A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-month results.

Abstract

To compare connective tissue graft (CTG) with collagen matrix (CMX) in terms of changes over time in buccal soft tissue profile (BSP) when applied at single implant sites. Patients with a single tooth gap in the anterior maxilla and horizontal mucosa defect were enrolled in a multi-centre randomized controlled trial. All sites had a bucco-palatal bone dimension of at least 6 mm and received a single implant and immediate implant restoration using a full digital workflow. Sites 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 outcome was increase in BSP at T1 (immediately after operation) and T2 (3months) based on superimposed digital surface models. Secondary parameters included patient-reported clinical and aesthetic outcomes. Thirty patients were included per group (control: 50% females, mean age 50; test: 53% females, mean age 48). Even though surgeons applied thicker grafts when using CMX, sites treated with CMX demonstrated 0.78 mm (95% CI 0.41-1.14) more shrinkage between T1 and T2 than sites treated with CTG. The final increase in BSP was 1.15 mm (95% CI 0.88-1.43) for CTG and 0.85 mm (95% CI 0.58-1.13) for CMX. The mean difference of 0.30 mm (95% CI -0.01 to 0.61) at T2 in favour of CTG was of borderline significance (p=.054). There were no significant differences between the groups in terms of post-operative bleeding (p=.344), pain (p=.331), number of analgesics taken (p=.504), oedema (p=.227), and pink aesthetic score (p=.655). VAS for post-operative haematoma was 6.56 (95% CI 0.54-12.59) lower for CMX, and surgery time could be reduced by 9.03 min (95% CI 7.04-11.03) when applying CMX. However, CMX resulted in significantly more marginal bone loss (0.38 mm; 95% CI 0.15-0.60), deeper pockets (0.30 mm; 95% CI 0.06-0.54), and more mid-facial recession (0.75 mm; 95% CI 0.39-1.12) than CTG. CTG remains the gold standard for increasing soft tissue thickness at the buccal aspect of implants.