Astra Tech Implant System ATIS EV Surgical Manual March 2017

The Astra Tech Implant System EV is designed for ease of use and versatility in providing treatment solutions for your implant patients. The foundation of this evolutionary system remains the unique Astra Tech Implant System BioManagement Complex, which has been proven to predictably provide long-term marginal bone maintenance and esthetic results.

Astra Tech Implant System® CONTENTS Introduction – Astra Tech Implant System® EV Drilling protocol and bone classification

4

Implant assortment

4

Implant size/tooth position

5

Interface connection

5

Tray concept

6

Color coding

8

Treatment planning Pre-operative procedures

9

Clinical application

10

Implant site preparation Surgical components and instruments overview

12

Implant packaging and handling

16

Drilling protocol

18

Expanded drilling protocol

20

Osteotomy preparation

21

Step-by-step implant placement

22

One-stage surgical protocol

26

Two-stage surgical protocol

27

Step-by-step implant placement, 6 mm

28

Torque Wrench – surgical handling

30

Torque guide

32

Cleaning and sterilization

33

This manual is designed for use by clinicians who have undergone at least basic surgical and in-clinic implant training. Staying current on the latest trends and treatment techniques in implant dentistry through continued education is the responsibility of the clinician. All products may not be regulatory cleared/released/licensed in all markets. Please, contact the local Dentsply Sirona sales office for current product assortment and availability. To improve readability for our customers, Dentsply Sirona does not use ® or ™ in body copy. However, Dentsply Sirona does not waive any right to the trademark and nothing herein shall be interpreted to the contrary. Product illustrations are not to scale.

3

Introduction

Drilling protocol The density and orientation of trabeculae in spongious bone differs from patient to patient and from location to location. These variations can create differences in perceived resistance when preparing the implant site and installing the implant. The marginal cortical bone, however, is most often homogeneous in quality but may vary in thickness from case to case, which requires a mandatory adaptive preparation method.

Thin cortical bone (less than 2 mm)

A unique drilling protocol has been developed to allow for preferred primary implant stability. The strategy with the drilling protocol is to provide apical bone support to the implant when indicated, but relieve the apex from bone contact when this support is not indicated.

Spongious bone

The stepped osteotomy, providing apical bone support for the implant, is indicated in soft bone situations. In other situations the apical portion of the osteotomy can be widened using the V- or X-drill. The X-drill also widens the body portion of the osteotomy and is indicated in more dense bone situations e.g. in the lower jaw.

Thick cortical bone

Implant assortment

OsseoSpeed® EV Straight

OsseoSpeed EV implants are available in a versatile range of shapes, diameters and lengths for all indications, including situations with limited space and/or bone quantity. Specific colors have been assigned to the different implant-abutment connection sizes, which are consistently used throughout the system and identified by symbols and colors.

OsseoSpeed® Profile EV For additional information on OsseoSpeed Profile EV, please refer to the OsseoSpeed Profile EV manual/ product catalog.

4

Conical

Ø 3.0

Ø 3.6

Ø 4.2

Ø 4.8

Ø 5.4

Green

Purple

Yellow

Blue

Brown

OsseoSpeed® Profile EV Straight

Conical

Ø 4.2

Ø 4.8

Yellow

Blue

Introduction

Implant size/tooth position The design philosophy of the Astra Tech Implant System EV is based on the natural dentition utilizing a site-specific, crown-down approach supported by an intuitive surgical protocol and a simple prosthetic workflow.

Implant-abutment interface connection The OsseoSpeed EV implant has a unique interface with a one-position-only placement for restorative procedures and components, e.g. the Atlantis patientspecific abutments. The interface also allows for the flexibility of six-position indexing of prefabricated abutments, while index-free abutments can be seated in any rotational position.

OsseoSpeed EV

Abutment placement option One-position-only Atlantis patient-specific, abutments will seat in one position only.

Six positions Indexed abutments will seat in six available positions.

Multiple considerations are required for each tooth replacement, the support needed for the final restoration in the particular position, soft-tissue healing, and implant design and size. The illustration indicates the recommended implant sizes in relation to the natural dentition, provided there is sufficient bone volume and space in relation to adjacent dentition.

Index free Index-free abutments will be seated in any rotational position.

