3d-printable Biopolymers for Socket Preservation Technique: Soft Tissues Response. A Randomized Clinical Trial

Abstract

Objectives The aim of the present parallel clinical study is to evaluate the efficacy of 3D printed biopolymers compounded with osteoconductive material (beta-tricalcium phosphate and hydroxiapatite) for soft tissues closure after teeth extraction. Materials and Methods this study followed the CONSORTreporting guidelines 39 patients were treated with socket preservation using 3D printed biopolymers and randomly divided in 3 groups (Test 1, Test 2 and Control). All cases were treated without flap elevation, careful cleaning and courettage of the sites and then randomly sealed as follows: T1 a 3D printed disk of poli-D-lactic acid with 10% of hydroxyapatite; T2 : a 3D printed disk of poli- ε caprolactone with 20% of β-tricalcium phosphate; T3 : the socket was left open to heal. At baseline (extraction time) and 6 weeks after extraction the rate of exposure was evaluated and stratified according to the site ( anterior, posterior). Results No drop out were observed during the 6 weeks follow-up. All the sites underwent uneventful healing with no complications. Test 1 and Test 2 showed a full healing of the soft tissues with a reduction of the exposed area from 46.5 ± 8.25 mm² to 0.6 ± 0.84 mm² and from 47.1 ± 8.67 mm² to 0.6 ± 0.7 mm² respectively. The control Group exhibited a reduction from 45.6 ± 7.25 mm² to 1.2 ± 0.9 mm². Both Test 1 and 2 when compared to the Control group showed a statistically significant better healing (p < 0.05). No differences between Test and Control groups were noticed for anterior teeth. Conclusions The future focus of personalized medicine is to employ cost-competitive materials, such as bio-polymers and their compounds, along with 3D printing technology, to achieve precision, biocompatibility, and cost reduction. Both materials used in this study showed evidence to achieve the purpose. Ethical Guidelines: written informed consent was obtained from the participants of the study, as requested by Ethics Committee for Health Research Faculty of Dentistry, Universitas Trisakti with the following number 641/S3/KEPK/FKG/5/2023. Trial registration Registered on 04/03/2024 ISRCTN12199305