COMMENTS FROM ITI USER TO TAPERED SWISSPLUS IMPLANTS

The design looks ingenious...incorporated a lot of advantages of other designs
and added a few of your own twists (no pun intended). Can you provide
information about materials, tolerances, surface, fatigue, etc?

ANSWERS:

1. Material: Work-hardened Grade 4 CP Ti with a Tensile strength of 132. When you consider that Alloy has a minimum tensile strength requirement of only 120, this is very strong for still being 99.5% Ti. I think that ITI uses something very similar.

2. Tolerances: Paragon filed for a new 510k application on the SwissPlus and Tapered SwissPlus System, along with extensive documentation confirming its claims of complete interchangability between the SwissPlus and ITI synOcta 4.8mmD internal octagon implant platforms. Our documentation has been cleared by the FDA for system compatibility which means that we manufacture to the same dimensions and within the same tolerances as ITI's parts demonstrate. Furthermore, Paragon documented surgical compatibility with its Straight SwissPlus and the ITI system implants. There are close-up pictures on the SwissPlus Technology section of our web site that demonstrate the interchangability between the systems, the increased precision of the SwissPlus Cover Screw fit (because ITI implants have a flat ledge where the fluted surface meets the shoulder) and the more uniform transition line between the smooth and the blasted surfaces of our implants.

3. Surface: SBM which stands for soluble blast media. We blast the implant with tricalcium phosphate which is soluble so we do not need to do an acid wash like SLA to remove impregnated Aluminous Oxide particles. The result is about the same degree of medium roughness without rounding the threads (check out the histology, test results and close-up SEMs on the straumann-clone web site.) Three independent university studies demonstrated a higher degree of bone contact with our SBM than with TPS (one study used ITI's TPS coated implants). Two of the studies even showed a higher percentage of contact with SBM vs HS, although this says nothing about the difference in attachment strength which could be higher for HA as measured by torque. One of these studies (LSU -- Dr. Isreal Finger's grad student) did compare torque removal and I don't recall if the difference was significant.

4. Fatigue Strength: The idea behind making the design of the small diameter implant tapered was to increase its strength as compared to the narrow ITI implants which are not recommend for use as a single tooth replacement other than for laterals, or their 3.3mmD implant for single tooth replacements. We were able increase the strength of the narrow Tapered SwissPlus by about 100lbs at 30 degrees of compression (ITI = 287lbs, SwissPlus = 383lbs to 397lbs). The narrow Tapered SwissPlus Implants with the narrow (3.8mmD) internal hex platform and the synOcta 4.8mmD internal octagon platform have the same body dimensions but the narrow platform implant has slightly higher compression strength (397lbs). Even more important than metal fatigue of this narrow diameter platform implant is the fact that it has an outer bevel. Abutments that fit over the outer bevel will add to the strength of both the connection and support the strength of the implant.

Other Significant Advantages of the Tapered SwissPlus:

1. SURFACE AREA AND THREAD ENgageMENT: The 4.8mmD Tapered SwissPlus offers a 17% increase in surface area and a 34% increase in initial thread engagement, compared to the 4.8mmD ITI implant.

2. PROSTHETIC VERSATILITY: Full-contour preparable abutments allow preparation of the margins to follow the contours of the soft tissue, thus eliminating the deep pockets created by extending the margin subgingival to the implant shoulder as required with the solid abutments of the ITI system (often these can be 4mm on the lingual in the maxilla just to get the margin subgingival on the labial). Preparable margins that follow the tissue contour facilitate conventional impression procedures.

3. PROSTHETIC SAVINGS: Paragon also offers one- and two-piece narrow abutments with the implant shoulder exposed. The one-piece solid abutment, which includes a plastic castable sleeve, is priced at $59, which represents half the price of the ITI solid abutment and plastic castable sleeve. Furthermore, the SwissPlus plastic sleeve is designed for use as a Transfer, saving an additional $10. It is retained on the narrow abutment by a retentive plug that eliminates the need for the snap-on design used by ITI. ITI’s plastic sleeve has an extension that engages the undercut just below the shoulder of the ITI solid abutment analog. Once cast in gold, this extension requires removal by rotary stones, adding to the marginal inaccuracy.

4. COST SAVINGS: With the Fixture Mount serving as the Transfer and a straight preparable abutment, and a 2mm high Cover Screw provided free with the Tapered SwissPlus, the Surgeons who provide abutments and Transfers to restorative dentists will save at least $132 with the 4.8mmD implants and significantly more when compared to the $275 cost of the ITI narrow-neck implant. More importantly, the Tapered SwissPlus Narrow Neck implant is far stronger and more prosthetically friendly than the expensive ITI Narrow Neck implant with a 1.6mm high external octagon projection.