5

Introduction

Tray concept The tray layout and components are organized to support the user throughout the entire surgical procedure. The tray design eliminates the need for rubber grommets for holding drills and instruments, which simplifies the cleaning process. The layout is printed on the overlay, which is snapped onto the tray base. This solution offers the possibility of adapting the tray’s contents according to individual preferences.

Lid

Overlay

Tray base

Tray logics The color-coded, large tray has a drill marking system for ease of use and effective handling throughout the procedure, based on the following principles: ■■

■■

■■

■■

 rills for the spongious bone preparation are colorD coded white and marked with drill numbers 1–6 on the drill shaft.  rills for the mandatory cortical bone preparation are D color-coded according to the implant and marked with either an A or B for straight implants or A/B for conical implants.  rills for relieving the apical bone support and D widening of the osteotomy are color-coded according to the implant and marked with V or X. In addition to the diameter, all drills shafts are marked with a number or letter for easy identification and reference.

Cortical bone preparation – straight implants

Spongious bone preparation

1

6

Base shield

2

3

4

5

6

A

B

A

A

B

A-6 mm

B

B-6 mm

Cortical bone preparation – conical implants

A

Spongious bone preparation

B

A/ B

V

X

Introduction

Overlay 1

Streamlined content for the most commonly used straight implants.

Overlay 2

Designed to accommodate the complete range of diameters for straight and conical implants.

Overlay 3

Supports the full implant assortment including short and OsseoSpeed Profile EV implants.

Small Tray EV A flexible, compact and convenient small tray available in three layout options: surgical, restorative and storage.

7

Introduction

Color coding Throughout the Astra Tech Implant System EV, markings, color coding and geometrical designs simplify the correct identification of corresponding components.

Ø 3.0

Ø 3.6

Ø 4.2

Ø 4.8

Ø 5.4

Each implant-abutment connection size is identified by a specific color, which is used consistently throughout the system. The color is applied directly to components and instruments, as well as on packaging and informational material, where appropriate.

Green

Purple

Yellow

Blue

Brown

The following components and/or packaging are color-coded:

Healing components

Abutment screws for all two-piece abutments

Packaging for components on implant-level

Laboratory components on implant-level

Impression components on implant-level

8

Treatment planning

Pre-operative procedures Pre-operative examination An evaluation of the patient’s general and oral health, with clinical and radiographic examinations, must be performed. Particular attention should be given to mucous membranes, jaw morphology, dental and prosthetic history, and signs of oral dysfunction.

Simplant computer guided implant treatment software can be used for the Astra Tech Implant System EV to ensure accurate planning for optimized implant position and placement.

Radiographic analysis should be used to evaluate bone topography of the residual alveolar process. The initial radiographic evaluation, together with the clinical examination, is the basis for determining whether or not a patient is a candidate for implant treatment.

Even though the final treatment approach may be determined at the time of surgery, consider the following based on the quality of supporting bone and expected initial stability of the implant(s):

If the patient is found to be suitable, a more thorough clinical examination of the area for treatment and the opposing jaw should be performed. Any local pathology in the jaws should be treated before implant placement.

Pre-operative planning

„„

One- or two-stage surgical procedure

„„

Immediate or early loading protocol

„„

Expected healing time before loading

When the prerequisites for immediate loading cannot be met, an early loading protocol (at least six weeks healing period) may be considered.

Pre-operative planning should be based on the expected restorative treatment outcome. The Astra Tech Implant System EV assortment is designed to meet the prosthetic needs for the tooth replacement planned. The prosthetic versatility in materials, designs and sizes is aligned with the implant for support of the tooth replacements in the different positions in the jaw.

In all situations, bone quality and quantity, primary stability achieved, design of restoration, and loading conditions should be carefully examined and assessed by the clinician when determining time to loading of implants for each individual case.

To achieve the expected outcome, treatment planning should include all stages of the procedure, from healing time and components to provisional and final restorations.

Before treatment begins, the patient should be informed about the results of the pre-operative examination and given a clear explanation of what is entailed by the planned treatment, including the expected outcome, maintenance requirements and risks involved.

