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PERFECT SURFACE
INTERNAL HEX
PeRFeCt
IMPlant PlaCeMent PrOCeDure
OsteOtOMe PROCEDURES
EXTERNAL HEX
PerFeCT SURFACE
Endopore
Contents
Contents
3 Introduction 4 Product Descriptions Endopore implants with internal connection for one-stage surgery Endopore implants with internal hex for one-stage and two-stage surgery Endopore implants with external hex connection for one-stage and two stage surgery 5 Surgical Instrumentation Endopore Surgical Kit Endopore Osteotome Kit Instrument Care and Sterilization 6 Patient Selection Patient Records and Selection Implant Indications Contraindications 7 Pre-Surgical Considerations 8 One-Stage and Two-Stage Implant Placement Procedure Steps 1 to 5 10 Endopore implants with Internal Connection, One-Stage Implant Placement Procedure Steps 6 to 9 11 Endopore implants with Internal Hex and External Hex Connection, Two-Stage Implant Placement Procedure Steps 6 to 9 12 Osteotome Procedures Implant Placement Procedure Using Osteotomes Sequence for Osteotomes Elevating the Sinus Floor During Implant Placement 18 Initial Healing Period and Postoperative Follow-Up Initial Healing Period Implant Loading Two-Stage Re-Entry Surgery 19 Endopore Key Protocol Features for First and Second Stage Surgery
Introduction
Endopore
The purpose of this manual is to describe the surgical protocols for the Endopore Dental Implant System used in a: One-Stage Procedure Two-Stage Procedure Osteotome Procedures
A wide range of prosthetic options is available from Innova for functional and esthetic restorations. Additional options are available from Attachments International, an Innova subsidiary, which has over 25 years of experience in restorative dentistry.
Endopore
Product Descriptions
Product Descriptions
The Endopore Dental Implant is a tapered, truncated titanium alloy cone with a porous surface. The porous surface is achieved by sintering spherical titanium alloy particles to the implant substrate for bone contact and three-dimensional bone ingrowth. Endopore implants, attached cover screws and their associated abutments are supplied sterile. The packaging should be inspected prior to opening. If there is any indication that the package seal is broken, the implant must not be used. Implants must not be re-sterilised.
Abutment Plattform
Length
The Endopore Implant with internal connection is designed with a morse taper and is currently available in both 4.1 mm and 5.0 mm diameters, each having a 4.8 mm wide abutment platform. This allows both the 4.1 mm and the 5.0 mm diameter implants to accept the same prosthetic components. The Endopore implants with internal connection are available in lengths of 5 mm (for the 5.0 mm diameter only),
7, 9 and 12 mm. The machined coronal region of the implant consists of a 0.5 mm smooth collar, and a transgingival region of 1.8 mm high. The Endopore implants with internal connection are packaged with light and dark purple colour coded labels that identify their dia meters. The implants are assembled with a 1.0 mm high cover screw.
Diameter
Length
Endopore implants with internal hex are supplied in both 4.1 mm and 5.0 mm implant diameters and available in lengths of 7 mm, 9 mm und 12 mm. The smooth coronal region
of the implant consists of a 2 mm collar. A low profile cover screw is packaged with each implant.
Diameter
Length
Diameter
The Endopore Implant with external connection is currently available in three diameters: 3.5, 4.1 and 5.0 mm; and four lengths: 5 (for the 5.0 mm diameter only), 7, 9 and 12 mm. The 4.1 mm and 5.0 mm diameter implants are available in a 1 mm or 2 mm smooth coronal region. A low profile cover screw is assembled with each implant. The implants are provided in colour-coded boxes relating to the diameter and the hex style of a particular implant: 3.5 mm diameter implants are packaged in
red labeled boxes. These implants have a 0.9 mm high x 2.0 mm flat-to-flat hex and a UNF thread. 4.1 mm diameter implants with the industry standard hex and threads are packaged in green labeled boxes. These implants have a 0.7 mm high x 2.7 mm flat-to-flat hex and a metric thread. 5.0 mm diameter implants are packaged in turquoise labeled boxes. These implants have a 0.9 mm high x 2.7 mm flat-to-flat hex and a metric thread.
