Surgical Protocol - Tidal Spiral · some additional benefits: The new implant allows closer placement of ... can be at the implant's apex as in a freshly extracted tooth socked or

The is a conical internal hex implant with a unique combination of design features that enable easy insertion and very high initial stability.The unique shape of the implant body and its variable thread design equip it with some exceptional abilities. It is self drilling, self tapping and self condensing, yielding outstanding advantages in all bone types and compromised situations.

The implant offers better control during insertion and high initial stabilization in all bone types with as little as 2-3mm of bone. Small diameter drilling results in minimal bone loss and reduced trauma. Location and orientation of implant can be altered even after insertion without trauma to the surrounding tissues.Its advantages are particularly obvious and unmatched in situations where there is minimal amount of bone and low bone density, compromised

Surgical Protocol FOR TIDAL SPIRAL IMPLANT SYSTEMS TSI

1

achieving high stabilization in freshly extracted sites and thin sinus floors without prior bone augmentation.The spiral implant is therefore the champion of immediate placement and immediate loading.

The TSI implant shares all the unique features of the spiral and in addition incorporates a different head design. Its narrow head allows for an increased volume of crestal bone round the implant neck. That accounts for some additional benefits: The new implant allows closer placement of adjacent implants without compromising health of tissue and aesthetic outcome. There is no resorbtion of surrounding bone, even after loading. This desirable consequence of the head design is demonstrated in all procedures: delayed implantations, immediate implantations, one stage and two stage procedures, delayed and immediate loading. The new head design promotes soft tissue health without loosing its height. There is sufficient support for the tissues so that the original height of papillae can be maintained even between adjacent implants.

Indications:

The spiral implant is indicated for all situations, bone types and surgical protocols.� Single missing tooth, par al edentulism, total edentulism.� Upper and lower jaws, anterior and posterior regions.� One stage and two stage surgical procedures.� Immediate implanta on and immediate loading.

2

New Generation Dental Implant System

Internal hex connection for superior aesthetics and to facilitate positioning and securing of the implant0.3 mm machined collar to prevent gingival retractionand promote ideal oral hygiene maintenance

Parallel micro grooves on the neck of the Implant to facilitate osseo- integration and to prevent bone resorbtionParallel micro-threads at the neck of the Implant to reduce stress in the crestal boneSpecial tapered spiral design for : high primary stability high secondary stability minimum lateral stress self tapping and correct seating

Asymmetric spiral grooves for stress distribution and bone condensationpromoting the increase in Secondary Stability 2 vertical cutting slots at the apical third designed to improve self tapping action and the development of increased ‘ anchorage’ of the Implant

Flat apex designed for sinus lift techniques

3

Surgical Protocol:

Examination and treatment planning:

Carry out examination and treatment planning in the usual manner. Bear in mind that in the majority of cases the implant's special abilities reduce the need for an additional surgical procedure of bone augmentation prior to the implant placement session even in compromised situations. The implant can be stabilized in very little bone and bone augmentation can be carried out in the same session.

Bone Quality:Traditionally, dense compact bone provides good initial stabilization for the installed implant while cancellous bone provides much reduced retention and therefore more of it is necessary for a high enough initial stabilization.

Bone Quantity:Amount of bone available for implant retention differs from site to site. Regular implants require sufficient quantity (a few millimeters) of good quality bone for minimal retention to achieve immediate stabilization in order to yield a successful result. In all situations where the initial stabilization is questionable it is necessary to augment the bone volume prior to implant insertion. This calls for an additional surgical procedure and a much prolonged process. The unique design features of the spiral implant

4

allow it to be anchored and stabilized in as little as 2mm of non cortical bone anywhere along the implant's length. The thin layer of available bone can be at the implant's apex as in a freshly extracted tooth socked or at the implant neck as in a sinus lift situation.

The implant is active at its apical part, enabling an angle change during insertion. This ability facilitates engaging in parallel to bone walls thus allowing anchorage in freshly extracted socked walls.

Diameter of drilled site:

The special features of the implant allow insertion into a small diameter site.