Today, digital processes with CBCT scans, together with optical surface scans, can replace or complement models mounted on an articulator and provide (analog or virtual) information of the relationship between jaws and teeth. A diagnostic wax-up with the missing teeth replaced provides important information in the planning phase. Based on analysis and evaluation of the occlusal table, force distribution and preferred sites for the implants, an optimal plan can be achieved. The transparent Radiographic Implant Guides displaying implants in different magnifications are helpful in planning optimal position, direction and implant size. When working in a digital environment, the planning software provides a library of the different implants.

Radiographic Implant Guides

9

Treatment planning

Clinical application OsseoSpeed EV implants are indicated for immediate placement in extraction sites and/or in partially or completely healed alveolar ridges using a one- or two-stage surgical procedure. Implants with the OsseoSpeed surface are especially indicated for use in soft bone situations where implants with other surface treatments may be less effective.

Implant shape

General clinical application

Straight

Suitable in the majority of situations.

For replacement of maxillary lateral and mandibular central and lateral incisors when there is not enough space for a wider implant.

Used in situations with limited bone volume or space between adjacent teeth, where a 4.2 mm implant is judged to be too wide.

Conical

In situations with limited bone volume where a larger prosthetic platform is preferred.

N/A

N/A

Precaution: When treatment planning for implant with 6 mm length consider the widest possible implant, a two-stage surgical approach and splinting of implants. Closely monitor the patient for peri-implant bone loss or change in the implants’ response to percussion. If the implant shows greater than 50% bone loss or mobility, consider possible removal of implant.

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OsseoSpeed EV implants can be used in an immediate loading protocol. However, for single-tooth replacement in soft bone or when using a 6 mm implant, where primary implant stability may be difficult to maintain, immediate loading may not be appropriate and thus not recommended.

Treatment planning

Based on mechanical strength considerations, it is recommended to always place the widest implant possible for the edentulous space. This is particularly important in the posterior regions of the jaws where loading forces are high and considerable bending moments could be generated.

In all cases, it is important to consider loading conditions when determining the number and spacing of implants.

Suitable in the majority of situations.

Used in situations with enough bone volume.

Suitable in situations with wide ridges and large edentulous spaces.

Suitable in situations with limited bone volume where a 3.6 mm implant ­diameter is the choice but where a larger prosthetic platform is preferred.

Suitable in situations with bone volume where a 4.2 mm implant diameter is the choice but where a larger prosthetic platform is preferred.

N/A

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Implant site preparation

Surgical components and instruments overview Implant sites are prepared in a step-by-step procedure using different diameter drills, instruments and verification tools, ensuring an efficient and atraumatic preparation. All drilling in the bone should be performed at a maximum of 1500 rpm using profuse external irrigation with a saline solution. An intermittent drilling technique will help prevent heating of the bone and create a pumping effect for efficient removal of bone tissue.

■■

Excellent cutting properties

■■

Laser-etched depth indication lines

■■

Sterile packaging

■■

Multiple-use* with option for single-use

■■

■■

In addition to the diameter, all drills shafts are marked with a number/letter for easy identification and reference Color-coded

Packaging

Pick-up

Guide Drill EV / Precision Drill EV

■■ Open the package.

■■ Engage the drill with the contra angle.

Used for marking and creating a starting point.

■■ Pour the blister onto a sterile area. ■■ Secure the drill by squeezing the blister. ■■ Expose the drill shaft by bending back

the top of the blister.

* All drills except Precision Drill EV can be used for approximately ten cases. They should be carefully cleaned and sterilized after each surgery and replaced as soon as a decrease in their cutting efficiency is observed.

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Astra Tech Implant System EV drills:

Note: The Precision Drill EV is an extremely sharp, single-use-only drill and should never be handled manually once out of its package.

Implant site preparation

Drill packaging*

*Patent pending

B A B

1

2

3

4

5

A

6

Spongious bone preparation

Cortical bone preparation – straight implants

Cortical bone preparation – conical implants

Twist Drill: Used for initial preparation and evaluation of the bone 1 .

Mandatory preparation of the cortical layer to reduce pressure in the bone around the implant neck.

Mandatory preparation of the cortical layer to reduce pressure in the bone around the implant neck.

■■ Color: corresponds to implant

Apical border of the indication line indicates the minimum depth needed to fit the implant. A In thin cortex, drill to the apical border of the depth indication line. B In thick cortex, drill to the full depth of the depth indication line. Make sure enough depth is provided for the entire implant.

