XiVE Surgical Manual

Implantology Unlimited For more than a decade, the XiVE implant system has provided full restorative options. From the narrowest gap to the fully atrophied edentulous jaw, in hard or soft bone, from singlestage to two-stage protocols, from subgingival to transgingival healing, from immediate to delayed loading – with XiVE, you decide which treatment concept to select. The basis for this freedom of choice, both surgically and prosthetically, is the combination of some outstanding XiVE features and benefits. This is why implant professionals all over the world appreciate Implantology Unlimited with XiVE.

Please read this manual carefully before using the system for the first time and observe the directions and notes in the instructions for use of the system components and instruments at all times. We also recommend that all users attend a training course in the system before using a new implant system for the first time.

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CONTENTS System concept Comprehensive implant selection Bone-specific preparation protocol Prosthetic versatility

5 9 10

Treatment planning Aspects of treatment planning Conventional treatment planning Computer-guided treatment planning

12 14 17

Implant site preparation Rotary preparation XiVE surgical kits XiVE instrument set Step-by-step: Preparation with twist drills

18 20 28

Mechanical preparation (osteotomy) XiVE instrument set Step-by-step: Sinus floor elevation with XiVE BoneCondensers

34 36

Implant placement and restoration XiVE S Implant packaging FRIADENT TempBase XiVE S instrument set Step-by-step: XiVE S implant placement Step-by-step: Submerged healing Step-by-step: Index impression Step-by-step: Transgingival healing with temporary denture Step-by-step: Temporary restoration of multiple implant placements Step-by-step: Transgingival healing with gingiva former

38 40 42 44 48 50 53 56 58

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concept

System 4

Indications • Edentulous spans • Free-end edentulism • Edentulous jaw

Prosthetic concept • Single-tooth replacement • Fixing bridges and prostheses • XiVE D 3.0: single-tooth replacement in the front tooth region and splinted single-tooth restorations

Type of prosthetic restoration • Two-stage procedure • Non-functional immediate loading • Functional immediate restoration with splinting of four screw implants in the mandible (not XiVE D 3.0)

Time of implant placement • Immediate implant placement • Delayed immediate implant placement • Late implant placement

Comprehensive implant selection XiVE® implant diameters and lengths

Color-coding

The narrowest gap or edentulous jaw, hard or soft bone, single-session or two-session, immediate loading or delayed loading – with the comprehensive range of implants from 3.0 mm up to 5.5 mm diameter and 8 mm up to 18 mm length, the bone-specific preparation protocol and wide range of prosthetic options available with the system, which is appreciated by dental technicians all over the world, XiVE helps you achieve an outstanding safe and predictable result in every case.

A separate color is allocated to every XiVE implant diameter, and it can be found on all implant packages, instruments and prosthetic components. The color-coding makes it easy to identify the diameter and select the right prosthetic components without danger of confusion.

XiVE implants adapt to variations in jaw anatomy with a wide range of diameters and lengths that combine with the cylindrical implant body to make optimum use of the available bone volume in even anatomically complex situations. In many cases additional grafting procedures are unnecessary. Besides the subgingival XiVE S cylindrical screw implants, the XiVE implant range includes the option of transgingival XiVE TG implants. The endosseous section of both types of implants is identical, which means that preparation for both types uses the same instruments and the type of implant can be decided during the surgical procedure.

D 3.0

D 3.4

D 3.8

D 4.5

D 5.5

Bronze

Silver

Yellow

Blue

Red

3.0 mm

3.4 mm

3.8 mm

4.5 mm

5.5 mm

Lengths

–

–

8 mm

8 mm

8 mm

–

9.5 mm

9.5 mm

9.5 mm

9.5 mm

11 mm

11 mm

11 mm

11 mm

11 mm

13 mm

13 mm

13 mm

13 mm

13 mm

15 mm

15 mm

15 mm

15 mm

15 mm

–

18 mm

18 mm

18 mm

–

XiVE S

Diameter

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System concept

Comprehensive implant selection Endosseous XiVE® implant design The XiVE implant design with the combination of a cylindrical implant body and special thread design guarantees safe and atraumatic implant placement, even in cortical bone. Superior primary stability can be achieved in all bone qualities. The patented specific thread design with a condensing crestal section is a component of the bonespecific XiVE preparation protocol (see page 9). • Crestal: expanded cylindrical implant body with condensing thread section • Apical: self-tapping thread with apically increasing thread depth

1 | Unique thread design for atraumatic placement and high primary stability.