Surgical Instrumentation
Endopore BICORTICAL
Surgical Instrumentation
Endopore Surgical Kit
The basic instrumentation for placing the Endopore Implant consists of: round bur twist drills paralleling pins (occlusal guide pins) colour-coded implant burs colour-coded trial-fit gages stainless steel punch tip straight or offset punch handle drill extension 0.05 hex driver tip wrench mallet
A surgical motor and handpiece with internal and external irrigation capability suitable for implant placement are necessary.
Endopore
Patient Selection
Patient Selection
Patient Records and Selection
Any patient with a fully or partially edentulous mandible or maxilla can be considered for this treatment modality provided that they are in good general health (see Indications and Contraindications). A well-prepared treatment plan is critical for implant success, including but not limited to: C omplete oral examination Treatment of existing pathologies prior to implant placement Radiographic assessment - Good quality panoramic film - Appropriate long-cone periapical films - Additional specialised films for the site(s) being treated: e.g. CT scans Study models A pre-surgical prosthetic guide using the patients prosthesis or natural teeth as a reference so that the implants can be placed in the most suitable locations during the surgery. The clinician must determine all potential risks and the suitability of the patient for an implant supported or implant retained restoration.
Implant Indications
The Endopore Dental Implant is used as an artificial tooth root to support a prosthesis in an edentulous or partially edentulous mandible or maxilla.
Pre-Surgical Considerations
Endopore
Contraindications
Endopore Dental Implants should not be used with patients who have contraindicating systemic or local diseases including, but not limited to:
Local contraindications
Oral infections or malignancies Active periodontal disease
Anatomical contraindications
Insufficient ridge dimensions to accommodate proper implant placement. Ideal ridge width is considered to be 6 mm or more.
Pre-Surgical Considerations
Scaling and root planing one to four weeks before surgery. Pre-operative intra-oral and extra-oral disinfection of the surgical site(s) with chlorhexidine mouthrinse or a similar antiseptic. Isolation of the surgical field with sterile drapes and gowns (OSHA recommendations).
Endopore
Step 2 Use the twist drill at a drill speed of 1000-1500 rpm with copious internal and external sterile saline irrigation. The twist drill is indexed with markings to correspond to the various implant lengths and is used to create a site of the appropriate depth for the implants to be placed.
12 mm 9 mm 7 mm 5 mm
Step 3 A paralleling pin (occlusal guide pin) is used to verify the appropriate alignment with adjacent teeth, opposing occlusion or other implants. A radiographic image is recommended.
Endopore BICORTICAL
Step 4 When the final depth is reached with the twist drill and the paralleling pin confirms the proper angulation, the site is expanded with the appropriate sized implant bur at a drill speed of 1000 rpm with copious internal and external sterile saline irrigation. Exact site preparation is important, especially for tapered, self-seating implants. If a 5.0 mm diameter implant is used, it is recommended to expand the osteotomy gradually by using a 4.1 mm implant bur of the same length, as an intermediate bur. Sharp burs and a high handpiece torque potential are critical to avoid overheating of bone and bur chatter; therefore, it is recommended to change burs after approximately 10 uses, depending on bone density. Surgical gauze fibers can contaminate the surface of the implant and increase the risk of implant failure; therefore, gauze should not be used near the surgical site or on the instruments used in the site preparation.
Step 5 Generously irrigate the osteotomy with sterile saline to remove any bone chips before checking the site with the appropriatesized trial-fit gage. The shoulder of the cone-shaped portion of the gage should be flush with or just below the crestal bone level. The trial-fit gage can be left in the first site as a guide to help achieve parallelism with other implants. For multiple implant sites it is important to ensure that the edge-to-edge interimplant distance is at least 2 to 3 mm to ensure optimal bone and soft tissue (including papilla reformation).
Endopore
Endopore implants with Internal Connection, One-Stage Implant Placement Procedure, Steps 6 to 9
Please note the following steps refer to the Endopore One-Stage implant placement procedure.
Step 6 The implant is carefully removed from the sterile packaging and delivered directly to the site using the attached white delivery tool only. The implant is pressed into the bleeding site with manual pressure and the delivery tool disconnected from the implant using a gentle rocking motion. Care should be taken to avoid inadvertent contact of the porous surface of the implant with anything prior to its full seating into the prepared site. Such contamination could lead to foreign body reaction and failure of the implant to integrate.
