Keystone Dental GENESIS Implant System Surgical Manual

Contact Us:
Phone: 866-902-9272
781-328-3490
Trademark Acknowledgements
Prima, PrimaConnex, PrimaSolo, RENOVA, RESTORE, STAGE-1, DynaBlast, DynaGraft•D, DynaMatrix, CalMatrix, CalForma, TefGen-FD, TefGen-Plus,
TefGen, TiLobe, BioSpark, AnaTite, SureConnect and SureAllign are trademarks of Keystone Dental, Inc.
Manufacturer
Keystone Dental, Inc.
144 Middlesex Turnpike
Burlington, MA 01803 USA
Call:1-866-902-9272
Fax:1-866-903-9272
Authorized Representative
Keystone Dental SpA
via A. Fleming, 19
37135 Verona, Italy
Call:+39-045-8230294
Fax:+39-045-8250296
Subsidiary:
Keystone Dental GmbH
Alfter, Germany
Call:+49-2222-9294-0
Fax:+49-2222-977356
Outside the USA
Call:+1-781-328-3490
Fax:+1-781-328-3400
Subsidiary:
Keystone Dental AB
Särö, Sweden
Call:+46-31-93-68-23
Fax:+46-31-93-68-45
Subsidiary:
Keystone Dental S.A.S.
Beauzelle, France
Call:+33-5-62-21-40-45
Fax:+33-5-61-42-06-32
Email: [email protected]
www.keystonedental.com
0123
Caution,
consult accompanying documents
only
The products described herein are covered by one or more of the following patents:
US 5,996,779, US 6,142,296, US 7,249,949, and applicable international patents.
Additional patents are pending.
© Keystone Dental, Inc. 2010
001-0969-00
Rev A
10/2010
GENESIS Implant System
Surgical Manual
Fax:
866-903-9272
781-328-3400
Mail:
Keystone Dental, Inc.
144 Middlesex Turnpike
Burlington, MA 01803 USA
www.keystonedental.com
Contact Us:
Phone: 866-902-9272
781-328-3490
Trademark Acknowledgements
Prima, PrimaConnex, PrimaSolo, RENOVA, RESTORE, STAGE-1, DynaBlast, DynaGraft•D, DynaMatrix, CalMatrix, CalForma, TefGen-FD, TefGen-Plus,
TefGen, TiLobe, BioSpark, AnaTite, SureConnect and SureAllign are trademarks of Keystone Dental, Inc.
Manufacturer
Keystone Dental, Inc.
144 Middlesex Turnpike
Burlington, MA 01803 USA
Call:1-866-902-9272
Fax:1-866-903-9272
Authorized Representative
Keystone Dental SpA
via A. Fleming, 19
37135 Verona, Italy
Call:+39-045-8230294
Fax:+39-045-8250296
Subsidiary:
Keystone Dental GmbH
Alfter, Germany
Call:+49-2222-9294-0
Fax:+49-2222-977356
Outside the USA
Call:+1-781-328-3490
Fax:+1-781-328-3400
Subsidiary:
Keystone Dental AB
Särö, Sweden
Call:+46-31-93-68-23
Fax:+46-31-93-68-45
Subsidiary:
Keystone Dental S.A.S.
Beauzelle, France
Call:+33-5-62-21-40-45
Fax:+33-5-61-42-06-32
Email: [email protected]
www.keystonedental.com
0123
Caution,
consult accompanying documents
only
The products described herein are covered by one or more of the following patents:
US 5,996,779, US 6,142,296, US 7,249,949, and applicable international patents.
Additional patents are pending.
© Keystone Dental, Inc. 2010
001-0969-00
Rev A
10/2010
GENESIS Implant System
Surgical Manual
Fax:
866-903-9272
781-328-3400
Mail:
Keystone Dental, Inc.
144 Middlesex Turnpike
Burlington, MA 01803 USA
www.keystonedental.com
table of contents
product characteristics
2
1. Surface Technology
2
2. Connection
2
3. Icon Descriptions
3
PRE-SURGICAL CONSIDERATIONS (Treatment Planning)
4
1. Patient Evaluation and Selection
4
2. Biomechanics
4
3. Bone Quality
5
4. Surgical Guide
5
5. Implant Selection
6
6. Implant Sizing Overlays
6
SURGERY
7
1. Surgical Kit
7
2. Drilling and Tapping Procedures
8
3. Cleaning and Sterilization of Instruments
8
4. Cleaning and Sterilization of Surgical Ratchet/Torque Wrench
10
5. Drilling Depth Marking Information and Sequence
10
6. Implant Packaging
11
7. Implant Insertion
12
8. Implant Placement
13
SURGICAL PROCEDURE – Tapered & Straight Implants
14
Drilling and Tapping Procedure (Full Flap Reflection)
14
Implant Procedure
18
Post Surgery
19
QUICK REFERENCE GUIDE
20
Sequence Reference Guide
20
Tap and Countersink Protocols
23
Symbols Key
= Caution
= Note
= Tip
2
product characteristics
PRODUCT CHARACTERISTICS
1. Surface Technology
All Genesis Implants are manufactured with Grade 4 biocompatible titanium and treated with the
BioSpark™ process. They are indicated for all bone types and are intended to be used in the following
clinical applications:
a. Single missing tooth, partially edentulous, or fully edentulous
b. Upper and lower jaws, anterior and posterior regions
c. One or two stage protocols
d. Placement at time of extraction and/or immediate
temporization
BioSpark™ Surface
Technology
The BioSpark™ process is a surface modification that is unique to the
Genesis Implant System.