Paragon’s Straight SwissPlus, which more closely resembles the ITI design threads, but with a self-tapping, tapered apex, is priced at $180 including the Fixture Mount/Transfer/Abutment and Cover Screw. While the Straight SwissPlus is an improvement over the ITI implant at substantially less cost, the new Tapered SwissPlus offers compelling reasons for ITI users to change, including increased thread engagement and surface area, a soft-bone surgical protocol by placing the tapered implant into a socket prepared with the straight intermediate drill, and a strong small diameter implant.

DESIGN ADVANTAGES OF TAPERED SWISSPLUS IMPLANTS

1. Threads over entire surface (unlike threaded Friadent) and threads that are deeper near the top for increased initial stability and load carrying capability -- both essential factors in earlier loading. Double lead threads allow as fast an insertion as with the Friadent implant with its fewer threads.

2. Two-millimeter-long fluted neck (compared to 2.5mm for SwissPlus) for true one-stage healing (compared to Steri-Oss and Friadent that need healing collar). Extra neck length will accommodate for different bone heights from buccal to lingual in extraction sockets, for one or two-stage procedures.

3. Beveled shoulder for more lateral stability than flat shoulder.

4. Tapered design inserted into socket prepared with straight drill (with apical 3mm having reduced diameter) rather than Friadent's step implant design with matching step drill. This allows for a different surgical protocol for soft or hard bone. In soft bone, use intermediate drill (3.8mmD for 4.8mmD implant) as final sizing of socket for bone compression/expansion and full engagement of deep threads. In dense bone, final sizing drill with apical step (4.3mmD/3.8mmD) allows easy self-tapping insertion with apical thread engagement.

5. Packaged on Fixture Mount that is designed as Transfer but with full-contour to serve as straight Preparable Abutment.


Compare 4.8mmD Tapered SwissPlus to 4.8mmD ITI

Straumann 4.8mm implant = $240 + $40 for 2mm Cover Screw + $20 for 2-piece Transfer + $98 for narrow, solid abutment + $20 for Plastic Castable Sleeve for Solid Abutment = $418 SwissPlus Straight implants = $180 including 2mm Cover Screw, and 2-piece Transfer that is full-contour Preparable Abutment (Savings = $238)

1. Tapered for anatomical limitations of bone -- ITI and SwissPlus clone are straight.

2. More threads (0.9mm pitch vs 1.2 mm pitch) and deeper threads near the top, for increased initial stability and load carrying capability -- both essential factors in earlier loading. 17% increase in surface overall with 34% increase in thread engagement surface. Double lead threads allow faster insertion and apical cutting groove allows self-tapping insertion.

3. Narrow diameter implant (tapers from 3.7mm to 3.0mm) with ITI compatible platform is stronger than 3.3mmD narrow implant from ITI (not recommended for single tooth use in Straumann catalog).

4. Narrow diameter implant (tapers from 3.7mm to 3.0mm) with internal hex platform ($235) and external beveled shoulder, more closely matches the ITI concept than the Narrow Neck ITI implant ($275) with its long external hex. Flat top will provide improved esthetics due to the ease of making low profile angled abutments.

5. Tapered design inserted into socket prepared with straight drill (with apical 3mm having reduced diameter) rather than Friadent's step implant design with matching step drill. This allows for a different surgical protocol for soft or hard bone. In soft bone, use intermediate drill (2.8mmD for 3.7mmD implant or 3.8mmD for 4.8mmD implant) as final sizing of socket for bone compression/expansion and full engagement of deep threads. In dense bone, final sizing drill with apical step (3.4mmD/2.8mmD for 3.7mmD implant or 4.3mmD/3.8mmD for 4.8mmD implant) allows easy self-tapping insertion with apical thread engagement.

6. Packaged on Fixture Mount that is designed as Transfer but with full-contour to serve as straight Preparable Abutment.

7. Variable height Healing Collar packaged with implant (Implant Extender + Cover Screw) Compare Straumann Small Diameter Implants to Tapered SwissPlus

Compare Straumann Small Diameter Implants to Tapered SwissPlus

COMPARE SwissPlus PRICES with ITI System (all prices are U.S. List Price) Straight SwissPlus implants in 4.1mmD and 4.8mmD = $180 Tapered SwissPlus implants in 3.7mmD with Internal Hex (narrow neck) or synOcta Platform (4.8mmD Internal Octagon) = $235 and include: 2mm Cover Screw and Fixture Mount that is Transfer and Preparable Abutment.

