Results from two of the largest
international clinical studies performed to date with dental implants have just
been published and demonstrate excellent clinical performance. Together, the
studies have evaluated more than one thousand Straumann Bone Level implants in
Europe, the US and Australia. The scope of these studies is particularly
remarkable in view of the fact that most dental implant companies do not
conduct clinical trials because they want to cut costs and do not have the
capabilities.
The studies are also remarkable in that they
both reported very high implant survival rates of more than 98% with
practically no bone loss around the implants. The findings are considerably
better than values reported in a comprehensive review of previously published
studies with other implants[1]. The new studies add to the wealth of strong
clinical evidence backing the Straumann dental implant system and thus provide
very good reasons for patients and dentists to insist on Straumann implants
rather than undocumented alternatives.
The
benchmark in clinical research
The first study was a randomized
controlled clinical trial (RCT) at 11 clinical centers in Europe, USA and
Australia[2]. RCTs are the benchmark in clinical research because they offer
the highest level of clinical evidence. However, few are performed with dental
implants and very rarely on such a large scale.
This RCT has evaluated 106 patients each
treated with one implant and followed for three years. The investigators
compared the outcomes of two different approaches - the first involving two
surgical steps, in which the implant is covered with gum tissue ('submerged')
during healing, and the second involving just a single step, in which part of
the implant is left exposed ('transmucosal') thus saving a second surgical
operation. The most impressive highlight reported was the fact that only a
single implant was lost, yielding 3-year implant-survival rates of 98.1% and
100% for the transmucosal and submerged groups respectively.
Because bone loss around implants has been
documented as a common undesirable effect of implant treatment[3], this study
looked carefully at bone level changes. It showed that bone level was
impressively stable over 3 years after implant placement, with mean decreases
of less than 0.7 mm and 0.6 mm in the submerged and transmucosal groups
respectively. These values are well below the data presented in previous
studies with other implants. An analysis of published data showed that only
three implant systems achieved mean marginal bone loss below 1 mm over a period
of 5 years[1].
Excellent
results also achieved in everyday practice
While RCTs demonstrate that products
or treatments work well, they are usually conducted by specialists in selected
and strictly controlled populations. This study was performed by dental
practices and University clinics that are highly specialized in dental
implantology, which raises the question of whether its excellent results can be
reproduced in daily dental practice. To answer this, a large study using the
same implant was conducted in Europe and the US, in which the dentists had to
follow the product guidelines but were able to use the implant as they would in
normal daily practice. The strength of this type of investigation, which is
known as 'non-interventional study' (NIS), is that it documents real-life
situations, in which indications, patients and conditions all vary widely.
In this study[4], a total of 908 implants were
evaluated in 538 patients at more than a hundred dental practices in six
countries, revealing an implant survival rate of 98.5% after one year (the risk
of failure is highest in the first year after implant placement5). Besides the
very high survival rates, the bone level remained very stable in the majority
of cases. The investigators therefore concluded that treatment with Straumann
Bone Level Implants yielded very successful outcomes in 'real life' conditions.
Results impress further when viewed in the context of
other published data
The survival rates
reported in both studies are higher than those documented in the literature.
The most recent analysis of published data on other implants showed an overall
implant survival rate of 95.5% one year after implant placement[5], in contrast
to the 98.5% achieved in this NIS in daily dental practice conditions.
Medicalnewstoday.com
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