Grade 4 Titanium
2. Connection
8.5˚ Taper
Keystone Dental’s Genesis Implant System
incorporates TiLobe™ Technology, a patented
internal 6-lobed connection that combines the
benefits of a taper, internal lobed design and
integrated pilots, providing a secure implant/
abutment connection. The TiLobe™ connection
utilizes the same screw throughout all implant
diameters. The 5.5 and 6.5mm implant diameters
also share the same prosthetic connection.
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6-Lobed Connection
Abutment Guiding Pilot
Tapered Design
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Straight Design
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3. Icon Descriptions
The Genesis Implant System is designed with color-coded icons on the product labeling to help the
clinician identify the correct abutment for a specific implant diameter. Each icon below represents the
diameters of the Genesis Implant System that are currently available.
3.8mm Ø Straight and Tapered
Available in lengths of 8.5, 10, 11.5, 13, and 16mm
Implant Diameter
Implant Length
4.5mm Ø Straight and Tapered
Available in lengths of 8.5, 10, 11.5, 13, and 16mm
5.5mm Ø Tapered Only
Available in 8.5, 10, 11.5, and 13mm
6.5mm Ø Tapered Only
Available in 8.5, 10, 11.5, and 13mm
Using the color coded implant icon that was selected, the clinician chooses the correct abutment
by matching it to one of many options that share a similar color-coded identifier. The scheme below
identifies the abutments that can be used with each implant diameter.
Can use 4.0 and 5.0 prosthetic components to mate with the 3.8mm Ø Implant.
Can use 5.0 and 6.0 prosthetic components to mate with the 4.5mm Ø Implant.
Can use 5.0 prosthetic components to mate with the 5.5mm Ø Implant.
Can use 6.0 prosthetic components to mate with the 5.5/6.5 Ø Implants.
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pre-surgical considerations
PRE-SURGICAL CONSIDERATIONS (Treatment Planning)
1. Patient Evaluation and Selection
Successful implant treatment requires the coordinated efforts of the implanting surgeon, the
restorative dentist, and the dental laboratory technician. Pre-surgical treatment option discussions
between these individuals determine the appropriate treatment strategy and add balance between
the surgical objectives and aesthetic, phonetics, and function of the final prosthesis. In addition, this
coordinated approach ensures that treatment is complete, there is no omission of important technical
considerations such as the use of a surgical guide for implant positioning, and that the biomechanics
of the final prosthesis are maintained.
Proper patient selection is important for long-term function of a dental implant. The following factors
should be considered prior to implant surgery:
• General medical history
• Oral Hygiene
• Patient’s expectations
• General dentistry and product indications and contraindications
• Anatomical landmarks related to implant positioning
• Inter-occlusal clearance – the space available between alveolar crest and opposing dentition
• Bone volume at the implant site in relationship to the implant diameter
• Emergence profile of the restoration in relation to the diameter of the prosthetic platform
2. Biomechanics
Proper stress distribution is essential to the long-term success of both the prosthesis and the implant.
Overload of the implant or one particular area of the implant are key contributors to failure and are
especially critical in placements in the cuspid and molar regions.
To minimize excessive and improperly distributed loads, the following guidelines apply:
• Decrease occlusal forces transferred to the implant by reducing the occlusal table width of
the prosthesis
• Distribute occlusal forces optimally by maximizing the number of abutments used to support
the prosthesis
• Use implants to maximize the potential for long-term esthetics and restorative success
• Plan the position and inclination of the implants to ensure good prosthetic design, function,
and esthetics
• Direct forces of occlusion along the long axis of the implant
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• Avoid cantilevering wherever possible
• Strengthen the overall treatment plan in patients with a heavy muscular profile or whose occlusal
analysis indicates a strong bite
• Consider the forces from the opposing dentition
3. Bone Quality
Bone quality should be considered because it is an important factor when selecting the number,
length and diameter of implants. Use particular care in selection and placement of implants
dependent on the type of surrounding bone environment. The following bone classifications are
depicted by regions where they are typically found in the oral cavity and should be considered when
implant selection decisions are made.
Cortical – Dense bone
Trabecular – Soft bone
D1 BoneD2 BoneD3 BoneD4 Bone
Cortical Bone
Cortical Bone
Some dense Trabecular
Thin Cortical
Medium density Trabecular
Very thin Cortical
Low density Trabecular
4. Surgical Guide
The implanting surgeon, the restoring dentist, and the laboratory technician should work together
to produce diagnostic wax-ups and a surgical guide. This teamwork assists the implanting surgeon
in the proper positioning of the implant(s). A surgical guide is used to indicate practical boundaries
for the placement of implants and may prevent implants from being placed too buccal/lingually or
mesial/distally. This process helps to ensure functional placement of implants and esthetic results. The
implanting surgeon should communicate to the laboratory technician any conditions that may affect
guide design (e.g., the type of incision that will be used, expected reflection of tissue, etc.)
Keystone Dental offers the EasyGuide™ dental implant planning and placement system; a planning
software that allows virtual planning of dental implant surgery cases based on the patient’s Computer
Tomography (CT) scan data, and a service where the radiographic guide worn by the patient during
the CT scan is then converted into a precise surgical guide. Refer to the EasyGuide literature for
detailed information on the products and procedures.
