Polycaprolactone versus collagen membrane and 1-year clinical outcomes: A randomized controlled trial.

ABSTRACT

BACKGROUND: Polycaprolactone (PCL) is a synthetic aliphatic polyester widely used in biomedical applications with biodegradability in the body and promotes cell proliferation and differentiation. A newly developed bilayered PCL membrane was developed for possibly being used as a membrane in guided bone regeneration (GBR). PURPOSE: To compare the clinical efficacy between a newly developed bilayered PCL membrane with a Cytoplast™ RTM collagen membrane for GBR with simultaneous implant placement. MATERIALS AND METHODS: Twenty-four patients were randomized to PCL or RTM group, and a total of 24 dental implants were placed. Primary outcomes were patient mean buccal bone thickness (BBT) immediately postimplantation and at 6 months using cone-beam CT and soft tissue surface dimensional changes (STC) at crown insertion, 6 months, and 1 year after loading using intraoral scanner. Secondary outcomes included success rate, clinical parameters, healing index, implant stability, pink esthetic score, and marginal bone levels. RESULTS: The percentage of reduced BBT at 6 months was 32.38%, 25.94%, and 23.96% in the test group and 34.42%, 14.75%, and 6.34% in the control group at the corresponding levels. The mean difference of changed BBT associated with PCL membrane, when compared to collagen membrane, at 6 months was -0.02 ± 0.18 mm (95% confidence interval [CI] -0.40 to 0.35), 0.29 ± 0.28 mm (95% CI -0.29 to 0.87), and 0.62 ± 0.38 mm (95% CI -0.17 to 1.42) at 0, 2, and 4 mm from implant shoulder. Minimal loss of STC was observed in both groups up to 1 year of loading. The mean difference loss of surface dimensional change associated with PCL membrane, when compared to collagen membrane, at 1 year of loading was 0.31 ± 0.19 mm (95% CI -0.07 to 0.70), 0.22 ± 0.26 mm (95% CI -0.33 to 0.76), and 0.17 ± 0.30 mm (95% CI -0.45 to 0.78) at 0, 2, and 4 mm from implant shoulder. None of these differences were statistically significant (unpaired t-test, degrees of freedom [df] = 22; p > 0.05). CONCLUSION: Within the limits of this trial, both barrier membranes resulted in comparable outcomes for GBR with implant placement after 1 year in function. Further research is necessary with a larger sample size.