Step Drill: Used for site preparation, resulting in a stepped osteotomy with apical bone support for the implant. The drills 2 – 6 provide guidance during the drilling process. ■■ Color: white ■■ Markings: diameter and drill number ■■ Length: available in short (6–13 mm)

and long (6–17 mm)

■■ Markings: diameter and drill letter ■■

A – thin cortical bone < 2 mm

■■

B – thick cortical bone ≥ 2 mm

■■ Length: one option

Note: There are separate cortical drills specific for the 6 mm implant.

■■ Color: corresponds to implant

A

B

6 mm

6 mm

■■ Markings: diameter and drill letter ■■ Length: one option

13

Implant site preparation

Surgical components and instruments overview

6 mm

3.0 mm

6 mm

Alternative spongious bone preparation

Direction Indicator EV

V-Twist Drill – extra apical preparation

X-Step Drill – extra body preparation

Following the opening of the marginal cortical layer with cortical drill A , B or conical drill A/B , the V drill is used to relieve the apical bone support when this support is not indicated.

Following the opening of the marginal cortical layer with cortical drill B or conical drill A/B , the X drill, in addition to relieving the apical bone support, is used to widen the body portion of the osteotomy in situations with more dense bone e.g. the lower jaw.

■■ Color: corresponds to implant

Note: for conical implants, this color refers to the implant body diameter. ■■ Markings: diameter and

V

■■ Length: a  vailable in short (6 –13 mm)

and long (6 –17 mm).

■■ Color: corresponds to implant

Note: for conical implants, this color refers to the implant body diameter. ■■ Markings: diameter and

X

■■ Length: a  vailable in short (6 –13 mm)

and long (6 –17 mm).

14

5.4 mm

Used for visualizing the position and direction of the prepared osteotomy. The narrow end is used after drill 1 and the wider end is used after drill 3 . A laser marking indicates the 6 mm depth. The flange (collar) of the instrument indicates the smallest (3.0) and greatest (5.4) implant platform size. Direction Indicator EV is equipped with a hole for attaching a safety thread.

Implant site preparation

Measuring osteotomy depth Carefully measure the depth of the osteotomy. Use the same clinical reference point for the depth as for the planned implant position. The depth should allow the implant to be level with or slightly submerged in relation to the adjacent marginal bone.

17 mm 15 mm 13 mm

Drilling depth

11 mm 9 mm 8 mm

The drilling depth is measured from the widest part of the drill tip up to the indication line. Length, available in short (6–13 mm) and long (6 –17 mm).

6 mm

Additional tip depth is maximum 1.0 mm regardless of the drill diameter.

+1 mm

6 mm 5 mm 4 mm 3 mm 2 mm

4.8-

3.6-

5.4-

0 mm

Implant Driver Extender EV-GS

Implant Depth Gauge EV

Implant Driver EV

Used for extending the length of a drill shaft.

Used for measuring the depth of the implant site. ■■ Markings: corresponds to the implant lengths 6–17 mm

Used for picking up and installing the implant in the prepared osteotomy. The Implant Driver EV can engage into any of the six positions of the implant. The body of the driver has a hexagonal geometry with dimples. Note: To facilitate optimal placement of pre-designed abutments, align one of the dimples buccally.

Note: Ensure sufficient irrigation when using the drill extension.

The other end of the gauge can be used as a measuring probe. ■■ Markings: 0–15 mm

Note: The depth gauge is designed with waist to facilitate the identification of the 13–15 mm marking.

The reference point (“0”) of the depth markings is the intended bone level, i.e., the lowest point of the bevel. ■■ Color: corresponds to implant ■■ Markings: depth and diameter ■■ Length: two options

15

Implant site preparation

Implant packaging and handling The packaging includes a 2D barcode for simplified inventory control.

Packaging

Implant container

Implant pick up

■■ Packages contain protective blisters that

■■ Open the blister package.

■■ Attach the appropriate

hold the components.

■■ Pour the sterile inner container onto a

sterile area.

Labels ■■ Three peel-off labels are provided for

the patient’s treatment record and for communicating with the restorative team.

16

■■ Remove the cap from the container

using a twisting motion to expose the top of the implant. Note: Marked with implant size and length

Implant Driver EV to the contra angle or Surgical Driver Handle.