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pre-surgical considerations
5. Implant Selection
Implant selection should be made with the final restorative result as the primary consideration. This
leads to better selection of the appropriate diameter and length based on the structure of the bone
where the implant is intended to be placed and the inter-dental space that is available.
Selecting implants in this manner will provide maximum biomechanical stability and proper
contouring of the soft tissue. Choosing an implant with a slightly smaller platform than the
emergence of the tooth being replaced will provide support of the soft tissue and optimize the
esthetic result.
Implant placement and healing abutment selections are based on the relationship of the following
key measurements:
• Emergence of the restoration in relation to the diameter of the implant
• Height and diameter of the crown as it emerges through the tissue
• Bone quality and quantity in relation to the implant diameter and length
The following guide can be used to determine the appropriate implant diameters that are
recommended based on the tooth shapes shown below.
{
5.5 Ø 6.5 Ø 3.8 Ø or 4.5 Ø
4.5 Ø 3.8 Ø
4.5
or 5.5 Ø
Implant Diameters
6
5.5 Ø 6.5 Ø 4.5 Ø
4.5 Ø
4.5 Ø
3.8 Ø 3.8 Ø
6. Implant Sizing Overlays
Implant selection can also be made with the use of sizing overlays which are used as part of the presurgical assessment. Overlays are to be used in conjunction with radiographs. Transparent Implant
Sizing Overlays (100% and 125% magnification) are included with each Genesis Surgical Kit.
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surgery
SURGERY
1. Surgical Kit
The first step in surgery is for you and your surgical staff members to become familiar with the surgical
kit. The Genesis Surgical Kit holds all the instrumentation needed to place all diameters and lengths of
Genesis tapered and straight implants. Drills and Taps are sold as sets and can be purchased separately
depending on the clinician’s implant preference. These additional instruments are designed to be
placed within the kit in their defined locations. All drills are non-irrigated and require external irrigation
when preparing the osteotomy.
Instrumentation
NOTE: All Genesis Implant System surgical instruments are provided non-sterile and
require sterilization prior to use. Always remove the instruments from the packaging
before sterilization.
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8
surgery
Prior to using any instrumentation, always inspect to ensure that there is no visible damage or excess
wear. Also, ensure that sterilization has been completed. It is important to observe the number of
sterilization cycles or uses to which drills have been subjected as drills will become dull after multiple
uses. This could impact cutting performance ultimately minimizing the potential for success of the
procedure. Keystone Dental recommends drill replacement after 20 osteotomies, although wearing
may occur more rapidly in denser bone surgeries. Always have a backup drill sterile and available.
2. Drilling and Tapping Procedures
• Drilling speeds of 600 - 800 rpm are recommended when using Initial and Intermediate drills.
• Drilling speeds should not exceed 600 rpm when using Final drills.
• In certain instances, tapping is required (see Step 12 in Surgical Procedure Section). When tapping
of the bone is required, a maximum tapping speed of 20 rpm is recommended.
• All drilling and tapping procedures should be performed using copious external irrigation.
• Do not apply lateral pressure during drilling and tapping procedures as osteotomy may be
oversized and/or redirected.
• Drill the osteotomy using light pressure. When using the Initial and Intermediate Drills, drill in an
in-and-out motion along the long axis of the osteotomy.
• When using tapered or countersink drills, do not use the in-and-out technique since this may
inadvertently enlarge the site. Instead, drill the site to the desired depth in one motion.
3. Cleaning and Sterilization of Instruments
It is important to ensure all instrumentation, surgical handpieces, and equipment that are provided
non-sterile are sterilized prior to use to prevent the possible contamination of the components and
surgical field. Always remove these components from their packaging prior to introduction into the
sterile field.
It is recommended that the proper biological indicators for the selected sterilization method
accompany each load prior to sterilization and that the appropriate sterile packaging be used to
maintain sterility until use. Each dental office is responsible for the proper, routine sterilization of
instruments. All sterilization techniques should follow guidelines recommended by the sterilizer
manufacturer.
Perform the following to properly clean and sterilize the instruments:
Cleaning Procedure for Surgical Trays and Instrumentation
1. Disassemble the surgical kit and wash the tray using a detergent solution. Rinse the tray with water
and dry thoroughly.
2. Place the instruments in a beaker of detergent solution and sonicate for approximately 10 minutes.
Rinse thoroughly.
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3. Remove any visible debris or bone fragments with a soft bristle brush. Rinse thoroughly.
4. Rinse the instruments with alcohol to remove soap residue and minerals. (This is important to help
prevent corrosion.)
5. Blot the instruments with a clean towel(s) and allow to air dry completely.
6. Return the instruments to their appropriate locations in the surgical tray.
7. Wrap the kit in a double-layer of autoclave-wrap.
8. Sterilize the kit according to the sterilization method specified in the next section.
CAUTION: Do not remove the surgical kit from the autoclave until the dry cycle is
complete. Upon removal from the autoclave, visually ensure instruments are dry as
corrosion potential increases with exposure to moisture.
CAUTION: The use of hydrogen peroxide or other oxidizing agents will cause damage to
the surface of the instruments.