Depth of drilled site:

The self drilling capability of the implant allows it to be inserted into sites that have been prepared to a reduced depth.This ability becomes very useful in situations of close proximity to vital anatomical structures such as the mandibular nerve canal or the maxillary sinus and nose cavity. It could also be utilized in softer bone when maximum condensation is desirable.

5

.Preparation of the implant site:

1. Perform incisions to expose the surgical field.2. Elevate the mucoperiosteal flaps.3. Reshape alveolar ridge if necessary.4. Mark the bone with a guide drill.

Guide drills are not included in the kit. You can use a guide drill of your choice like a round bur or a sharp pointed guide drill. Mark drilling speed should not exceed 1,500 rpm and should be performed under ample irrigation.

DrillingImplant site is prepared in a sequential procedure using drills of increasing diameter with depth indication lines that give a reading of the desired drilling depth.Drills should be replaced when their cutting efficiency is reduced. All preparation of bone tissue must be carried out under ample irrigation with saline solution and using an intermittent drilling technique.

Drill selection

All drills are color and groove coded for easy identification during surgery.Drills are groove marked for lengths as shown below.

Spiral Special Feature:Drilling a narrower hole saves time, preserves precious bone tissue and

allows the special incremental bone condensation feature of the implant to take effect resulting in enhanced initial stability.

6

Nominal length marks are measured from the beginning of the parallel walls. The length does not include the triangular shaped cutting edge. Actual osteotomy length is roughly 1mm longer. It is important to bring into consideration the additional length in situations of close proximity to anatomical structures such as the mandibular nerve canal or sinus floor.Optional surgical drills with flat heads are also available for such situations.

Drilling sequence

The drilling protocol is adapted to the implant diameter and bone quality at the site.The instructed drilling steps are suggested for dense/cortical bone. In softer bone fewer steps may be performed. In soft bone, 2mm or 2.8mm drills are often enough for all implant sizes (see protocol below).

7

Drilling Sequence Protocol for Bone Types I and II:

In very hard cortical bone it may be necessary to drill with the next size drill just for the thickness of the cortical layer.

(New "Cortical Drills" will be available).

For bone types 3, you can skip last drilling step. When the bone is verysoft, skip last two drilling steps.

Due to its special design it is possible to insert the implant into a prepared site of a much lower diameter than usual, thus allowing preservation of precious bone tissue and allowing the special incremental bone condensation feature of the implant to take effect. The resulting retention and stability are much higher without using bone condensing accessories such as osteotomes. It should be noted however that in case of high resistance to insertion (50 Ncm) as in a site with a substantial cortical bone layer additional steps may be necessary though usually not to the full length. If you feel strong resistance at any point during insertion, rotate the implant counterclockwise 2-3 rounds then continue to insert the implant.

Preparing the implant:

All implants are delivered in sterile double packaging. The transparent outer blister houses a vial that includes the pre-mounted implant and a cover screw (if applicable). The vial's end is labeled with the implant type and diameter and color coded for implant length. A sticky label displays all pertinent information regarding the implant. Two labels are supplied in the

8

package. Open the blister package and place the vial on the sterile working area. When ready to place the implant, pull the pre-mounted implant out of the vial and place it directly into the prepared site. Avoid contact between implant and other oral tissues or saliva.

Implant Mount

Implant mount supplied with all TSI implants. It is attached to the implant by friction on one end and has external (6.35mm) and internal (2.5mm) hex mounts on the other end.

This delivery system simplifies the implantation process. The hex connectors allow the use of ratchets, surgical screwdriver and extension parts. There is no need for a screw driver to disconnect the implant from its mount. It is released by simply pulling it out at any stage during the insertion process. The 2.5mm insertion tools can then be inserted directly into the implant to continue insertion.

Inserting the implant:Start inserting the implant into the prepared site manually. As soon as you encounter resistance start using the wrench or the surgical screwdriver.If proximity to teeth does not allow insertion of the implant with the pre mounted carrier, you can pull it straight out (it is held with friction) at anytime during insertion and replace it with a 2.5mm insertion tool. These tools come in three lengths for use with a square 4mm wrench.

Alternatively you can use the 2.5mm motor mount for contra angle tool for motorized insertion. Install at low speed (20rpm) with ample irrigation. Set themaximum torque to 45Ncm.