Implant site preparation

a)

b)

Implant pick up

Attach the Implant Driver EV

Manual implant pick up

■■ Make sure that the implant driver is fully

■■ Attach the Implant Driver EV by pressing

■■ Use the Implant Driver EV together with

seated into the implant (a). ■■ Press downwards to activate the carrying

function before picking up the implant (b). ■■ When picking up the implant from the

it firmly into the Surgical Driver Handle EV. The driver is correctly seated when the color coded marking is just in contact with the handle.

Surgical Driver Handle EV to pick up the implant.

inner container, do not use excessive pressure.

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Implant site preparation

Drilling protocol for OsseoSpeed® EV – straight A 1

2

A -Cortical Drill EV Ø2.5/2.7

1 -Twist Drill EV Ø1.9 2 -Step Drill EV Ø1.9/2.5

B

V -Twist Drill EV Ø2.5

B -Cortical Drill EV Ø2.5/3.0

X -Step Drill EV Ø2.5/2.85

A 1

3

A -Cortical Drill EV Ø3.1/3.3

1 -Twist Drill EV Ø1.9 3 -Step Drill EV Ø2.5/3.1

B

V -Twist Drill EV Ø3.1

B -Cortical Drill EV Ø3.1/3.6

X -Step Drill EV Ø3.1/3.45

A 1

3

4

A -Cortical Drill EV Ø3.7/3.9

1 -Twist Drill EV Ø1.9

Guide Drill EV Precision Drill EV

B

V -Twist Drill EV Ø3.7

3 -Step Drill EV Ø2.5/3.1 4 -Step Drill EV Ø3.1/3.7

B -Cortical Drill EV Ø3.7/4.2

X -Step Drill EV Ø3.7/4.05

A 1

3

5

A -Cortical Drill EV Ø4.3/4.5

1 -Twist Drill EV Ø1.9 3 -Step Drill EV Ø2.5/3.1

B

5 -Step Drill EV Ø3.7/4.3

V -Twist Drill EV Ø4.3

B -Cortical Drill EV Ø4.3/4.8

X -Step Drill EV Ø4.3/4.65

A 1

3

5

6

1 -Twist Drill EV Ø1.9

A -Cortical Drill EV Ø4.9/5.1

B

V -Twist Drill EV Ø4.9

3 -Step Drill EV Ø2.5/3.1 5 -Step Drill EV Ø3.7/4.3

B -Cortical Drill EV Ø4.9/5.4

6 -Step Drill EV Ø4.3/4.9

Note: There are separate cortical drills specific for the 6 mm implant.

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X -Step Drill EV Ø4.9/5.25

Implant site preparation

Drilling protocol for OsseoSpeed® EV – conical Conical implants are available for situations with limited bone volume where a diameter 3.6 or 4.2 mm implant body is the choice, but where a larger prosthetic platform is preferred. Note: If an additonal spongious bone preparation with V or X drill is performed, use the color that refers to the implant body diameter.

1

V -Twist Drill EV Ø3.1

3

1 -Twist Drill EV Ø1.9

A/ B -Conical Drill EV Ø3.1/4.2

X -Step Drill EV Ø3.1/3.45

3 -Step Drill EV Ø2.5/3.1

Note: for conical implants, color refers to the implant body diameter

Guide Drill EV Precision Drill EV

1

3

V -Twist Drill EV Ø3.7

4

1 -Twist Drill EV Ø1.9

A/ B -Conical Drill EV Ø3.7/4.8

X -Step Drill EV Ø3.7/4.05

3 -Step Drill EV Ø2.5/3.1 4 -Step Drill EV Ø3.1/3.7

Note: for conical implants, color refers to the implant body diameter

19

Implant site preparation

Expanded drilling protocol for OsseoSpeed® EV – straight OsseoSpeed® EV – conical In sites with compromised bone, the drilling protocol can be expanded to provide further guidance with more drilling steps. This approach is particularly useful in situations with an extremely narrow alveolar ridge (knife-edge).

OsseoSpeed® EV – straight

20

1

2

1

2

OsseoSpeed® EV – conical

A B

3

A

4.2

1

2

3

4.8

1

2

3

4

B Note: for conical implants, color refers to the implant body diameter

A

1

2

3

4

1

2

3

4

5

1

2

3

4

5

B A B

6