1

The extension of the implant shoulder tightly seals the cervical gap between bone and implant and makes it easy to place the prosthetic components.

2 | (Micro)extended implant shoulder for a dense cervical contact between bone and implant.

Friction

Condensation

Tapping

XiVE S screw implants with self-cutting threads and core design for internal condensation.

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2

System concept

Trimodal XiVE® implant surface A strong bone-implant interface shielded from damaging intraoral influences by a soft-tissue collar is essential for the long-term success rate of implants. The three-section hybrid surface of XiVE implants with the FRIADENT plus surface in the endosseous section is the basis for optimum integration of the implant body.

Endosseous section with FRIADENT plus surface • Favors stable adhesion of bone-forming cells • Induces intensive bone formation from the earliest stages of osseo-integration • Ensures high primary stability and allows early functional loading of implants

2 | Initial contact and anchorage of an osteoblast by threadlike extensions (filopodia) on the FRIADENT plus surface.

3 | Cells on the FRIADENT plus surface form typical, widespread multifocal contacts that are interconnected and extend the pores over long distances. The cell chains consist of three to six cells, each approx. 30 μm long.

4 | Section of the thread of a XiVE implant (20x magnification). Homogenous bone margin (red) between the implant threads.

1

2

3

(fig. 2 and 3: R. Sammons et al.)

Acid-etched section • Promotes deposition of subepithelial connective tissue • Makes it easier to reach the planned implant position in uneven bone, because bone-forming cells and soft-tissue cells both form on the implant

1 | Trimodal implant surface.

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(fig. 4: Prof. Dr. A. Piattelli, Chieti/I.)

Structure-polished implant collar • Perfect soft-tissue adaptation with dense deposition of epithelium on the implant • Protection of the underlying tissue from mechanical and microbial irritation

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System concept

Comprehensive implant selection XiVE® implant-abutment connection The deep, internal XiVE S implant-abutment connection with internal hex locks the prosthetic components in the implant by transferring laterally acting forces directly from the internal geometry of the implant via the abutment.

XiVE® S: deep, internal hexagonal connection •C  lear and accurate positioning of the abutment with six reversible positioning options •R  otation lock by internal hex •S  tability with 3.5 mm deep parallel guide surfaces in the implant and wide plateau on the implant face •R  estoration with prosthetic components from the FRIADENT range of prosthetic components The FRIADENT abutment screw locks the abutment in the implant and is not exposed to any horizontal stresses. This effectively prevents screws from loosening and breakage.

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System concept

Bone-specific preparation protocol XiVE® condensing implant design

The bone quality in the maxilla and the mandible may vary greatly depending on the area of the jaw. By varying the preparation of the crestal section of the implant site depending on the bone quality in combination with the condensing implant design, XiVE achieves excellent primary stability in all bone qualities – atraumatic and gentle in hard bone of density D I, stable and secure in soft bone of density D IV.

The special design of XiVE implants condenses the periimplant bone during implant placement in cancellous bone without requiring the assistance of additional instruments (see page 6). This principle of internal condensation achieves excellent primary stability and means that the implant is securely fixed even in very soft or reduced bone quality.

Bone-quality-oriented XiVE® implant site preparation

Atraumatic XiVE® implant placement

1

2

3

1 | The depth of crestal preparation in D I to D III bone is 6 mm.

2 | In particularly dense bone the tap is also used.

3 | The depth of crestal preparation in D IV bone is 2 mm.

4

60 50 40 30 20 10 0

Implant placement in cortical bone is safe and atraumatic with the apically self-tapping XiVE thread. Tapping the crestal implant site during implant placement with this thread prevents stress and overheating, particularly in the physiologically less reactive cortical bone. For detailed instructions on preparation of the implant site see page 19 ff.

Standard screw implant XiVE

0

2

4

6

Torque in in Ncm

2 mm

Torque in in Ncm

Once the site has the required implant diameter, the next step is generally crestal preparation of the bone to adapt it to the clinical situation. Here the drilling depth of the crestal drill is varied depending on the bone density, and in harder bone quality the tap is also used. This preparation is always required unless there is no cortical bone. The preparation of the cavity to adapt it for the bone density ensures ideal conditions for not loading the cortical bone during placement of XiVE screw implants.

