A randomized controlled clinical trial to evaluate a new xenograft for alveolar socket preservation.

OBJECTIVE

The aim of this clinical trial was to compare the effect of Bio-Oss(®) and a new bovine xenograft (Osseus(®) ) in alveolar sockets after a 24-week healing period.

MATERIALS AND METHODS

A total of 20 adult volunteers ages 30-60 were subjected to single tooth extraction. A tooth extraction was performed at the baseline. All sites were randomly allocated to two test groups (TG1: grafted using a new bovine xenograft, Osseus(®) , and TG2: grafted using commercially available bovine xenograft-Bio-Oss(®) ). Six months later, a sample of the grafted area was obtained and implants were inserted in the same site. Histological sections were examined focusing on the presence of fibrous connective tissue (CT), and newly formed bone in direct contact with the graft. The HE-stained sections were subjected to histomorphometrical evaluation using Image Pro-Plus(®) software (Release 7.0). The definitive crown was placed 3 months later.

RESULTS

Upon completion of the study, no patients were removed from the study and all inserted implants (10 in each group) were eventually integrated. After 6 months, in the TG1, the mean value of new bone formation was 33.7 (± 7.1), for CT was 32.3 (± 8.9) and for the remaining biomaterial was 10.7 (± 16.2). In the TG2, the mean value of new bone formation was 19.3 (± 22.6), of the CT was 49.9 (± 14.1) and of the remaining biomaterial was 22.6 (± 7.9).

CONCLUSIONS

No statistically significant difference was observed between TG1 and TG2 after 6 months (P > 0.05), and both biomaterials afforded a more favorable implant position.