Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh

Abstract

Objective: Development of new custom-made devices to reconstruct alveolar bone for implantation, and comparison with conventional methods were the goals of this study.

Materials and methods: Using a computer-aided design technique, three-dimensional images were constructed. From these data, custom-made devices were produced by a selective laser melting method with pure titanium. Clinical trials also have been conducted with 26 participants who needed bone reconstruction before implantation; they were divided into 2 groups with 13 patients each. The first group uses custom-made devices; the other uses commercial titanium meshes that need to bend during operation. Some clinical aspects are evaluated after the trial.

Results: The custom-made devices can be produced closely by following the data precisely. Devices are fit for bone defect site. Moreover, the operation time of the custom-made group (75.4 ± 11.6 min) was significantly shorter than that of the conventional group (111.9 ± 17.8 min) (p < 0.01). Mucosal rupture occurs, without significant difference (p = 0.27), in a patient in the custom-made without severe infection (7.7%), and 3 in conventional (23.1%), respectively. The retaining screw is significantly fewer in the custom-made group than commercial mesh group (p < 0.01).

Conclusion: These results indicate that our novel protocol could be simple and safe for providing powerful support for guided bone regeneration.

Keywords: Clinical trial; Computer aided design; Custom-made device; Guided bone regeneration; Rapid prototyping; Selective laser melting.