A Critical Analysis of Nobel

Biocare's new NobelActiveTM

Implant and CurvyTM Abutment

Nobel Biocare (Nobel) launched a new

implant and abutment at its Las Vegas
Symposium, May 21-24, 2007. The controver-
sies over the research and clinical success
of the NobelPerfect and NobelDirect
Implants in four Merrill Lynch Reports1-4
prompted this analysis of the design, surgi-
cal procedures and clinical efficacy of
Nobels new products. Clinical pictures
shown in this analysis were taken from a VT
posted on Nobels website showing the
insertion of the NobelActive Implant during
its 2007 Las Vegas Symposium.
Jerry Niznick DMD, MSD
President, Implant Direct

CURVYTM ABUTMENT:
This abutment for Nobels implants with the
internal tri-lobe connections, is designed
with a deep groove between the implant
junction and the contoured pre-machined
margin. From my calculations, the contoured
margin of the Curvy abutment is about 3mm
above the top of the implant, compromising
its use in the esthetic zone. The groove
designed to simulate platform switching, a
questionable concept in any case, creates
an undercut below the contoured margin on
the titanium abutment, preventing a more
apical positioning of the margin of the final
restoration. If the tissue thickness is greater
than 3mm, the margin of the restoration may
be placed sub-gingival, but if it recedes,
preparing the margin on the abutment in a
more apical position would be difficult if not
impossible because of the undercut created
by the platform shifting groove.

NOBELACTIVETM IMPLANT:
The NobelActive implant design, with its straight
outside thread diameter and Tapered inside
thread diameter, is very similar to the design of
the Pitt-Easy implant sold by the German
Oraltronics Company since 1987 (now owned
by Innova), and also appears to be a copy of
the Israeli Alpha Bio company founded by Dr.
Ophir Fromovich, the same dentist who per-
formed the surgical demonstration of the
NobelActive implant at the 2007 Symposium.
This design is not conducive for insertion in
dense bone without use of a bone-tap so it is
not self-drilling as claimed by Nobel.
(NobelActiveTM & CurvyTM are trademarks
of NobelBiocare Inc.)
Nobel's marketing claim is that this implant is
self-drilling indicating that it is intended for
soft bone (Type 3 & 4). The correct term would
be self-threading and is achievable with any
screw implant in soft bone. The surgical proce-
dure used by Dr. Fromovich for placing 4
NobelActive implants into sockets immediately
following extraction of maxillary anterior, peri-
odontally compromised teeth, included drilling
the implant sites and inserting the implants at
a 45 degree angle to the lingual, and then tip-
ping the implants upright for parallelism. Nobel
claims on its website that the NobelActive
implant provides high initial stability and good
outcomes. They fail to define what is meant
by good outcomes. No flap was reflected to
examine the extend of bone loss following
removal of the four loose, infected teeth, and
therefore no site preparation such as grafting
or guided tissue regeneration was done to
minimize subsequent bone loss or soft tissue
recession. Some synthetic bone chips were
packed into the sulcus surrounding the
implants and either ended up in the bony
defect or just in the soft tissue sulcus. The
effect of this type of blind grafting is question-
able. The design of the implant itself in con-
junction with the surgical procedure followed
by Dr. Fromovich, does not contribute to the
high initial stability claimed by Nobel. In type
3 and 4 bone, where increasing initial stability
is highly desirable, the crestal bone is denser
where the NobelActive implant lacks threads.
The trabecular bone in the apical region of the
implant is usually very porous, so threads in
the apical region of the NobelActive implant
would present a low percentage of contact.
Initial stability is a critical issue in achieving
osseointegration, especially where immediate
provisional loading is desired as in this case.
The surgical demonstration by Dr. Fromovich
shows four NobelActive implants immediately
splinted together with a cross-arch temporary
restoration. There is no indication by Nobel or
Dr. Fromovich, whether this implant is indicat-
ed for single tooth replacement with immediate
temporization. Twisting the implants upright to
parallel the heads allowed fabrication of the
temporary restoration but is contrary to accept-
ed surgical principals followed to avoid bone
compression, fracture and loss of initial stabili-
ty. Tipping an implant to the lingual would have
the effect of leaving a void on one side while
crushing bone on the side to which the implant
was displaced. It is hardly conducive to opti-
mal initial stability or preservation of remaining
bone. Achieving osseointegration without
splinting these four implants is open to specu-
lation, as is the degree of bone loss and tissue
recession. No Post-Op Xrays were presented.
Nobel Biocare has provided no bench tests,
clinical data or even design logic to justify the
use of the NobelActive implant in areas of soft
bone, narrow ridges or immediate load. In fact,
the surgical protocol, body shape and thread
design of this implant will neither compress soft
bone nor facilitate expansion of a narrow ridge
as can be accomplished by inserting a tapered
implant into an undersized socket. Implant
Directs Spectra-SystemTM implants, including
the one-piece ScrewDirectTM and two-stage
RePlusTM implants, are evenly tapered with the
same thread depth maintained over the entire
length. In soft bone, the surgical protocol spec-
ifies insertion into an undersized socket, pre-
pared with a straight drill, facilitating both bone
expand in narrow ridges and bone compaction
for increased stability. An article by 5Niznick
documented increased initial stability inserting
a tapered implant into an undersized socket
prepared with a straight drill, and 6.Shalabi
demonstrated that such a procedure also
resulted in increased removal torque and bone
contact after osseointegration.