9

CautionExcessive force while inserting the implant with the wrench or screwdriver must be avoided. It could cause undue compression of the bone and result in necrosis and impaired result. If you feel strong resistance at any point during insertion, rotate the implant counterclockwise 2-3 rounds then continue to insert the implant. Or retrieve the implant and drill a wider hole.

Installation of cover screwIn case of a two-stage surgery, remove the cover screw from its plastic holder (found at the bottom of the vial) using the hexagonal screw driver or the contra angle mount hex driver. Insert the cover screw into the implant and tighten it lightly.

One-stage surgery:When stabilization is adequate and a one stage protocol is desired a transmucosal healing abutment should be placed.

Special surgical protocols

Self drilling The self drilling capability of the implant allows it to be inserted into sites that have been prepared to a reduced depth.This ability becomes very useful in situations of close proximity to vital anatomical structures such as the mandibular nerve canal or the maxillary sinus and nose cavity. It could also be utilized in softer bone when maximum condensation is desirable.

10

Drill to 6-8mm, insert implant to drilled depth and continue to insert. The implant will drill its way into its final depth.

Do not rely on self drilling and self tapping abilities of the implant in situations where bone structure and density require too high a force for insertion (higher than 50 Ncm).

Immediate implantation

The unique design features of the spiral implant allow it to be anchored and stabilized in as little as 2mm at the bottom of freshly extracted sockets particular lead angle of the deep and sharp threads and their osteotom-like condensing action enables non traumatic insertion and excellent retention that is sufficient for stabilization of the implant. Bone augmentation can be immediately followed as indicated – all in the same session.

Closed and Open Sinus Floor Elevation

The unique design of the implant allows insertion into a small drill hole and gradual condensation in all dimensions throughout the entire length of the implant. This feature results in good stabilization in as little as 2-3mm of bone even at the neck of the implant, allowing bone fill and other

Spiral Special Feature – Self DrillingDue to its unique design features the implant can be inserted into anarrow drill hole some times not even to the full length of the finalplacement.

11

augmentation procedures to be done at the time of implantation. There is no need for a separate procedure of bone augmentation and a long wait prior to the implant placement procedure.

Immediate Implantation – Aesthetic Zone

Achieving aesthetic results in the anterior maxilla is very difficult andconsidered highly unpredictable. The buccal bone plate is usually very thin and oftentimes missing altogether, whereas maintaining bone height and soft tissue architecture requires at least 1.5mm of bone thickness buccal to the implant.Regular implants tend to slide into low resistance areas at the bottom of the socket and in order to achieve the desired results bone augmentation must be performed prior to implant placement. Sometimes more than one session of bone augmentation is required for sustained results. The TSIlimplant changes all that. It allows you to anchor the implant into the palatal wall with excellent stability leaving ample space for bone augmentation on

Spiral Special FeatureThe unique design features of the spiral implant allow it to be anchored and stabilized in as little as 2mm of non cortical bone anywhere along the implant's length. The thin layer of available bone can be at the implant's apex as in a freshly extracted tooth socked or at the implant's neck as in a sinus lift situation. No prior bone augmentation is necessary thus reduced. number of surgical steps and overall treatment time is reduced.

12

the buccal aspect. The resulting thick buccal bone assures bone height after remodeling.

Thus tooth extraction, implant placement; bone augmentation and even immediate loading can all be done in one session with excellent and sustained aesthetic outcome.

Technique1. Tooth is extracted and the fresh socked is prepared in the regular manner.2. The palatal wall is penetrated with a small diameter drill perpendicular to its plane.3. Use the Surgical Driver to insert the implant at the same (almost horizontal) angle.4. When the implant tip is secured (2-3 turns) continue insertion while constantly changing direction toward the desired orientation.

The implant's cutting and condensing abilities make this maneuver possible with total control.5. Place healing abutments for regular one stage protocol with delayed loadingor prosthetic abutments for immediate loading. 6. Perform Bone fill and other augmentation procedures as required.

Spiral Special Feature - Controlled guidance of insertionDue to its unique design features the direction of the spiral implant canbe controlled and altered during insertion. This feature allows controlledinsertion without slipping into low density regions.

13