CAUTION: It is important to handle all drills carefully. Even slight damage to their
cutting edges impedes the drills cutting performance considerably. Proper care of the
instruments is essential to maintaining performance. Keep drills separate during cleaning
in order to prevent dulling by contact with other instruments.
Sterilization Method
Autoclave:
Steam Sterilization Gravity Cycle: 134˚C (~273°F) 20 minute exposure / 40 minute dry time
Steam Sterilization Pre Vacuum Cycle: 134˚C (~273°F) 4 minute exposure / 40 minute dry time
CAUTION: Do not exceed 140°C (284°F) for either cycle used.
CAUTION: Autoclave sterilization can only be accomplished by placing the individual
components in the surgical tray, a sealed autoclave bag or in a surgical towel.
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surgery
CAUTION: To minimize the potential for drill rusting, always use a drying cycle following
sterilization.
CAUTION: Do not use chemclave sterilization procedures as they may damage surgical
trays and/or instruments.
4. Cleaning of Surgical Ratchet/Torque Wrench
After each use the surgical ratchet/torque wrench should be dismantled, disinfected and sterilized.
To prevent drying of contaminants, place the instrument parts in a disinfectant/detergent solution.
Do not use solutions containing oxalic acid or a high concentration of chlorine. If appropriate,
combine with ultrasound cleaning. Rinse the instrument parts in hot water and dry thoroughly. Follow
the above Sterilization Method for autoclave procedure.
5. Drilling Depth Marking Information
and Sequence
The Genesis Implant System drill laser markings define
placement depth of the implant. These laser marks
indicate full implant lengths; plus an overdrill length
(see page 11 for overdrill length). The implant placement
protocol is to position the implant so the pink collar is at
bone level.
16mm
As a secondary visual check to ensure proper osteotomy
depth, a depth gauge is included in the surgical kit. The
depth gauge also has corresponding laser markings to
indicate osteotomy depth.
The figures to the right show the various laser markings
used on Genesis Implant System surgical instrumentation
where needed to indicate the corresponding implant
depth.
13mm
11.5mm
10mm
8.5mm
Intermediate Drills
Final Drills
CAUTION: Ensure drill tip length is considered when drilling near critical anatomical
locations (e.g., nerve canal).
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The length of the drill tip is not included in the depth marking measurement calculation. The actual
drill length including the tip must be considered when preparing the osteotomy. The charts below
list the lengths of the drill tips for each drill in the Genesis Implant System and show the various laser
markings to indicate corresponding implant depth.
depth gauge
image
to come
}
Over drill length
Intermediate Drills
Over drill length
Final Drills
Over drill length
2.7mm Intermediate Drill
0.93mm
3.8mm Tapered Final Drills
0.93mm
3.2mm Intermediate Drill
1.03mm
4.5mm Tapered Final Drills
1.03mm
4.2mm Intermediate Drill
1.03mm
5.5mm Tapered Final Drills
1.03mm
5.2mm Intermediate Drill
1.53mm
6.5mm Tapered Final Drills
1.53mm
3.8mm Straight Final Drills
0.93mm
4.5mm Straight Final Drills
1.03mm
6. Implant Packaging
Each Genesis Implant is packaged in an aseptic vial, sealed in a tray with a Tyvek® lid and gammasterilized. The vial has a titanium insert to support the implant during shipment. The flip-open lid on
the vial contains a pink cover screw, to mimic gingival tissue, and is included with every implant. The
tray is placed in an outer package and sealed with a label identifying the implant type, diameter and
length, as well as other important device information. Inside the sealed tray you will find pre-printed
patient labels with product data and the lot number. These are adhesive labels that should be affixed
to the patient’s chart. Below you will find the steps to opening the implant packaging.
1. Remove implant tray from outer package.
2. Peel back the Tyvek lid on the tray and place the sterile implant vial into the sterile field.
3. Place the patient labels in the patient’s chart.
4. Remove the seal from the vial.
5. Flip open the implant vial to gain access to the selected Genesis Implant.
6. T
he implant may now be removed from the vial, delivered to the site and
placed using one of the options found in Section # 7 (Implant Insertion).
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surgery
7. Implant Insertion
Depending on the clinical situation and accessibility, there are three different options to insert the
Genesis Implant:
1. Surgical Motor with Implant Driver/Latch Type
2. Surgical Ratchet with Implant Driver/Ratchet
3. Hand Driver with Implant Driver/Latch Type
Mountless Delivery System
The Genesis Implant System is designed with a mountless delivery system to facilitate the delivery of
the implant from the vial to the osteotomy. Care should always be taken when inserting the implant
driver tip into the implant. Each implant diameter requires its own specific implant driver, except for
the 5.5/6.5mm implants, which share a common connection. With the Implant Driver/Latch Type,
align the Implant Driver over the connection of the implant. Press down firmly until the driver firmly
engages with the connection of the implant. Remove the implant from the vial and carry to the
implant site
The implant cover screw is located within the cap of the vial. Placement of the cover screw into the
implant can be achieved with the use of the Quad Driver, Swivel Head found in the surgical kit.