IMPLANT DIRECT'S REPLUS IMPLANT:

The body design of this Tri-lobe, prosthetically
compatible implant includes the same even
taper developed in 1998 for the Tapered Screw-
VentTM (now sold by Zimmer Dental) and
improved upon in 2006 by Implant Direct LLC
with the addition of mini-threads, a longer verti-
cal cutting groove and with the SBM surface
extended to the top. The RePlus provides
increased strength compared to Nobels
Replace implant because it uses the stronger
titanium alloy material and its wider diameters
provide thicker walls with a platform switching
transition between the implant and the abut-
ment. The Curvy Abutment with a groove in the
abutment and the NobelActive with a few
grooves in the neck of the implant, try to simu-
late the effect of platform switching to capitalize
on the marketing benefits of this feature pro-
moted by 3i, Astra and Ankylos. While the ben-
efits of platform switching are controversial,
these two new Nobel products clearly miss the
mark of providing thicker tissue at the implant
abutment junction.

Based on the surgery performed by Dr.

Fromovich using the 4 Nobel Active implants, at
the Nobel Symposium, it appears that the sur-
gery procedures were driven by the limitations
of the implant design itself. The one-stage
implant has a straight head with an external
square for insertion. A straight abutment is then
tapped on to this projection, rather than being
screw-retained. The ScrewDirect 1-Piece
implant with a straight head or the ReDirect
1-Piece implant with a 12 degree angled head,
both with pre-machined margins, would be bet-
ter choices both from a prosthetical and surgi-
cal standpoint. Based on the esthetic demands
of this case, and the amount of bone loss from
periodontal disease, a two piece implant, like
the ScrewPlant or RePlus, could not be dis-
counted as the treatment of choice, without
immediate loading to allow for optimum bone
site healing following possible site preparation
with bone grafts. The NobelActive 1-stage
implants having external squares atop a long
tapered neck for insertion and are designed for
attachment of friction fit straight abutments.
Manipulating soft bone by up-righting the
implants, as done in this case, could potentially
result in a facture of the labial or lingual plate
ov bone, which would not be easily detected
since no flap was reflected. While these four
implants so manipulated during surgery, may
still achieve osseointegration, primarily
because of the immediate cross-arch splinting,
such a procedure would most likely result in a
failure if any of these implants were restored
free-standing. The NobelActive implant will
undoubtedly come under extreme scrutiny by
those experienced with proper surgical proce-
dures and those who are critical of the sale of
radically different dental implant designs with-
out proper research. After the controversies
related to bone loss associated with the
NobelDirect and NobelPerfect implants, even
the most enthusiastic Nobel advocate will
question reliance alone on Nobels claims of
good outcomes without well documented clin-
ical studies substantiating these claims.

A former Nobel Biocare System educator said

it best after seeing the NobelActive and Curvy
Abutment - The spirit of research, established
by the Branemark Team in Gothenburg is
dead. It promises to be interesting to see how
Nobel Biocare will justify its premium prices of
approximately $500-$850 for an implant and
abutment, when Dr. Fromovich/Alpha Bio of
Israel, the developer of the NobelActive
implant, traditionally sells his implants for $50-
$100 in Israel and in Eastern Europe.
References: All Available on www.implant direct.com
1. ML Report 4/6/2006: USC Study Now (critical of
NobelPerfect bone loss).
2. ML Report 7/19/2006: NobelDirect Expert Panel Issues
Critical Report.
3. ML Report 9/15/2006: Expert Panel Indicates
NobelDirect Withdrawal.
4. ML Report 2/19/2007: Study shows higher complications
with Nobel Guide.
5. Achieving Increased Success in Soft Bone:G.. Niznick
Oral Health 8/2000.
6. Shalabi et al. Effects of Implant Surface Roughness
COIR. Vol. 17, #2 4/06