i-SYSTEM IMPLANTS

i-system implants are indicated in the upper and lower jaw for replacing single teeth or anchoring bridges. Furthermore, removable dentures can be anchored using i-system implants in cases of partial tooth loss or in edentulous jaws. In standard situations, i-system implants are planned and placed using a classic two-stage procedure with a submerged healing phase of at least four months. In the case of additional augmentation procedures, these healing periods should be extended according to the technique used and the practitioner's experience; a submerged healing phase of at least six months is recommended. Transgingival healing should be avoided or carefully considered.

IMPLANTATION

Implant insertion must be performed under sterile conditions; perioperative antibiotic prophylaxis is recommended. According to the BDIZ/EDI consensus conference of February 6, 2016, users of short and ultrashort implants must have received appropriate training in the application of this technique.

During the surgical procedure, care must be taken to ensure that the implant is inserted according to the bone volume, shape, and other important anatomical features.

Only the i-system operating tray should be used for preparing the osteotomy site. The use of operating trays from other, similarly designed implant systems should also be avoided, as i-system implants have a unique external geometry.

The drill speed should be limited to a maximum of 50 revolutions per minute to prevent heat necrosis of the bone. The osteotomy should be performed dry, which provides excellent visibility of the surgical field and ensures high patient comfort. Using this low-speed protocol allows for the harvesting of a large amount of augmentable bone from the osteotomy. The 2.0 mm pilot drill can be used at a higher speed, but must then be cooled with sterile saline solution.

The i-system operating tray includes two different drill geometries:

The "L-Reamer" has two sharp cutting edges positioned laterally along the drill's longitudinal axis. The tip of the L-Reamer is blunt, therefore no depth of osteotomy can be achieved. This better protects sensitive anatomical structures located below the osteotomy. The osteotomy is prepared symmetrically, meaning that bone removal from the walls of the osteotomy is uniform on all sides.

The i-Reamer has only one sharp cutting edge, which is also located laterally along the longitudinal axis of the drill. Therefore, this drill can be used for asymmetrical osteotomy preparation (especially in conjunction with the straight handpiece for manual preparation). This allows either physical correction of the osteotomy center point or, simultaneously, targeted expansion of soft bone and bone removal only from the hard portion of the osteotomy wall. Bone compaction can be achieved by rotating the i-Reamer counterclockwise. The i-Reamer has a cutting tip, allowing the osteotomy depth to be increased if necessary.

The outer shape of all drill bits corresponds to the implant geometry; therefore, the last drill bit must always be selected according to the diameter of the intended implant. Finally, all remaining bone chips must be removed from the osteotomy.

When using navigated surgical templates, the use of single-patient drills is strongly recommended for all preparation diameters that pass through the guide sleeves of the navigation template. This prevents excessive wear of the cutting edges on the high-quality drills of the i-system surgical tray and ensures that the drills retain their exceptional sharpness for a long time. The use of single-patient drills can also be helpful for the initial drill diameters in cases of extremely hard bone.

i-system implants are housed in a high-quality tube made of medical-grade PEEK. To remove the implant, the PEEK sleeve must be gently squeezed at the designated flattened areas with light finger pressure to allow the cap to be easily removed. This slight squeezing of the PEEK sleeve also securely prevents the implant from falling out. The implant can be removed from the PEEK sleeve and inserted into the osteotomy using either the color-coded healing plug or the insertion tool located in the surgical tray. Avoid rubbing or scratching the implant against the inside of the PEEK sleeve when inserting the tool. A slight rotating and pivoting motion of the implant can facilitate correct positioning within the osteotomy.

The implant should slide into the osteotomy without pressure; primary stability in the classical sense is not intended. The seating tip located in the operating tray, attached to one of the two handpieces, can be used to assist this process, with careful application of the hammer. We expressly point out that "hammering" the implant into the osteotomy is contraindicated, as this can cause plastic deformation of the implant shaft and base. If simple insertion is not possible, the implant must be removed and the last drill diameter used again to enlarge the osteotomy.

It is sufficient if the implant is securely aligned in the prosthetically correct axis. The insertion depth should be at least 1 mm below the deepest point of the bone; insertion depths exceeding 4 mm should be avoided. An insertion depth of 2 mm below the deepest point of the bone level is considered ideal. As a rule of thumb, it is better to use a shorter implant than to fall below this minimum insertion depth. The osseointegration guarantee provided by Novodent SA for i-system implants requires documentation of the correct insertion depth with a postoperative radiograph.

The correct prosthetic axis should be checked using the guide pin located in the tray. In case of an axial deviation, an axis correction of up to 15° can be achieved by rotating the implant, depending on bone quality. It should be noted that the shorter the implant, the easier such axis corrections are. For most indications, lengths of up to 6 mm are considered sufficient for i-system implants.

After correct positioning of the implant, the shaft is closed with the color-coded healing abutment. This is shortened to the crestal level using the i-system scissors located in the surgical tray. For insertion depths not exceeding 1 mm, the supplied black PEEK plug can also be used. For internal sinus floor elevations, a special sinus lift abutment is available, which secures the implant against unintentional slippage into the maxillary sinus.

To optimize crestal bone preservation, the circular gap between the healing abutment and the wall of the osteotomy is filled with the bone collected during the drilling process to cover the sloping implant shoulder.

Finally, a tension-free, saliva-tight wound closure using atraumatic, thin suture material is mandatory to achieve predictable and successful osseointegration of the implant

RELEASE

After observing the aforementioned covered and stress-free healing periods, the implant must be opened by making a suitable incision and removing the healing plug. The incision should be made in such a way as to ensure a sufficient band of adherent gingiva both vestibularly and orally to the implant emergence site.

According to the planned prosthetic procedure (classic abutment system / i-LiNQ® abutment system), the appropriate components must be selected and inserted. After allowing sufficient time for soft tissue healing, the prosthetic restoration can begin. Depending on the specific situation, the appropriate impression post, the corresponding model analog, and a suitable abutment must be selected and applied according to the recommended protocol.

Only impression posts and abutments from the i-system product portfolio, specifically designed for this purpose, may be used in i-system implants. Products not belonging to the i-system product portfolio must not be used in i-system implants.

DOCUMENTATION

The patient's medical record must document the type of implant and its unique identification number. The components used for the implant are also subject to documentation requirements.

GUARANTEE

Novodent SA provides a lifetime warranty on i-system implant materials for all implants. This warranty is valid if proper handling of the implant and its prosthetic components in accordance with these application guidelines can be demonstrated through appropriate written and radiographic documentation.

GENERAL INFORMATION

All implants are intended for single use. The products must be stored in a dry place until use. If the products have an expiration date, they must be used before this date. The packaging should only be opened shortly before use. Contact with foreign objects and materials must be avoided. The implant surface must not be touched or contaminated. Any damage to the outer implant packaging must be reported immediately upon receipt of the delivery. Damage to the inner sterile packaging is extremely unlikely, but can naturally only be detected at the time of the procedure. As we diligently investigate every incident, we ask that you document any complaint on the provided complaint form and return the damaged product to us immediately.

Please be sure to read the instructions for use included in each package. For further technical or clinical questions, please feel free to contact us and our clinical director.