The following demonstrates removal from the vial and placement of the implant into the osteotomy
using the Implant Driver/Latch type:
Flip open Implant Vial to
expose the implant. Using
your Implant Driver/Latch type
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8. Implant Placement
Final placement of a Genesis Implant is up to the discretion of the implanting surgeon. Each case
should be evaluated on the basis of placement, protocol and type of implant before the osteotomy
is drilled. The availability of the two types of Genesis implants (straight or tapered) allows the
surgeon to address different anatomical situations, weigh the advantages of each, and choose
the type that best suits the individual case. Keystone Dental recommends placement of a Genesis
Implant at bone level.
Tapered Implants
Genesis Tapered Implants are designed to address anatomic conditions such
as converging roots of adjacent teeth, lingual undercuts in the mandible, and
labial concavities in the maxilla. By utilizing a tapered implant design in these
conditions, optimal implant placement and ideal esthetics can be achieved.
The chart below describes the Genesis Implant System catalog numbers for
the various tapered implant diameters and lengths:
Implant
8.5mm (L)
10mm (L)
11.5mm (L)
13mm (L)
16mm (L)
3.8mm Ø
G21130
G21131
G21132
G21133
G21135
4.5mm Ø
G21137
G21138
G21139
G21140
G21142
5.5mmØ
G21144
G21145
G21146
G21147
6.5mm Ø
G21150
G21151
G21152
G21153
Straight Implants
Genesis Straight Implants are consistent in design, self-tapping and can be
used for all treatment indications in which sufficient bone volume is available.
The straight design provides placement versatility and is suitable for virtually
all case designs. The chart below describes the Genesis Implant System
catalog numbers for the various straight implant diameters and lengths:
Implant
8.5mm (L)
10mm (L)
11.5mm (L)
13mm (L)
16mm (L)
3.8mm Ø
G21117
G21118
G21119
G21120
G21122
4.5mm Ø
G21123
G21124
G21125
G21126
G21128
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surgical procedure
SURGICAL PROCEDURE — TAPERED & STRAIGHT IMPLANTS
Place all instrumentation and implants onto the sterile work field in the order they will be used. This
makes for a natural progression through the sequence of the case. For convenience, the surgical kit is
also set up in this configuration.
NOTE: For demonstration purposes the instructions provided below are for the Genesis
4.5 x 13mm Implant only. For implants with other diameters refer to the drilling sequence
charts found in the back of this manual.
Drilling and Tapping Procedure (Full Flap Reflection)
Step 1 – Anesthesia
Anesthesia requirements are left to the discretion of the treating
surgeon. If traditional flap reflection type surgery is desired, the
administration of local anesthesia may be used.
Step 2 – Incision
Make an incision of appropriate design to elevate a flap. When working
with the anterior mandible, locate the mental foramen and the inferior
alveolar nerve.Perform alveoloplasty on the crest of the ridge, if
needed, to create a more even plane in which to place the implant.
Step 3 - Implant Selection
Using the guidelines provided above, select the appropriate implant
diameter and length.
NOTE: Optional: Drill Extender – A Drill Extender is
provided within the Genesis Implant System surgical kit
to provide additional length to the drills for tight areas
between teeth. To use the Drill Extender extension, insert
the latch-end of a drill into the drill extender and push
until it is firmly seated.
Step 4 – 2.0mm Initial Drill (Recommended drilling speed 600 - 800 rpm)
Select the 2.0 mm Initial Drill. Drill directly through the alveolar crest.
Continue to penetrate the bone below the crest to the laser mark on
the drill. A round bur may be used as a guide to penetrate the bone at
the marked implant site. These drills will provide valuable information
about the bone quality.
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Step 5 – 2.0 Parallel Pin
Verify the correct direction and position of the osteotomy by use of the
Parallel Pin. Insert the smaller end of the pin into the osteotomy. It is
recommended to thread floss through the hole to prevent slippage and
possible accidental swallowing.
Step 6 – 2.7mm Intermediate Drill
(Recommended drilling speed is 600 – 800 rpm)
Use the 2.7 mm Intermediate Drill and enlarge the osteotomy by drilling
to the 13mm depth line.
NOTE: Intermediate Drills feature multiple depth indicators.
Complete depth marking Information can be found in the
Drilling Depth Marking Information and Sequence section.
NOTE: With the exception of the 2.0mm Initial Drill, all
drill tips have a built-in step that is the same diameter as
the preceding drill. This tip allows the drill to seat into the
prepared osteotomy without causing damage or skittering
on the bone.
Step 7 – Radiographic 2.7mm Depth Gauge (Optional)
If desired, use the 2.7mm Depth Gauge to verify that the osteotomy has
been prepared to the required depth. If necessary the 2.7mm Depth
Gauge may be left in the site for radiographic verification.
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surgical procedure
Step 8 – 3.2mm Intermediate Drill
(Recommended drill speed 600 – 800 rpm)
Use the 3.2mm Intermediate Drill and enlarge the osteotomy by drilling
to the 13mm depth line.
Step 9 – Radiographic 3.2 Depth Gauge (Optional)
If desired, use the 3.2mm Depth Gauge to verify that the osteotomy has
been prepared to the required depth. If necessary the 3.2mm Depth
Gauge may be left in the site for radiographic verification.
IF PLACING A STRAIGHT IMPLANT PROCEED TO STEP 10B, 11B & 12B
Step 10A – 4.5mm Tapered Countersink Drill (Tapered Protocol Only)
Once the final desired osteotomy depth has been verified, select the
4.5mm Countersink drill. This will prepare the superior portion of the
osteotomy for adaptation of the coronal portion of the implant. The
countersink corresponds to the actual diameter of the coronal aspect of
the implant. Drill to the appropriate laser mark on the drill.