8 10 12

Countersink depth in mm

4 | Torque stabilization of XiVE(red) in bone quality D I; the platform formation guarantees an atraumatic placement.

5

60 50 40 30 20 10 0

XiVE

0

2

4

6

Standard screw implant

8 10 12

Countersink depth in mm

5 | Torque stabilization of XiVE (red) in bone quality D IV by internal condensation.

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System concept

Prosthetic versatility FRIADENT® TempBase concept The unique TempBase concept for XIVE allows immediate restoration with a high-quality temporary denture in many cases. Immediate loading of the implants is also possible under suitable conditions. The multifunctional FRIADENT TempBase is premounted as an placement head on all XiVE S implants. It is also designed to be used as a provisional abutment to which a temporary restoration can be attached without changing components – i.e. without additional risk.

With submerged healing • Index impression with TempBase Cap immediately after implant surgery •M  anufacture of a high-quality, accurately fitted temporary denture in the laboratory for delivery immediately after implant uncovery

With a single-stage procedure • F abrication of a high-quality implant-supported temporary denture with TempBase Cap in the chairside immediately after placement

(Photos Jan Kielhorn, Öhringen/D)

For detailed instructions on the application of FRIADENT TempBase see page 40 ff.

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1

2

1 | Insertion of the XiVE implant with color-coded FRIADENT TempBase.

2 | The pre-fabricated FRIADENT TempBase Cap as the base for the temporary denture.

3 3 | Non-functional immediate loading with a temporary crown.

System concept

XiVE® prosthetic options FRIADENT prosthetics have been setting new standards in the dental practice and dental laboratory for almost 20 years. The range is clearly classified and color-coded throughout. The patented, deep internal hex connection between implant and abutment enables a secure connection and minimizes micromovements between implant and abutment.

XiVE® S prosthetic restoration A wide range of prefabricated components for prosthetic restoration on XiVE S implants in even the most demanding cases is available in the FRIADENT prosthetics range – in the implant diameters, various gingival heights, straight and angled. XiVE S

Single toothcrowns

Fixed bridges

Removable denture

FRIADENT Esthetic Base

x

x

–

FRIADENT CERCON Abutment

x1

–

–

FRIADENT CeraBase

x2

–

–

FRIADENT AuroBase

x

x

FRIADENT MP Abutments

–

x

FRIADENT Ball Attachment

–

–

x2,3

FRIADENT Telescopic Abutment

x

–

x

x 2

x2

Single-tooth restoration in front-tooth region only (region 13–23 and 33–43), available in D 3.8 and D 4.5 only. Not available for D 3.0. 3 In the edentulous mandible only on at least two implants interforaminally. 1

2

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planning

Treatment 12

Aspects of treatment planning The treatment planning is based on a comprehensive consultation with the patient, which is used to determine exactly what the patient wants and expects from the treatment, discover any possible contraindications and to explain the treatment in detail to the patient. It is followed by a complete general and specific medical history and intraoral diagnosis with analysis of the initial anatomical situation. The following points must be considered: • Medical history • General diagnosis – exclusion of contraindications • Specialist consultation for risk factors • Detailed intraoral diagnosis (PAR diagnosis, functional examination, reasons for tooth loss, evaluation of the old denture, general radiology examination) The treatment plan can be prepared after examination and evaluation of all diagnostic documentation. The plan will include the following: • Preprosthetic planning • Surgical planning • Schedule • Cost schedule

Accurate planning of every implantological procedure is essential for the long-term success of implant treatment. The planning process defines all actions and lists alternatives that can meet the patient‘s expectations of the function and esthetics of the implant-prosthetic rehabilitation.

Indications specially for XiVE® S The two-component XiVE S implants allow submerged healing or a single-session procedure, possibly with fabrication of a high-quality temporary denture with the XiVE TempBase at the time of implant placement. XiVE S is ideal in situations such as: • Where the interalveolar volume is limited: smallest implant diameter D 3.0 • Temporary and definitive components are wanted for a simple and fast prosthetic restoration • All prosthetic restorations options are to be left open • Anatomically adapted diameters are to be selected

Single-tooth restoration in the mandible with a subgingival XiVE S Implant.

