Soft-Tissue Augmentation During Implant Placement in the Aesthetic Zone: Clinical, Radiographic, Histological and Patient-Reported Outcomes From a Randomised Controlled Trial Using Connective Tissue Graft and a Volume-Stable Collagen Matrix.
AIM To evaluate the clinical, radiographic, histological and patient-reported outcome measures (PROMs) of soft-tissue augmentation (STA) during implant placement in the aesthetic zone using a connective tissue graft (CTG) or a volume-stable collagen matrix (VCMX). MATERIALS AND METHODS In this three-arm randomised controlled trial, 25 patients were allocated to VCMX, SCTG, or no augmentation (control). Soft-tissue thickness (STT) was assessed by ultrasonography, and buccal bone thickness (BBT) by CBCT, at baseline and 6 months. Clinical parameters, PROMs and histological findings were recorded. Statistical analysis was performed at the patient level using repeated-measures general linear models, accounting for within-subject variability. RESULTS Both VCMX and SCTG resulted in significant increases in STT compared with control (p < 0.001). Numerically greater STT gains were observed in the VCMX group. BBT decreased significantly over time in all groups, with no significant differences between treatments. PROMs were comparable, although CTG was associated with slightly higher morbidity. Histological analysis showed favourable integration of both grafting materials. CONCLUSION STA significantly increased STT but did not prevent buccal bone remodelling. Within the study limitations, both augmentation approaches were associated with increased STT compared with no augmentation. Further well-designed studies are required to confirm these findings. TRIAL REGISTRATION This study is registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT06622759; URL: https://clinicaltrials.gov/study/NCT06622759).