NOTE: Use of a countersink for tapered implants is required
in Type I and Type II bone. It is up to the clinician’s discretion
in Type III and Type IV bone (Countersink use for the 3.8 and
4.5mm implants in Type IV bone is NOT recommended).
Step 10B – 4.5mm Straight Countersink Drill (Straight Protocol Only)
Once the final desired osteotomy depth has been verified, select the
4.5mm Countersink drill. This will prepare the superior portion of the
osteotomy for adaptation of the coronal portion of the implant. The
countersink corresponds to the actual diameter of the coronal aspect of
the implant. Drill to the appropriate laser mark on the drill.
NOTE: Use of a countersink for straight implants is
required in Type I and Type II bone. It is up to the clinician’s
discretion in Type III bone. Countersink use in Type IV bone
is NOT recommended.
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Step 11A – 4.5 mm Tapered Final Drills (Tapered Protocol only)
Select the 4.5mm Tapered Final Drill to shape the osteotomy in
preparation for the implant. Drill to the 13mm laser mark.
Step 11B – 4.5 mm Straight Final Drills (Straight Protocol only)
Select the 4.5mm Straight Final Drill to shape the osteotomy in
preparation for the implant. Drill to the 13mm laser mark.
Step 12A – 4.5mm Tapered Tapping Procedure (20 rpm)
NOTE: Tapping for tapered implants is required in Type I
and Type II bone (except for the 3.8/4.5 x 8.5mm and 3.8 x
10mm implants). Tapping in Type III and Type IV bone is
NOT recommended.
Place the 4.5 surgical Tap into the osteotomy. While applying “slight”
pressure begin rotating the tap (assure 20 rpm maximum). When the
threads begin engaging the bone, allow the tap to feed into the site
without applying any additional pressure. Tap to the laser mark. Reverse
the tap out of the osteotomy. The implant is now ready to be placed.
Step 12B – 4.5mm Straight Tapping Procedure (20 rpm)
NOTE: Tapping for all straight implants is required in Type
I and Type II bone. Tapping in Type III and Type IV bone is
NOT recommended.
Select the appropriate short or long tap, tap to the 13mm mark. Place
the 4.5 surgical Tap into the osteotomy. While applying “slight” pressure
begin rotating the tap (assure 20 rpm maximum). When the threads begin
engaging the bone, allow the tap to feed into the site without applying
any additional pressure. Reverse the tap out of the osteotomy. The
implant is now ready to be placed.
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18
surgical procedure
Implant Procedure
Step 13 – Implant Placement Open the outer implant package and remove the sealed tray containing
the implant.
A. Peel back the Tyvek® lid to expose the implant vial.
B. Invert the tray and allow the vial to “drop” into the sterile field.
In the sterile field using a sterile technique, flip open the implant vial cap
to expose the Genesis Implant. The implant may now be removed from
the vial, delivered to the site and placed using:
1. Surgical Motor with Implant Driver/LatchType
2. Surgical Ratchet with Implant Driver/Ratchet
3. Hand Driver with Implant Driver/Latch Type Thread the implant into the osteotomy at approximately 20 rpm until the
coronal portion of the implant is flush with the top of the bone. Do not
over-tighten the implant in the site, as this could damage the threads
prepared in the bone, cause too much bone-to-implant pressure and
result in a less than optimal fixation.
NOTE: In some clinical situations, the clinician may prefer
to use the Surgical Ratchet with Implant Driver/Ratchet to
manually tighten the last few rotations and fully seat the
implant. This allows for a better tactile feel during seating.
Step 14 – Cover Screw Placement
The cover screw is located in the vial cap. To remove the
Cover Screw from the cap, connect the Quad Implant
Driver to the Cover Screw, turn counterclockwise and free
the Cover Screw from the cap. Carry the Cover Screw to
the Implant and tighten.
Step 15 – Closure and Suturing
Close and suture the tissue flap utilizing the desired
technique. It is suggested that a radiograph be taken to
use as a baseline of the implant-to-bone height.
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19
Post-Surgery
Patients should be instructed to follow a routine post-surgical regimen that includes ice or cold
packs for 24 hours post-implantation and to consume a soft, high-nutrient diet, if possible. According
to individual preference, consideration should also be given to advise dietary supplements with high
protein, high vitamin and high mineral content for up to a month. Anti-edema steroid therapy may
be initiated prior to surgery and continued for a period of 24 hours to one week post surgery.
Antibiotic treatment may be initiated one day pre-op and up to one week post-op as the patient’s
condition dictates.
Remove all sutures after approximately 10 days following implant placement or as an individual’s
soft tissue healing dictates. If a removable prosthesis is used during this initial healing phase, it
is recommended that a soft liner material be used to prevent pressure on the surgical site. The
prosthesis should be relieved over the implant site prior to the soft liner application. It is also advised
that the patient be examined periodically using radiographic evaluations to monitor healing of the
soft tissues and bone.
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sequence reference guide – tapered implants
QUICK REFERENCE GUIDE
The information found in this section is a Quick Reference Guide to the drilling sequence of placement
of all lengths and diameters found in the Genesis Implant System.