ITI Implants vary in price based on diameter and do not include Cover Screw ($30 for 1mm, $40 for 2 - 5mm) Implants with 4.8mm Internal Octagon Platform 4.8mmD Platform 3.3mmD = $230; 4.1mmD = $220; 4.8mmD = $240 6mmD Platform - 4.8mmD implant = $265

ITI 6mmD Wide Platform Implant is not needed with SwissPlus full-contour abutments that cover shoulder because Emergence Profile can be achieved in the abutment. The 4.1mmD SwissPlus comes mounted on a 5.2mmD Fixture Mount with a matching diameter cover screw. The 4.8mmD SwissPlus comes mounted on a 6.0mmD Fixture Mount with a matching diameter Cover Screw.

Additional prosthetic items needed with ITI System that are not with SwissPlus include ITI one-piece Solid Abutment - $98 + $20 plastic coping = $118 (soon available from Paragon for $48 including plastic coping.)

Straumann’s Implant with Octa Abutment Top

4.1mmD Implant with Octa Abutment Top = $290
This implant design is not needed with SwissPlus because of the availability of plastic and gold copings that connect directly to implant platform for splinting implants with screw-retained bars and fixed-detachable prosthesis.

Compare SwissPlus Narrow Implant to ITI Narrow Neck Implant PRICE of ITI 3.3mmD Implant/3.5mmD platform and 1.6mm External Octagon Implant = $275 + Cover Screw @ $42 + Direct Transfer @ $35 + Titanium Abutment @ $67 = $419

NEGATIVE FEATURES:

1. Straumann’s Published Contraindication: “Cannot be used when particularly high loads can be expected such as bruxism, posterior placement and frames with distal extension.” (Straumann advises against using their 3.3mmD implant with the 4.8mmD platform for single tooth replacements and only recommends this narrow neck 3.3mmD implant for single tooth replacement of laterals. By contrast, SwissPlus 3.7mmD Tapered SwissPlus is as strong as 4.1mmD implant at neck.

2. Tall External Octagon complicates angle corrections -- no angled abutments sold in the U.S. market. For angled abutments, the only option is to fabricate a custom cast abutment on a $130 gold coping.

TAPERED SWISSPLUS WITH NARROW PLATFORM

PRICE = $235 including 2mm Healing Collar, Transfer and Preparable Abutment
Cost Savings with Narrow Neck Tapered SwissPlus vs Narrow ITI: $419 - 235 = $185
Straight SwissPlus vs Straumann 4.8mmD implants - 4.8mmD Platform

COST: SwissPlus = $180 including 2mm HC, Transfer and Abutment
COST: Straumann = $240 + 2mm Cover Screw @ $40 + Solid Abutment @ $98 + Castable Sleeve @ 20 + Transfer Component @ $20 = $428
SAVINGS PER TOOTH: $428 - $180 = $248

NARROW (3.7mmD) SWISSPLUS VS 3.3mmD ITI -- both with 4.8mmD Platform
COST: SwissPlus = $235 including 2mm HC, Transfer and Abutment
COST: Straumann’s 3.3mmD implant with 4.8mm Platform with or without Internal Octagon = $230 + 2mm Cover Screw @ $40 + Solid Abutment @ $98 + Castable Sleeve @20 + Transfer Component @ $20 = $408
SAVINGS PER TOOTH: $408 - 235 = $173

SwissPlus ADVANTAGES:

1. Internal hex (vs 1.6mm external octagon) reduce vertical height, allowing more esthetic restorations where angled abutments are needed.

2. Internal hex with external bevel provides more stable platform than external octagon with narrow shoulder.

3. Implant dimensions of 3.7mmD at top tapering down to 3.0mm at apex provides same strength as standard 4.1mmD ITI implant.

4. Self-tapping insertion facilitated by apical cutting grooves, sharper threads and and additional apical thread. Thread definition is maintained with SBM blasting with a soluble material, compared to blasting with Aluminum Oxide followed by acid etching (SLA surface) to remove blast particles with Straumann’s implants.

5. Double lead threads provide faster insertion.

6. Thread surface is increased because threads of SwissPlus are 0.9mm apart instead of 1.2mm apart with ITI implants.

7. Tapered design increases initial stability in soft bone by allowing insertion into socket prepared only to size of intermediate drill with progressive taper expanding and compressing the soft bone.

