3D-Printable Biopolymers for Socket Preservation Technique: Soft Tissues Response: A Pilot Randomised Clinical Study.

Abstract

<h4>Background</h4>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 hydroxyapatite) for soft tissue closure after tooth extraction.<h4>Materials and methods</h4>this study followed the CONSORT reporting guidelines; 39 patients were treated with socket preservation using 3D-printed biopolymers and randomly divided into 3 groups (Test 1, Test 2, and Control). All cases were treated without flap elevation, careful cleaning and debridement of the sites, and then randomly sealed as follows: In T1, with a 3D-printed disk of poli-D-lactic acid with 10% of hydroxyapatite; in T2, using a 3D-printed disk of poli-ε caprolactone with 20% of β-tricalcium phosphate; and in 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).<h4>Results</h4>No dropouts were observed during the 6 weeks follow-up. All sites underwent uneventful healing with no complications. For posterior teeth, Test 1 and Test 2 showed 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 Tests 1 and 2, when compared to the Control group, showed statistically significant better healing (<i>p</i> < 0.05). Anterior teeth showed a complete closure of the socket 4 weeks after the extraction with no noticeable differences between Test and Control.<h4>Conclusions</h4>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 the Ethics Committee for Health Research Faculty of Dentistry, Universitas Trisakti, with the following number: 641/S3/KEPK/FKG/5/2023.