DRILL SEQUENCE – TAPERED IMPLANTS
3.8MM TAPERED IMPLANT LENGTHS
8.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Tapered
Final Drill
10mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Tapered
Final Drill
11.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Tapered
Final Drill
3.8mm x 11.5/13/16mm
Surgical Tap
13mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Tapered
Final Drill
3.8mm x 11.5/13/16mm
Surgical Tap
16mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Tapered
Final Drill
3.8mm x 11.5/13/16mm
Surgical Tap
4.5MM TAPERED IMPLANT LENGTHS
8.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm Tapered
Final Drill
10mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm Tapered
Final Drill
4.5mm x
10/11.5/13mm
Surgical Tap
11.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm Tapered
Final Drill
4.5mm x
10/11.5/13mm
Surgical Tap
13mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm Tapered
Final Drill
4.5mm x
10/11.5/13mm
Surgical Tap
16mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm Tapered
Final Drill
4.5mm x 16mm
Surgical Tap
NOTE: Tapping for tapered implants is required in Type I and Type II bone (except for
the 3.8/4.5 x 8.5mm and 3.8 x 10mm implants). Tapping in Type III and Type IV bone is
NOT recommended.
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1-781-328-3490 (International)
21
DRILL SEQUENCE & DEPTH MARKING INFORMATION – TAPERED IMPLANTS
5.5MM TAPERED IMPLANT LENGTHS
8.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
Depth
Gauge
(optional)
5.5mm
Countersink
5.5mm Tapered
Final Drill
5.5mm x 8.5mm
Surgical Tap
10mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
Depth
Gauge
(optional)
5.5mm
Countersink
5.5mm Tapered
Final Drill
5.5mm x
10/11.5/13mm
Surgical Tap
11.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
Depth
Gauge
(optional)
5.5mm
Countersink
5.5mm Tapered
Final Drill
5.5mm x
10/11.5/13mm
Surgical Tap
13mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
Depth
Gauge
(optional)
5.5mm
Countersink
5.5mm Tapered
Final Drill
5.5mm x
10/11.5/13mm
Surgical Tap
6.5MM TAPERED IMPLANT LENGTHS
8.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
5.2mm
Intermediate
Drill
Depth
Gauge
(opt.)
6.5mm
C-sink
6.5mm Tapered
Final Drill
6.5mm x 8.5mm
Surgical Tap
10mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
5.2mm
Intermediate
Drill
Depth
Gauge
(opt.)
6.5mm
C-sink
6.5mm Tapered
Final Drill
6.5mm x
10/11.5/13mm
Surgical Tap
11.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
5.2mm
Intermediate
Drill
Depth
Gauge
(opt.)
6.5mm
C-sink
6.5mm Tapered
Final Drill
6.5mm x
10/11.5/13mm
Surgical Tap
13mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate
Drill
3.2mm
Intermediate
Drill
4.2mm
Intermediate
Drill
5.2mm
Intermediate
Drill
Depth
Gauge
(opt.)
6.5mm
C-sink
6.5mm Tapered
Final Drill
6.5mm x
10/11.5/13mm
Surgical Tap
NOTE: Tapping for tapered implants is required in Type I and Type II bone (except for
the 3.8/4.5 x 8.5mm and 3.8 x 10mm implants). Tapping in Type III and Type IV bone is
NOT recommended.
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sequence reference guide – straight implants
DRILL SEQUENCE & DEPTH MARKING INFORMATION STRAIGHT IMPLANTS
3.8MM STRAIGHT IMPLANT LENGTHS
8.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Straight Final Drill
3.8mm
Surgical Tap
10mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Straight Final Drill
3.8mm
Surgical Tap
11.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Straight Final Drill
3.8mm
Surgical Tap
13mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Straight Final Drill
3.8mm
Surgical Tap
16mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
Depth Gauge
(optional)
3.8mm
Countersink
3.8mm
Straight Final Drill
3.8mm
Surgical Tap
4.5MM STRAIGHT IMPLANT LENGTHS
8.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm
Straight Final Drill
4.5mm
Surgical Tap
10mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm
Straight Final Drill
4.5mm
Surgical Tap
11.5mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm
Straight Final Drill
4.5mm
Surgical Tap
13mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm
Straight Final Drill
4.5mm
Surgical Tap
16mm
2.0
Initial
Drill
Parallel
Pins
2.7mm
Intermediate Drill
3.2mm
Intermediate
Drill
Depth Gauge
(optional)
4.5mm
Countersink
4.5mm
Straight Final Drill
4.5mm
Surgical Tap
NOTE: Tapping for straight implants is required in Type I and Type II bone. Tapping in
Type III and Type IV bone is NOT recommended.
Keystone Dental, Inc.
866-902-9272 (U.S.A.)