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Treatment planning

Conventional treatment planning Preprosthetic planning Preprosthetic planning with the dental technician is the most important factor for the esthetic and functional success of the implant procedure. The target is the best possible, toothanalog placement of the implants. During the first planning session with the patient situation impressions are made to be used as the base for laboratoryfabricated diagnostic aids.

Diagnostic wax-up.

A diagnostic wax-up of the planned prosthetic restoration is made. A thermoformed splint with radiographic balls that can be accurately repositioned in the patient‘s mouth is prepared. It can be subsequently modified to a conventionally fabricated surgical template. The preprosthetic planning is simplified with the FRIADENT Select components.

Contraindications The general contraindications for dental and surgical procedures must be taken into account when selecting patients. They include: •R  educed blood clotting such as anticoagulant therapy, congenital or acquired clotting disorders •P  roblems with wound healing or bone regeneration such as uncontrolled diabetes mellitus, tobacco, drug and alcohol abuse, metabolic diseases that could affect wound healing and bone regeneration • Immunosuppressive therapy such as chemotherapy and radiotherapy • Infections and inflammations in the oral cavity such as periodontitis, gingivitis

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Thermoformed splint with radiographic balls.

• Untreated parafunctional disorders such as bruxism • Poor oral hygiene • Lack of motivation for total oral rehabilitation • Poor occlusion and/or articulation and inadequate interocclusal distance • Insufficient bone volume or soft tissue coverage

Side effects The following side effects of surgical procedures may include: • Temporary local swelling, edema, hematoma • Temporary restriction of sensitivity and chewing function

Treatment planning

FRIADENT® Select try-in abutments FRIADENT Select try-in abutments make selection of the optimum implant diameter much easier. Because the dimensions of the try-in abutments match those of the subsequent crown abutments, the oro-vestibular and the mesiodistal position and the distance to adjacent implants or teeth can be measured on the planning model and checked during surgery after the pilot hole has been drilled and modified if necessary. FRIADENT Select try-in abutments can also be used with the XiVE S implant and the associated implant analog.

FRIADENT Select try-in abutments: • Available in diameters D 3.0 – D 5.5 in straight form • Also available in angled form (D 3.0 to D 3.8) for checking angulation • Step marks corresponding to gingival margins GH 1, GH 2, GH 3 • Groove marks for total occlusal height • Drilled holes matching GH 2 for determining the position of the horizontal retaining screw • Determines the implant position and the position of the horizontal implant clearance • Checks the oro-vestibular and the mesio-distal position • Determines the gingival margin and the position of the horizontal screw

Holder

GH 3 GH 2 GH 1

GH 3 GH 2 GH 1

Groove marks for reading the height (depends on the gingival margin) Threaded hole to indicate the position for the horizontal screw (GH 2) and hex, fixation of the safety floss during surgery

Step marker to show gingival margin

2.0 mm pin for insertion into the pilot hole 1.0 mm pin section allows seating in the implant and implant analog

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Treatment planning

Conventional treatment planning Surgical planning During preoperative planning it is very important to check that the height and width of the jawbone is sufficient for placement of the implant.

Fabrication of the surgical template The surgical template, which is used to transfer the preprosthetic planning to the clinical situation, is fabricated on completion of the surgical and prosthetic treatment planning. The correct seating of the surgical template must be checked in the oral cavity. The width of the vestibular and oral lamellae should be at least 1.5 mm. The position and direction of important anatomical structures such as the mental foramen or maxillary sinus must be determined by radiology. Grafted regions must be confirmed to have completely regenerated to a mechanically stable state before preparation. Planned prosthetic measures must be checked to ensure that they can actually be implemented with reasonable surgical procedures. All aspects of preprosthetic and surgical planning interact directly with one another. Every change in the preprosthetic planning will affect the surgical planning and vice versa. This will also include the number, diameter, lengths, position and alignment of the implants. The available bone volume and important anatomical structures are examined in an radiographic image, which is prepared with the laboratory-fabricated radiographic template with the radiographic balls in the patient‘s mouth. The dimensions inside the oral cavity can be calculated accurately from the defined diameter of the radiographic balls. The implant lengths are selected by placing the transparent XiVE x-ray template on the OPG.