10
Step 7 The implant is driven into its final position with several firm taps with the punch tip and mallet, resulting in a tight fit of the implant into the bone. In all cases, the entire porous-surfaced region of the implant and the 0.5 mm smooth coronal region must be fully submerged in bone and the implant must be immobile.
Step 8 The tapping action of seating the implant may loosen the coverscrew; therefore it is important to tighten the cover screw using the 0.05 hex driver and finger pressure. At this point the implant must remain immobile.
Step 9 The flap margins are repositioned and sutured in a tension free manner.
Endopore BICORTICAL
Endopore implants with Internal Hex/External Hex Connection, Two-Stage Implant Placement Procedure, Steps 6 bis 9
Please note the following steps refer to the Endopore Two-Stage implant placement procedure.
Step 6 The implant is carefully removed from the sterile packaging and delivered directly to the site using the attached white delivery tool only. The implant is pressed into the bleeding site with manual pressure and the delivery tool disconnected from the implant using a gentle rocking motion. Care should be taken to avoid inadvertent contact of the porous surface of the implant with anything prior to its full seating into the prepared site. Such contamination could lead to foreign body reaction and failure of the implant to integrate.
Step 7 The implant is driven to its final position with several firm taps with the punch tip and mallet, resulting in a tight fit of the implant into the bone. In all cases, the entire porous-surfaced region of the implant and at least 1 mm of the smooth coronal region must be fully submerged in bone and the implant must be immobile. 11
Step 8 The tapping action of seating the implant may loosen the cover screw; therefore it is important to tighten the cover screw using the 0.05 hex driver and finger pressure. At this point the implant must remain immobile.
Step 9 The flap margins are repositioned and sutured in a tension free manner.
Endopore
Osteotome Procedures
Osteotome Procedures
Implant Placement Procedure Using Osteotomes
With its press-fit design, highly osteocon ductive surface and integration by bone ingrowth and 3-dimensional mechanical interlock, the Endopore Dental Implant is appropriate for placement using osteotome techniques, especially in the posterior maxilla where cancellous bone (Types III & 12 IV bone - Albrektsson and Zarb), i.e., bone of lower density but high vascularity, often predominates. In denser bone in the maxilla (Types I & II) and all sites in the mandible, placement of the implant with surgical burs is necessary.
Step 1 Elevate a full-thickness mucoperiosteal flap to expose the underlying bone. The optimal implant site is marked by perforating the upper bony cortex using a 2.3 mm round bur with the presurgical prosthetic guide at 1500-2000 rpm with copious external saline irrigation.
Step 2 After the cortex has been perforated, the #1 osteotome tip attached to either a straight or offset handle is inserted at the appropriate angulation (for later correct implant orientation) into the marked osteotomy site. The surgical mallet is then used to deliver a series of taps to the end of the osteotome handle taking care to maintain the correct angulation of the osteotome. If the bone is as expected of Type III or IV, the osteotome will quickly advance into the osteotomy, and the development progress of the osteotomy can be measured by observing the osteotome tips depth markings (5, 7, 9 and 12 mm). If a simultaneous sinus floor elevation is being done using osteotomes, please see procedure, pages 13 to 15. If required, an x-ray can be taken at this point to verify the position and proper alignment of the osteotome. To do this, the handle can be unscrewed and removed and the osteotome tip left in situ for the radiograph. If considerable resistance to osteotome advancement is experienced, the twist drill may be required to establish initial partial or complete depth for the osteotomy.
Osteotome Procedures
Endopore BICORTICAL
5 7 9 12
5 7 9 12
5 7 9 12
06-OT1
06-OT2
06M-9TFG/O
4.1 mm 7 mm Length
tip #1
tip #2
tip #3
06-OT1
06-OT2
06-OT3
06-7TFG/O The osteotome tips are labeled as #s 1, 2 and 3 and have increasing tip diameters. All three tips have
4.1 mm 9 mm Length
horizontal markings indicating depths of 5, 7, 9 and 12 mm corresponding to the available Endopore implant lengths. 06-OT1 06-OT2 06-OT3 06-9TFG/O Generally the three tips are used in sequence and once the appropriate depth is reached, the trial-fit gage corresponding to the implant being placed is connected to an osteotome handle and used as the final osteotome.