1-781-328-3490 (International)
tap protocols
3.8mm Implants – Tapered (Tap)
3.8MM IMPLANTS
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
8.5mm Implant
Not Recommended
Not Recommended
Not Recommended
Not Recommended
10mm Implant
Not Recommended
Not Recommended
Not Recommended
Not Recommended
11.5mm Implant
Required
Required
Not Recommended
Not Recommended
13mm Implant
Required
Required
Not Recommended
Not Recommended
16mm Implant
Required
Required
Not Recommended
Not Recommended
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
8.5mm Implant
Not Recommended
Not Recommended
Not Recommended
Not Recommended
10mm Implant
Required
Required
Not Recommended
Not Recommended
11.5mm Implant
Required
Required
Not Recommended
Not Recommended
13mm Implant
Required
Required
Not Recommended
Not Recommended
16mm Implant
Required
Required
Not Recommended
Not Recommended
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
8.5mm Implant
Clinician’s Discretion
Clinician’s Discretion
Not Recommended
Not Recommended
10mm Implant
Required
Required
Not Recommended
Not Recommended
11.5mm Implant
Required
Required
Not Recommended
Not Recommended
13mm Implant
Required
Required
Not Recommended
Not Recommended
4.5mm Implants – Tapered (Tap)
4.5MM IMPLANTS
5.5mm Implants – Tapered (Tap)
5.5MM IMPLANTS
6.5mm Implants – Tapered (Tap)
6.5MM IMPLANTS
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
8.5mm Implant
Clinician’s Discretion
Clinician’s Discretion
Not Recommended
Not Recommended
10mm Implant
Required
Required
Not Recommended
Not Recommended
11.5mm Implant
Required
Required
Not Recommended
Not Recommended
13mm Implant
Required
Required
Not Recommended
Not Recommended
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
3.8mm Implants – Straight (Tap)
3.8MM IMPLANTS
8.5mm Implant
Required
Required
Not Recommended
Not Recommended
10mm Implant
Required
Required
Not Recommended
Not Recommended
11.5mm Implant
Required
Required
Not Recommended
Not Recommended
13mm Implant
Required
Required
Not Recommended
Not Recommended
16mm Implant
Required
Required
Not Recommended
Not Recommended
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
4.5mm Implants – Straight (Tap)
4.5MM IMPLANTS
8.5mm Implant
Required
Required
Not Recommended
Not Recommended
10mm Implant
Required
Required
Not Recommended
Not Recommended
11.5mm Implant
Required
Required
Not Recommended
Not Recommended
13mm Implant
Required
Required
Not Recommended
Not Recommended
16mm Implant
Required
Required
Not Recommended
Not Recommended
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24
countersink protocols
3.8mm Implants – Tapered (Countersink)
3.8MM IMPLANTS
8.5mm Implant
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
Required
Required
Clinician’s Discretion
Not Recommended
10mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
11.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
13mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
16mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
TYPE III BONE
TYPE IV BONE
4.5mm Implants – Tapered (Countersink)
3.8MM IMPLANTS
TYPE 1 BONE
TYPE II BONE
8.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
10mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
11.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
13mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
16mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
TYPE III BONE
TYPE IV BONE
5.5mm Implants – Tapered (Countersink)
5.5MM IMPLANTS
TYPE 1 BONE
TYPE II BONE
8.5mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
10mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
11.5mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
13mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
6.5mm Implants – Tapered (Countersink)
5.5MM IMPLANTS
8.5mm Implant
TYPE 1 BONE
TYPE II BONE
TYPE III BONE
TYPE IV BONE
Required
Required
Clinician’s Discretion
Clinician’s Discretion
10mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
11.5mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
13mm Implant
Required
Required
Clinician’s Discretion
Clinician’s Discretion
TYPE III BONE
TYPE IV BONE
3.8mm Implants – Straight (Countersink)
3.8MM IMPLANTS
TYPE 1 BONE
TYPE II BONE
8.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
10mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
11.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
13mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
16mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
TYPE III BONE
TYPE IV BONE
4.5mm Implants – Straight (Countersink)
3.8MM IMPLANTS
TYPE 1 BONE
TYPE II BONE
8.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
10mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
11.5mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
13mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
16mm Implant
Required
Required
Clinician’s Discretion
Not Recommended
Keystone Dental, Inc.
866-902-9272 (U.S.A.)
1-781-328-3490 (International)
Contact Us:
Phone: 866-902-9272
781-328-3490
GENESIS Implant System
Trademark Acknowledgements
TiLobe, BioSpark, AnaTite, SureConnect and SureAlign are trademarks of Keystone Dental, Inc.
Surgical Manual
Manufacturer
Keystone Dental, Inc.
144 Middlesex Turnpike
Burlington, MA 01803 USA
Call: 1-866-902-9272
Fax: 1-866-903-9272
Authorized Representative
Keystone Dental SpA
via A. Fleming, 19
37135 Verona, Italy
Call: +39-045-8230294
Fax: +39-045-8250296
Subsidiary:
Keystone Dental GmbH
Alfter, Germany
Call: +49-2222-9294-0
Fax: +49-2222-977356
Outside the USA
Call: +1-781-328-3490
Fax: +1-781-328-3400
Subsidiary:
Keystone Dental AB
Särö, Sweden
Call: +46-31-93-68-23
Fax: +46-31-93-68-45
Subsidiary:
Keystone Dental S.A.S.
Beauzelle, France
Call: +33-5-62-21-40-45
Fax: +33-5-61-42-06-32
Email: [email protected]
www.keystonedental.com
0123
Caution,
consult accompanying documents
only
The products described herein are covered by one or more of the following patents:
US 5,996,779, US 6,142,296, US 7,249,949, and applicable international patents.
Additional patents are pending.
© Keystone Dental, Inc. 2010
100001-EN01
Rev A
10/2010
Fax:
866-903-9272
781-328-3400
Mail:
Keystone Dental, Inc.
144 Middlesex Turnpike
Burlington, MA 01803 USA
www.keystonedental.com