate the safety of CMX based on buccal bone loss over a one-year period. (2) Methods: Patients who were missing a single tooth in the anterior maxilla were included, in whom the failing tooth had been removed at least 3 months prior and who presented a horizontal mucosa defect. All sites had a bucco-palatal bone dimension of at least 6 mm as assessed on Cone-Beam Computed Tomography (CBCT) to ensure complete embedding of an implant by bone. All patients received a single implant and an immediate implant restoration using a full digital workflow. Sites were randomly allocated to the control (CTG) or test group (CMX) to increase buccal soft tissue thickness. All surgeries were performed by means of full thickness mucoperiosteal flap elevation, placing CTG and CMX in contact with the buccal bone wall. Safety was assessed by evaluating the impact of CTG and CMX on buccal bone loss over a one-year period using superimposed CBCT scans. (3) Results: thirty patients were included per group (control: 50% females, mean age 50; test: 53% females, mean age 48) and 51 (control: 25; test: 26) could be analyzed for buccal bone loss. At 1 mm apical to the implant-abutment interface (IAI), most horizontal resorption was found pointing to 0.44 mm in the control group and 0.59 mm in the test group. The difference of 0.14 mm (95% CI: -0.17-0.46) was not statistically significant ( p = 0.366). At 3 mm and 5 mm apical to the IAI, the difference between the groups was 0.18 mm (95% CI: -0.05-0.40; p = 0.128) and 0.02 mm (95% CI: -0.24-0.28; p = 0.899), respectively. Vertical buccal bone loss amounted to 1.12 mm in the control group and 1.14 mm in the test group. The difference of 0.02 mm (95% CI: -0.53-0.49) was not statistically significant ( p = 0.926). (4) Conclusions: In the short term, soft tissue augmentation with CTG or CMX results in limited buccal bone loss. CMX is a safe alternative to CTG. Longer follow-up is needed to assess the impact of soft tissue augmentation on buccal bone.