A randomized, multicenter, double-blinded parallel study to evaluate the safety and performance of zoledronate-coated versus uncoated dental implants in partially edentulous patients.

OBJECTIVE: To evaluate patient safety, implants survival and implant stability of the bisphosphonate (zoledronate) as a coating on dental implants in patients requiring oral rehabilitation in the posterior maxilla. MATERIALS AND METHODS: In this multicenter, double-blind, randomized controlled study, 62 patients were randomized to receive either zoledronate-coated or uncoated control implants in the premolar or molar area of the maxilla, using a one stage-protocol. Due to dropouts and exclusion 49 patients completed the study. The implants were examined by resonance frequency analysis (RFA) using an implant stability quotient (ISQ) scale at the time of insertion, and at 8 weeks, and after 12 weeks prior to prosthetic restoration. Radiographs were taken prior to surgery, directly after insertion, and during the follow-up at 12 weeks, 6 months, and 1 year to analyze changes in marginal bone levels (MBL). Finally, all complications and adverse effects (AE) were observed and recorded. RESULTS: Out of 62 included patients, 49 patients completed the study. No AE were reported by patients receiving zoledronate-coated implants. There was no statistically significant difference between the zoledronate-coated or uncoated implant groups when comparing ISQ levels at insertion and after 12 weeks of healing, the mean of the ISQ values demonstrated a change of 4.64 (95% confidence interval: 15.46; 5.79, p = 0.43) between the two groups. At 8- and 12-weeks, ISQ values remained stable (range 62-70). Radiographic analysis showed no statistically significant difference in MBL between the two implant groups after 1 year of loading neither at the mesial side (p = 0.99) or the distal side (p = 0.97). MBL for coated implants were 0.57 mm at the mesial side and 0.46 mm at the distal side. For the uncoated implants, MBL was 0.48 mm at the mesial side and 0.47 mm at the distal side. CONCLUSION: The zoledronate-coated dental implants are safe to use in a one-stage surgery protocol in patients requiring oral rehabilitation in the posterior maxilla, after 1 year of loading. There were no statically significant changes in implant stability and marginal bone levels measured by intraoral radiographs in comparison to uncoated control implants.

Initial and long-term crestal bone responses to modern dental implants.

Successful osseointegration is the result of a controlled foreign body reaction to dental implants. Osseointegrated implants have demonstrated excellent long-term survivability, although they may be subject to limited marginal bone loss. Marginal bone loss during the first few years after implant placement seldom represents disease, but is instead the result of an adaptive bone response to surgical trauma and implant loading. It is not uncommon for implants with early marginal bone loss to enter a long-lasting state of bone stability. Extensive bone resorption after the first year is generally due to an exacerbation of adverse body reactions caused by non-optimal implant components, adverse surgery or prosthodontics and/or compromised patient factors. Disease in the form of peri-implantitis is a late complication that affects some implants with suppuration and rapid loss of crestal bone, and is probably caused by bacterial pathogens and immunological reactions. Unfortunately, the literature is not consistent with respect to the type or magnitude of clinical implant problems, including how they are defined and diagnosed. If the peri-implantitis diagnosis is confined to cases with infection, suppuration and significant bone loss, the frequency of the disease is relatively low, which is in sharp contrast to the frequencies reported with unrealistic definitions of peri-implantitis. We suggest that when modern implants are placed by properly trained individuals, only 1-2% of implants show true peri-implantitis during follow-up periods of 10 years or more. Peri-implantitis must be separated from the initial and self-limiting marginal bone loss.

Survival of NobelDirect implants: an analysis of 550 consecutively placed implants at 18 different clinical centers.

BACKGROUND: A recently introduced implant, the NobelDirect (Nobel Biocare AB, Göteborg, Sweden), has previously been documented with substantial bone resorption in a large number of operated cases. PURPOSE: The aim of this study was to evaluate the failure rate of NobelDirect implants in a retrospective multicenter survey. MATERIALS AND METHODS: A total of 550 NobelDirect implants consecutively placed in over 269 patients at 18 centers were evaluated with regard to failure rate after an average follow-up of about 1 year. RESULTS: The overall failure percentage was 10.9% (59 failures). The 58 implants not loaded directly showed only one failure (1.7%) versus 58 failures (11.8%) of those implants that were loaded directly. A chemical x-ray photoelectron spectroscopy analysis of an implant from the original batch showed up to 3.5% silicon at parts of the implants. A retrieval analysis of one implant removed at 2 years after placement demonstrated bone resorption down to the level of the fifth thread. CONCLUSIONS: It is concluded that the NobelDirect implant, if placed with a punch procedure, ground down in situ, and loaded directly, shows an unusually high failure rate at 1 year.

Direct loading of Nobel Direct and Nobel Perfect one-piece implants: a 1-year prospective clinical and radiographic study.

OBJECTIVES: The aim of this prospective study was to evaluate the Nobel Direct and Nobel Perfect one-piece implants (OPIs) when used for immediate function. MATERIAL AND METHODS: Forty-eight patients were provided with 115 OPIs for loading with a provisional crown or a bridge within 24 h and followed for at least 12 months with clinical and radiographic examinations. A group of 97 patients previously treated under identical conditions by the same team with 380 two-piece implants (TPIs) for immediate loading in the mandible and maxilla served as the reference group. RESULTS: Six (5.2%) OPIs failed during the follow-up due to extensive bone loss. Five (1.3%) implants failed in the reference group. After 1 year, the mean marginal bone loss was 2.1 mm (SD 1.3) for OPIs and 0.8 mm (SD 1) for TPIs. 20% of OPIs showed more than 3 mm of bone loss compared with 0.6% for TPIs. When compensating for vertical placement depth, OPIs still showed a lower marginal bone level and thus more exposed threads than TPIs. Depending on the criteria used, the success rate for OPIs was 46.1% or 72.2% compared with 85% or 91.6% for TPIs. CONCLUSIONS: The Nobel Direct and Nobel Perfect OPIs show lower success rates and more bone resorption than TPIs after 1 year in function. Factors such as implant design, insertion depth, rough surface towards the mucosa, in situ preparation and immediate loading may have an influence on the clinical outcome.