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
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.
