Bioglass in Alveolar Bone Regeneration in Orthodontic Patients: Randomized Controlled Clinical Trial.

This study was designed as a split-mouth randomized controlled clinical trial to evaluate the effects of a novel bioactive glass scaffold-tailored amorphous multiporous (TAMP)-for the preservation of alveolar bone following tooth extraction in class II orthodontic patients. TAMP scaffolds were prepared and sterilized. Patients were screened for eligibility, and 6 patients accounting for 14 extraction sockets were included in this stage. Sockets were randomly allocated to either control (left empty) or test (grafted with TAMP scaffold particles). Follow-up was done after 1, 2, 4, 8, and 12 to 17 wk with digital periapical radiographs to evaluate changes in crestal bone height and bone mineral density (BMD), 3-dimensional volumetric analysis of impression casts, and histologic analysis of core biopsies. Furthermore, alveolar bone marrow mesenchymal stem cells were cultured from control and test sockets following biopsy retrieval to evaluate the ability of TAMP bioactive glass scaffolds to recruit host progenitor cells. Results showed that sockets grafted with TAMP bioactive glass scaffolds better preserved height after 3 mo where mesially 57.1% of test cases showed preservation of socket height, compared with 28.6% of control cases. Distally, this was 42.9% of test cases versus none of the control cases. Regarding BMD, the test sides had higher BMD in all 3 sections of the socket, with the greatest reduction in BMD found in the coronal third. Results were not statistically significant. Histologically, sockets grafted with TAMP bioactive glass scaffolds showed a distinct pattern of bone healing characterized by vertical trabeculae and large vascularized marrow spaces with sockets showing corticalization. Volumetric analysis showed a better preservation of socket contour with TAMP bioactive glass scaffolds. TAMP bioactive glass scaffolds appeared to enhance the recruitment of stem cells from the grafted sockets. In conclusion, TAMP scaffolds appear to better preserve alveolar bone following extraction and allow for a more active bone modeling and remodeling process( ClinicalTrials.gov identifier:NCT01878084). Knowledge Transfer statement: The results of this study set the stage for the recommended use of novel biomimetic scaffolds, such as the tailored amorphous multiporous bioactive glass for preservation of the socket following extraction. This can be valuable for patients and clinicians alike when deciding on long-term prosthetic alternatives that not only result in immediate bone preservation but will accommodate the dynamic nature of bone.

RCT Entities:   Population Interventions Outcomes