Novel 3D polycaprolactone scaffold for ridge preservation - a pilot randomised controlled clinical trial

ObjectivesThis pilot randomised controlled clinical trial aimed to evaluate the feasibility and effectiveness of using a polycaprolactone (PCL) scaffold in fresh extraction sockets for ridge preservation. The hypothesis was that the insertion of a 3D bioresorbable PCL scaffold in fresh extraction sockets allowed for normal bone healing and better maintenance of ridge dimensions after 6months as compared to extraction sockets without the scaffold. Material and methodsThirteen patients were randomised to either the test group (N=6) where a PCL scaffold was inserted in the tooth socket after extraction or the control group (N=7) where no space filler was used. Alveolar ridge height and width measurements were made at baseline and 6months post-extraction, for the evaluation of bone resorption. At 6months, a core of bone was trephined out from the healed ridge for microcomputed tomographic (micro CT) and histological analyses, immediately before Stage I dental implant surgery. Stage II dental implant surgery was performed 4-6months later. ResultsThere was less vertical ridge resorption in the test group compared to the control group, and the difference was statistically significant in the mesio-buccal aspect (P=0.008). Micro CT and histological observations showed mainly mineralised bone formation in both groups, except for one specimen in the test group. ConclusionsThe insertion of a 3D bioresorbable PCL scaffold in fresh extraction sockets allowed for normal bone healing, and there was better maintenance of ridge height after 6months as compared to extraction sockets without the scaffold.