RESUMO
AIM: To compare connective tissue graft (CTG) with collagen matrix (CMX) in terms of increase in buccal soft tissue profile (BSP) when applied at single implant sites. MATERIALS AND METHODS: Patients with a single tooth gap in the anterior maxilla and horizontal mucosa defect were enrolled in a multi-centre randomized controlled trial. All were fully healed sites with a bucco-palatal bone dimension of at least 6 mm, and received an immediately restored single implant using a full digital workflow. Patients were randomly allocated to the control (CTG) or test group (CMX: Geistlich Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland) to increase buccal soft tissue thickness. Primary endpoints were increase in BSP at T1 (immediately postop), T2 (3 months), T3 (1 year) and T4 (3 years) based on superimposed digital surface models. Secondary endpoints included patient-reported, clinical and aesthetic outcomes. RESULTS: Thirty patients were included per group (control group: 15 males, 15 females, mean age 50.1 years; test group: 14 males, 16 females, mean age 48.2 years) and 50 could be re-examined at T4. The changes in BSP over time were significantly different between the groups (p < .001). At T4, the estimated mean increase in BSP amounted to 0.83 mm (95% confidence interval [CI]: 0.58-1.08) in the control group and 0.48 mm (95% CI: 0.22-0.73) in the test group. The estimated mean difference of 0.35 mm (95% CI: 0.06-0.65) in favour of the control group was significant (p = .021). No significant differences between the groups could be observed in terms of patients' aesthetic satisfaction (p = .563), probing depth (p = .286), plaque (p = .676), bleeding on probing (p = .732), midfacial recession (p = .667), Pink Esthetic Score (p = .366) and Mucosal Scarring Index (p = .438). However, CMX resulted in significantly more marginal bone loss (-0.43 mm; 95% CI: -0.77 to -0.09; p = .015) than CTG. CONCLUSIONS: CTG was more effective in increasing buccal soft tissue profile and resulted in less marginal bone loss than CMX. Therefore, CTG remains the gold standard to increase soft tissue thickness at implant sites. CLINICAL TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov (NCT04210596).
RESUMO
OBJECTIVE: The objective of this study is to assess profilometric changes following soft tissue augmentation with a cross-linked porcine-derived collagen matrix (CMX) at large edentulous gaps of at least two units. MATERIALS AND METHODS: Systemically healthy, nonsmoking patients with a large edentulous gap of at least two units demonstrating a horizontal soft tissue defect, were enrolled in a prospective case series. Soft tissue augmentation was performed in a one-stage approach with a 6 mm thick CMX at the time of implant placement. The primary outcome was the change in buccal soft tissue profile (BSP) at a mesial, central, and distal area of interest (AOI) up to 1 year when compared to the preoperative situation based on superimposed digital surface models. Secondary outcomes included the horizontal dimension of the soft tissue defect, complications, and marginal bone loss (MBL). RESULTS: Fifteen patients (eight females; mean age 58.73 years) were enrolled and 13 could be re-assessed at 1-year follow-up. The mean linear increase in BSP at 1 year was 0.66 mm (98.3% CI: 0.37-0.94), 0.80 mm (98.3% CI: 0.39-1.22), and 0.69 mm (98.3% CI: 0.32-1.06) at the mesial, central, and distal AOI, respectively. Substantial shrinkage of about 75% was observed in all areas between augmentation and 1-year follow-up. Even though 11 of 13 sites were fully augmented immediately postoperative, a soft tissue defect recurred in all sites at 1-year follow-up with a mean deficit of 2.30 mm. Altogether, 25% of the original soft tissue defect was eliminated by soft tissue augmentation. CMX was safe since no postoperative complications occurred and MBL was limited (0.70 mm). CONCLUSION: CMX is efficacious for horizontal soft tissue augmentation at large edentulous gaps. However, considerable graft resorption may be expected, and the clinical relevance of the augmentation may be questionable since all patients demonstrated a recurring and considerable soft tissue defect 1 year after surgery.