Compare Tapered SwissPlus to Friadent and Steri-Oss Replace Select

TAPERED SWISSPLUS vs FRIADENT IMPLANT

PRICE of Friadent Implants: $255 including Cover Screw
Straight Abutment = $99, Angled Abutment = $130; Transfer= $50; Healing Collar= $32. The Fxture Mount is not designed to be a Transfer or Abutment.
TOTAL COST FOR SINGLE TOOTH REPLACEMENT:
Using Straight Abutment and Healing Collar for one-stage healing = $436
SAVINGS PER TOOTH: $436 - 235 = $201

NEGATIVE FEATURES of Friadent Externally Threaded Implant:

1. Not a one-stage implant

2. Threads do not cover entire body and there are no apical threads

3. All the preparable abutments have shoulders and the shoulder on the angled abutment is higher on the labial than the lingual

4. Fixture-mount is not multi-functional

5. Shoulder butt joint vs reverse bevel joint of SwissPlus

6. Different drill required for each length and diameter implant

TAPERED SWISSPLUS vs STERI-OSS REPLACE SELECT:

PRICE: Replace Select (Internal 3 channels = $269 including Cover Screw);
The Fixture Mount is not designed to be a Transfer or Abutment.;
Straight Abutments = $103;
Angled Abutment = $157; Transfer = $41;
Healing Collar = $40
TOTAL COST FOR SINGLE TOOTH REPLACEMENT:
Using Straight Abutment and Healing Collar for one-stage healing = $452
SAVINGS PER TOOTH: $452 - $235 = $217

NEGATIVE FEATURES of Steri-Oss Replace Internal Channel Implants:

1. Need different drill for each implant length and diameter plus a different bone-tap for each implant diameter (16 final sizing instruments vs 3 for Tapered SwissPlus)

2. Not a one-stage implant

3. Substantially less surface area than Tapered SwissPlus Threads (Replace’s threads are shallow with upside-down design)

4. Not self-tapping (no apical threads, no self-tapping vertical cutting grooves)

5. Not available with blasted surface (smooth acid-etch, HA or TPS)

6. Fixture Mount is not multi-functional

7. Shoulder butt joint vs reverse bevel joint of SwissPlus


IMPLANT
TYPE
IMPLANT
COST
HEALING
COLLAR
TRANSFER
STRAIGHT
ABUTMENT
TOTAL
PER UNIT
4.8 Straight
SwissPlus
$180 SBM
Blast
2mm
Included
Included
Included
$180
4.8 Tapered
SwissPlus
$240 SMM
Blast
1mm-3mm
Included
Included
Included
$240
4.7 Tapered
Screw-Vent
$235 SBM
$240 HA
$30
Included +
Temp. Abut.
$90
$355
4.8mmD ITI
Straumann
$240 SLA
Blast/Etch
$40
$20
Plastic Sleeve
$98 + $20
$428
4.5mmD
Friadent
$255
Blast & TPS
$32
$50
$99
$436
5mmD Select
Steri-Oss
$269
HA TPS
$40
$41
$103
$452
5mmD 3i
Ext. Hex
$255
Acid Etch
$49 2-piece
$43 1-piece
$42
for Ti Screw
$98 + $36
$480
4.7 Taper-Lock
Ext. Hex
$125 SBM
$135 HA
$30
Included +
Temp. Abut.
$55
$210


RESTORATIVE COSTS WITH 3I SYSTEM

• Transfer Component = $42

• Straight Abutment = $98 + Gold Screw $46 (fixation screw not included) - You can use 3i’s titanium screw for $36, but they recommend the gold screw to hold parts together. Clamping forces are critical with an external hex connection because the screw takes the lateral load (except Paragon's External Hex implants with friction-fit connections -- guaranteed for 5 years against screw loosening).

• Prep-Tite Healing Cap = $12. This is needed because the abutments pre-machined margin cannot hold back the tissue without this part.

Cost of 3i's STA Single Tooth Abutment is $188 plus $70 for gold cylinder =
$258 vs $144 for the Prep-Tite 3i abutment for an additional cost of $114.

TOTAL COST FOR SINGLE TOOTH REPLACEMENT WITH 3I OSSEOTITE:

With a preparable Prep-Tite Abutment: 255 + 49 + 98 + 42 + 46 + 12 = $502
With an STA Abutment: 255 + 49 + 188 + 42 + 70 + 12 = $616
 
IMPLANT AND RESTORATIVE COSTS FROM PARAGON
 
External Hex Taper-Lock Implant: Total cost using Paragon's Taper-Lock External Hex 4.7mmD implant, made of work-hardened Grade IV titanium (2X stronger than 3i), with SBM-Blasted Surface, triple lead threads, friction-fit tapered external hex and Fixture Mount/Transfer/Temporary Abutment Packaging = $125

Preparable Straight Abutment in 3 Emergence Profiles = $55
Using abutments without shoulders not only eliminates the need to select the appropriate gingival cuff height for an abutment, it allows surgeons to attach the abutment at second stage, maintaining the tissue opening.

TOTAL COST FOR SINGLE TOOTH REPLACEMENT WITH PARAGON:
Taper-Lock cost for single tooth replacement = $125 + 55 = $180
SwissPlus Implant includes Fixture Mount that is Transfer and Abutment = $180
SAVINGS vs 3i with its Preparable Abutment $502 - 180 = $332
SAVINGS vs 3i with STI Abutment $616 - 180 = $436

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