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

This 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 6 months as compared to extraction sockets without the scaffold.

Thirteen 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 6 months post-extraction, for the evaluation of bone resorption. At 6 months, 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 4-6 months later.

There 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.

The 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 6 months as compared to extraction sockets without the scaffold.