13
4.1 mm 12 mm Length
06-OT1
06-OT2
06-12TFG/O
06-OT1
06-OT2
06-OT3
06W-5TFG/O
5.0 mm 7 mm Length
06-OT1
06-OT2
06-OT3
06-7TFG/O
06W-7TFG/O
5.0 mm 9 mm Length
06-OT1
06-OT2
06-OT3
06-9TFG/O
06W-9TFG/O
5.0 mm 12 mm Length
06-OT1
06-OT2
06-OT3
06-12TFG/O
06W-12TFG/O
Endopore
Osteotome Procedures
Step 3 After the #1 osteotome tip has reached the required depth for the intended implant length, the procedure is repeated with osteotomes #2 and #3 with the exception of the 3.5 mm x 9 mm and 4.1 mm x 12 mm Endopore. In these instances, only the #1 and #2 osteotomes will be needed for site development (Reference chart on page 13). Pausing occasionally during site development with osteotomes while leaving the osteotomes in the site allows some stress relaxation in the bone and may reduce the risk of fracture of the buccal or palatal cortical plates.
Step 4 When the site depth has been reached with the three (or two in the case of the 3.5 mm x 9 mm and 4.1 mm x 12 mm implant site development) osteotome tips, the appropriate Endopore trial-fit gages* are used as the final osteotome tip. This gage has the exact shape and appropriate dimensions for the implant being placed, i.e., it acts as an implant replica. Note that each Endopore implant has a specific corresponding trial-fit gage found in the Endopore surgical kit, and must be used with the surgical mallet to complete site development. Care should be taken to see that the entire conical tip of the trial-fit gage is seated in bone in order to ensure that the implant later will be seated to the same degree. * As shown in the chart on page 13, if a 5.0 mm diameter implant is being placed, both the 4.1 mm diameter and the 5.0 mm diameter trial-fit gages will be needed to complete the osteotomy. Moving directly from the #3 osteotome tip to the 5.0 mm diameter trial-fit gage is not recommended as this approach could overstress the bone and result in damage to the buccal or palatal cortices.
14
Step 5 The implant is carefully removed from the sterile packaging and delivered directly to the site using the attached white delivery tool only. The implant is pressed into the bleeding site with manual pressure and the delivery tool disconnected from the implant using a gentle rocking motion. Care should be taken to avoid inadvertent contact of the porous surface of the implant with anything prior to its full seating into the prepared site. Such contamination could lead to foreign body reaction and failure of the implant to integrate.
Osteotome Procedures
Endopore BICORTICAL
Step 6 The implant is driven to its final position with several firm taps with the punch tip and mallet, resulting in a tight fit of the implant into the bone. In all cases, the entire porous-surfaced region of the implant must be submerged in bone (around the entire periphery of the implant).
Step 7 The tapping action of seating the implant may loosen the cover screw; therefore it is important to manually tighten the cover screw using the 0.05 hex driver and finger pressure. At this point the implant must remain immobile.
Step 8 The flap margins are repositioned and sutured in a tension free manner.
15
Step 1 Using the appropriate pre-operative radiographs, the height of subantral bone at the intended implant site is determined. With this information, it will be known how deeply the #1 osteotome tip can advance without contacting the actual sinus floor. Generally, this first osteotome tip should be advanced with the aid of the surgical mallet to a depth about 1 mm short of touching the sinus floor. A distinct change in sound and feel would indicate that the osteotome has reached the denser sinus floor. A periapical radiograph may be taken at any point in this step to verify the depth of penetration of the osteotome tip in relation to the sinus floor.
Endopore
Step 2 Step #1 should be repeated with the #2 and #3 osteotome tips, i.e., with site development still stopping short of the sinus floor. A plug of autogenous bone will have been collected and compacted by the osteotome tips at the apex of this partially developed osteotomy. Once this partial depth (i.e., to within ~1 mm of the sinus floor) has been achieved with the #3 osteotome tip, it is generally recommended that a particulate graft material be used to supplement the autogenous bone plug that has been developed at the osteotomy apex. This graft material should be gently packed into the site using sterile technique, and at this point the #3 osteotome tip and surgical mallet used to upfracture the sinus floor at the site. Care should be taken not to advance more than 1 mm in site depth at this time in order to minimize the risk of damaging the Schneiderian membrane.
