Prospective follow-up study of 95 patients with edentulous mandibles treated according to the Brånemark Novum concept.

BACKGROUND

The long-term predictability reported with the traditional two-staged Brånemark method has led to developments aimed at simplifying the technique and reducing healing time. Results from a pilot study using the Brånemark Novum concept are promising, and it has been shown possible to fabricate and deliver an implant-supported fixed prosthesis to the patient on the day of surgery.

PURPOSE

The objective of this study is to report clinical and radiographic outcomes in a group of patients treated according to the Brånemark Novum concept.

MATERIALS AND METHODS

Ninety-five patients with edentulous mandibles were consecutively included in the study. Three specially designed fixtures were placed in each patient (285 fixtures in total) using drilling templates. The fixtures were immediately splinted with a prefabricated substructure, and fixed prostheses were delivered the same day in 67% of the patients. For the rest, prosthesis delivery ranged from 1 to 40 days (mean 5.6 d). Clinical and radiographic examinations were performed after 3 months, 6 months, 1 year, and then annually. The follow-up time was 1 to 5 years (mean 2.5 yr).

RESULTS

The cumulative prosthesis survival rate was 99%. Eighteen fixtures (6.3%) failed in 13 patients. Kaplan-Meier survival estimates demonstrated a probability implant survival at 1 year of 95.0% (94 patients), at 3 years of 93.3% (47 patients), and at 5 years of 93.3% (9 patients). The mean bone loss was 0.73 mm between the examinations at 3 months and 1 year, 0.16 mm during the second year, and 0.13 mm annually during years 3 to 5.

CONCLUSIONS

Comparable results, related to continuous prosthesis stability, were shown for the Novum approach compared with the traditional two-staged procedure. Survival of individual fixtures is lower when immediate loading is applied.