Purpose: The present retrospective clinical study was undertaken to evaluate the survival rate and marginal bone conditions around Nobel Direct one-piece implants. The purpose was also to compare the results with when these implants are used for immediate/early loading with implants allowed to heal before loading.
Material and methods: Forty-three consecutive patients previously treated with 117 Nobel Direct implants at four different centres were evaluated. The implants had been used in both jaws for treatment after loss of single and multiple teeth. Immediate/early loading (within 2 weeks) with a provisional crown/bridge was applied to 95 implants, while 22 implants healed unloaded for 6 weeks to 6 months before loading. Calculations of marginal bone loss were performed in radiographs taken at placement and after an average of 10.2 months (range 1–18 months) of loading.
Results: Six (5.1%) of the 117 implants were removed during the follow up. All failed implants belonged to the immediate/early loading group giving a failure rate of 6.3% for this group and 0% for two-stage implants. The failure rate was higher for flapless (7.9%) than for flap surgery (0%). The marginal bone loss was ?2.4 mm (SD 1.5) for all implants, while 37.6% showed more than 3 mm of loss during the follow up. Bone loss increased with time of follow up. Implants subjected to immediate/early loading showed more bone loss than two-stage implants: ?2.6 mm (SD 1.5) vs. ?1.6 mm (SD 1.1). Moreover, 41.3% of immediately loaded and 22.7% of two-stage implants presented with more than 3 mm of bone loss.
Conclusions: This short-term retrospective analysis showed a poor clinical outcome of Nobel Direct implants. Extensive marginal bone loss (>3 mm) was found around more than 1/3 of the implants evaluated. Less resorption and no failures were experienced when implants were allowed to heal from 6 weeks to 6 months before occlusal loading. Within the limitations of the present study design, data indicate that immediate loading, the use of this implant for multi-unit constructions and flapless surgery are risk factors for failure of Nobel Direct implants.
Short-term clinical results of Nobel Direct implants: a retrospective multicentre analysis. Read more: http://www3.interscience.wiley.com/journal/119407003/abstract?CRETRY=1&SRETRY=0
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.
Survival of NobelDirect implants: an analysis of 550 consecutively placed implants at 18 different clinical centers. Read more: http://www.ncbi.nlm.nih.gov/pubmed/17535329
The Medical Products Agency (MPA) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drugs and other medicinal products. Their task is to ensure that both the individual patient and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner.
Here is an excerpt from a letter that the MPA sent to Nobel Biocare on 12/6/2006.
As shown, the percentage shares with marginal bone resorption >3 mm throughout are double-digits for NobelDirect and NobelPerfect, that compared with 1% for Brånemark System inT-091. CSR in T-106, fulfils the high demands, while the 92.8% in Sennerby’s report should be seen to lie at the lower limit for the expected. Recently, Nobel Biocare supplemented T-106 A+0B with results from the 2-year follow-up. This includes 62 implants whereof none from Clinic 4. The share of implants with marginal bone resorption >3 mm now amounts to 8% and CSR to 98%, which must be considered to point to that bone resorption in this group at least did not progress during the second year. However, the MPA’s position is that this 2-year data in spite of everything does not eliminate the view that NobelDirect and NobelPerfect in these treatment series are associated with early appearance of raised marginal bone resorption unexpectedly often.
Read more: http://nobeldirect-litigation.com/wp-content/uploads/2010/07/061206-Nobel-Biocare-Beslut-EN.pdf
If you are a dentist, and you have implanted any NobelDirect device, and you have had to subsequently remove the device, or have had other problems with the device, you are urged to immediately contact class counsel to protect your rights. You may call us toll-free at 877.775.6337 to speak to an attorney, or you may fill out the simple form on the right side of this page.
Nobel Biocare is a company operating in dental implantology and aesthetic dental solutions. The headquarters are located in Kloten near Zurich, Switzerland. The company was founded as Nobelpharma in 1981 and renamed Nobel Biocare in 1996.
The firm concentrates on the development, production and marketing of dental implants, crowns and bridges as well as veneers and laminates as dental prostheses. Nobel Biocare has four production centers in Sweden and the USA and its own sales organizations in 33 countries.
[From Wiki]
The NobelDirect implant was launched in 2004. It was claimed by Nobel to be simple to use by nonspecialist dentists and to result in essentially no incidence of “bone re-absorption.” The implant is recommended by Nobel Biocare for placement without the need for a surgical flap, followed by immediate “loading” of the implant.
However, according to allegations in a recently filed lawsuit, the long, narrow, non-linear tapered design of the implant leads to an excessively high about of marginal bone loss surrounding the implant. This allegedly occurs as a result of the defective design of the implant, and is not a result of dentist-specific causes.
In fact, one study concluded that after approximately one year, over 10 percent of NobelDirect implants placed had already completely failed (i.e., they had to be entirely removed from the patient’s jaw.)
Another allegation in the complaint is that Nobel Biocare “knowingly and intentionally” marketed these devices to general dentists, knowing that the allegedly defective devices would soon have to be removed.
According to the filed lawsuit, this has caused innumerable problems for dentists who purchased and implanted these implants for their patients. These dentists now face a flood of complaints from injured patients. As a result of this allegedly defective design and marketing on the part of Nobel Biocare / NobelDirect, both the dentists and their patients have been harmed by these devices.
If you are a dentist, and you have implanted any NobelDirect device, and you have had to subsequently remove the device, or have had other problems with the device, you are urged to immediately contact class counsel to protect your rights. You may call us toll-free at 877.775.6337 to speak to an attorney, or you may fill out the simple form on the right side of this page.
Three years after patients were given Nobel Direct dental implants, the risk of the implant loosening has increased even more. A follow-up by researchers at the Sahlgrenska Academy in Sweden shows that eight per cent of the implants are lost.
Read more: http://www.medicalnewstoday.com/articles/92555.php
This is the NobelDirect Clinical Manual. 
The NobelDirect implant was launched in 2004. It was claimed by Nobel to be simple to use by nonspecialist dentists and to result in essentially no incidence of “bone re-absorption.” The implant is recommended by Nobel Biocare for placement without the need for a surgical flap, followed by immediate “loading” of the implant.
However, according to allegations in a recently filed lawsuit, the long, narrow, non-linear tapered design of the implant leads to an excessively high about of marginal bone loss surrounding the implant.
Other legal allegations in the complaint include defective marketing and design of the NobelDirect implants. According to the complaint, this has caused harm to numerous patients, and the dentists who have had to deal with the injuries caused by these allegedly defective medical devices.
The NobelDirect implant was launched in 2004. It was claimed by Nobel to be simple to use by nonspecialist dentists and to result in essentially no incidence of “bone re-absorption.” The implant is recommended by Nobel Biocare for placement without the need for a surgical flap, followed by immediate “loading” of the implant.
However, according to allegations in a recently filed lawsuit, the long, narrow, non-linear tapered design of the implant leads to an excessively high about of marginal bone loss surrounding the implant.
Other legal allegations in the complaint include defective marketing and design of the NobelDirect implants. According to the complaint, this has caused harm to numerous patients, and the dentists who have had to deal with the injuries caused by these allegedly defective medical devices.
