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.