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XiVE radiographic template.

Treatment planning

FRIADENT® Select sleeves The FRIADENT Select sleeves, which are integrated in the surgical template, are used to transfer the preprosthetic planning exactly to the clinical situation. The sleeve that corresponds to the implant diameter indicates the implant center, the FRIADENT Select guide pin, which is fixed in the central internal hole, shows the direction of the implant hole. The crestal implant center is marked with the D 2.0 twist drill during the pilot drilling. Prosthetic diameter Retention groove Implant diameter

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preparation

Implant site 18

XiVE® surgical kits All instruments for surgical use of the XiVE implant system are stored in XiVE surgical kits, which are designed to make all instruments easily accessible and easy to clean and sterilize. The modular components of the trays with the minimum required number of instruments can be supplemented with additional modules for specific diameters. The light plastic trays with organizers integrated into the cover for holding used instruments define a specific user sequence during surgery. All instruments are securely held in silicone holders. The XiVE surgical manual describes the standard protocol for implant site preparation with XiVE twist drills. If you have decided to use computer-guided treatment planning and preparation, please see page 71. From the chapter “Implant placement and restoration” (see page 38 ff.) the procedures and options for both protocols are similar.

Practical organizer for used instruments The following XiVE surgical kits are available: Removable tray cover for simple handling during surgery

Storage of implant drills in diameter-specific snap-on modules for utmost flexibility Surgical ratchet, implant drivers and screw drivers clearly arranged Base plate for stable fixation of the modules

XiVE Surgical Kit D 3.0 – D 5.5 / S+L: Fully equipped with all instruments required for placement of XiVE implants in diameters of 3.0 – 5.5 mm, including two lengths of twist drills, S (short) and L (long).

XiVE Surgical Kit D 3.0 / S+L: Equipped with all instruments required for placement of XiVE D 3.0 implants including two lengths of twist drills, S (short) and L (long).

XiVE Surgical Kit D 3.0 – D 3.8 / S: Basic kit with all instruments and S (short) twist drills required for placement of XiVE implant in diameters of 3.0 – 3.8 mm.

The trays can be thoroughly and easily cleaned in accordance with ISO 17664 – please follow the instructions in the Cleaning, Care and Sterilization Manual.

For preparation with Guided Surgery a separate surgical kit is available.

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Implant site preparation | Rotary preparation

XiVE® instrument set An essential component of a successful implant placement is accurate and atraumatic preparation of the bone at the implant site. The implant site is prepared for XiVE implants in accordance with the bone class to ensure simple and safe implant placement in all bone qualities.

XiVE S all Implants D 3.0

XiVE S all Implants D 3.4

XiVE S all Implants D 3.8

XiVE S all Implants D 4.5

XiVE S all Implants D 5.5

XiVE Round Drill

XiVE Twist Drill S or L D 2.0

The instrument set for implant site preparation is identical for XiVE S and XiVE TG implants.

XiVE Twist Drill S or L D 3.0

XiVE Twist Drill S or L D 3.4

XiVE Twist Drill S or L D 3.8

XiVE Twist Drill S or L D 4.5

XiVE Twist Drill S or L D 5.5

XiVE Twist Drill crestal D 3.0

XiVE Tap D 3.0

XiVE Twist Drill crestal D 3.4

XiVE Tap D 3.4

XiVE Twist Drill crestal D 3.8

XiVE Tap D 3.8

XiVE Twist Drill crestal D 4.5

XiVE Tap D 4.5

XiVE Twist Drill crestal D 5.5

XiVE Tap D 5.5

All XiVE drills with internal irrigation.

Please note: Cutting instruments should generally be replaced after 20 cycles of use. Blunt or damaged instruments must be replaced immediately. Gentle, thorough disinfection and cleaning of the drills will ensure that they operate at their best. Please observe the instructions in the cleaning manual. The stainless steel cleaning needle is used to check and clean the internal cooling ducts of the drill. After cleaning the internal channels and the outlets for the cooling liquid with this needle the drills are sterilized in the XiVE surgical tray in accordance with the guidelines (see sterilization instructions, instrument care).

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