16 Step 3 Once the sinus floor has been upfractured, it is wise to check visually to ensure that there remains a definitive roof of graft material at the osteotomy apex. If an antral communication has been accidentally created by advancing too far apically, the procedure should likely be aborted and appropriate action taken. If as expected a definitive roof to the osteotomy can be seen, site development should continue by first adding more of the particulate graft material, compacted it gently and then advancing to a further 1 mm of osteotomy depth with the #3 osteotome tip and surgical mallet. This cycle of adding graft material and advancing a further 1 mm should be continued until the full depth of the implant site (generally 7 mm has been reached). It is NOT necessary to use an Endopore implant longer than 7 mm for this application. Using a longer implant only increases the risk of Schneiderian membrane damage.
Endopore BICORTICAL
Step 4 Once the full depth (generally 7 mm) of the site has been reached in Step #3, the appropriate trial-fit gage (see the chart on page 13) is used as the final osteotome tip and fully seated with the surgical mallet. Once seated, the trial-fit gage should be snug fitting and immobile if the implant is later to be properly stabilized.
Step 5 The implant is carefully removed from the sterile packaging and delivered directly to the site using the attached white delivery tool only. The implant is pressed into the bleeding site with manual pressure and the delivery tool disconnected from the implant using a gentle rocking motion. Care should be taken to avoid inadvertent contact of the porous surface of the implant with anything prior to its full seating into the prepared site. Such contamination could lead to foreign body reaction and failure of the implant to integrate.
17
Step 6 The implant is driven to its final position with several firm taps with the punch tip and mallet, resulting in a tight fit of the implant into the bone. In all cases, the entire porous-surfaced region of the implant must be submerged in bone (around the entire periphery of the implant).
Step 7 The tapping action of seating the implant may loosen the cover screw; therefore it is important to manually tighten the cover screw using the 0.05 hex driver and finger pressure. At this point the implant must remain immobile.
Step 8 The flap margins are repositioned and sutured in a tension free manner.
Endopore
Implant Loading
The minimum healing period, prior to the commencement of prosthodontic work for the Endopore implant is 10 to 14 weeks in the anterior mandible and 16 to 20 weeks in the maxilla and posterior mandible. However, the time period is dependent on bone quality. The longest healing intervals will be where the indirect sinus elevation has been done at the time of implant placement in sites where the initial bone height was less than 5 mm below the sinus floor.
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Endopore Key Protocol Features for First and Second Stage Surgery
Endopore BICORTICAL
Avoid
Overheating of bone ur chatter, deformed osteotomy site B Undesired implant angulation Creating an oversized osteotomy site which would result in poor initial implant stability Placing the implant in a poorly vascularised osteotomy site which might result in failure to integrate Surgical gauze around the surgical site Under-seating the implant Contamination of the surface and ultimate failure to integrate Rotation of implant Use of torque wrench might mobilize the otherwise stable implant Rotating implant as it will not integrate Avoid implant overload
19
Avoid
Full thickness flap Use of torque wrench might mobilise the otherwise stable implant Use of torque wrench might mobilise the otherwise stable implant Record impression before gingiva has healed
Please note this page is only a reminder of key-points. We highly recommend to read the entire surgical manual before implant placement.
ENDOPORE Implant
Internal Connection Internal Hex
INTERNAL
PERFECT SURFACE
INTERNAL HEX
PeRFeCt
External Hex
OsteOtOMe PROCEDURES
EXTERNAL HEX
PerFeCT SURFACE
Sybron Implant Solutions The dental implant platform of Sybron Dental Specialties (SDS) brings together three (INNOVA ORALTRONICS ATTACHMENTS) organizations that have been leaders in implant manufacturing, design and development since the inception of implant dentistry. With our most respected, innovative implant systems PITT-EASY, and ENDOPORE we are giving you access to a world of implant solutions.
Manufacturer: Sybron Implant Solutions 1717 West Collins Avenue Orange, California 92867 United States www.sybronimplants.com Distributed by: Sybron Implant Solutions GmbH Julius-Bamberger-Strae 8a 28279 Bremen Germany Phone +49 421 43939-0 Fax +49 421 443936 www.sybronimplants.de info@sybronimplants.de
07-0187: 06/07