General patient information:

The patient should be informed before any treatment, guided by the results of the pre-operative examination.
Explanation of the intended treatment will include expected risks and outcomes.
Patients should indicate their acceptance of treatment by signing an appropriate consent form.
Contraindication's of patient's medical status that precludes surgical treatment include, mental psychosis,alcohol, and all listed information noted at the instruction for use.
PRIMA titanium implant should not be placed in patients where the remaining jaw bone is too diminished to provide adequate implant stability.

Warnings:

Excessive bone loss or breakage of PRIMA titanium implant may occur when an implant is loaded beyond its functional capability.
Physiological and anatomic conditions may negatively affect the performance of dental implants. Consideration should be taken when placing implants in patients with the following conditions:

• Poor quality bone
• Poor oral hygiene

Medical conditions such as blood disorders or uncontrolled hormonal conditions.
Pre-operative examination includes a general evaluation of the patient's health, and a clinical and a radiographic examination.
Special attention should be given to soft and hard tissues, dental history, restorative status, and occlusion. In complex cased accurate details can be fabricated by CT data.
Radiographic examination provides evaluation on anatomy, pathology, quantity and quality of the bone.
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.
Local contraindications

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.

Implant selection

DMI Dental Implants System is available in variety of diameters, lengths and special design. The implant site must be prepared in a way that will enable simplicity of placement, stability, will not damage vulnerable areas of the local anatomy maxillary sinus, nasal floor and inferior dental canal; and will not cause damage to the bone by overheating or trauma.

Pre Operative Handling

Planning before surgery as described above along with good understanding of the clinicians with DMI implants systems, will ensure efficient and accurate installation.
Premedication is given based on individual indications. Non allergic patient may be given 3g sachet of amoxicillin one hour before implant placement and 500 mg X3 four times daily post treatment of one week prophylactically. Preparation of the room sterilization and surgical instruments. Draping the patient with sterile operating sheets covering the body and head. Local anesthesia is given is desired areas. Additionally is being given during surgery when needed. Washing the mouth with 0.2% chlorhexidine solution for 2 minute.

Preparation of the implant site

Perform incisions to expose the surgical field.Elevate the muco periosteal flaps. Reshape alveolar ridge if necessary; the incision and flap elevation are extended to enable easy access to/and control over the implant sites and to permit satisfactory registration of the jaw morphology.
Mark the bone with a marking drill 1.9 mmd or the 2 mm drill for position the implant site. It is recommended to keep 3.5 mm distance from each implant to another, which gives a minimum center to center distance of 7 mm. For precise spacing and parallel placement use parallel guide, more options are available.
For angulations, depth and parallel to be checked use parallel/depth guide, more options are available. For future restoration for placement abutments use Surgical Set Abutment “Navigate”( Surgical Straight “Navigate” Abutment, Surgical Angular 15° “Navigate” Abutment or Surgical Angular 25°”Navigate” Abutment).
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.

Drilling

Implant 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

The surgical drills come in sequential diameters and in two lengths. The drills are made of surgical titanium and are to be used with internal irrigation. A Teflon ring in the irrigation canal facilitates friction free insertion of the irrigation tab.
All drills are color and groove coded for easy identification during surgery.
Drills are groove marked for lengths.
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.

Preparing the PRIMA titanium implant

The PRIMA titanium implant of DMI are provided in a double packaging in order to reserve sterility. The outer packaging is made from recycled materials, carton paper, which indicates the identification data of the PRIMA titanium implant, measurements, type, expiry date, sterile, brand name, manufacture, representative, CE mark. Within the Outer packaging, there is a PRIMA titanium implant in a double sterile package, 2 labels, instructions for use.
The assistant opens the external packing and puts out from it the internal packing. From the internal packing the carrier of the PRIMA titanium implant connected with the PRIMA titanium implant is going out.
The doctor should extract the PRIMA titanium implant by the carrier not touching the walls of the inner test tube and transfer it to the formed hole in the osseous.

Inserting the PRIMA titanium implant

Initial insert of the PRIMA titanium implant into the prepared site manually:
While installing of the screwed PRIMA titanium implants it is possible to screw the implant manually or with the help of the physiodispencer, which can be tuned on the definite speed. The manual screwing is started by the holding with the fingers the PRIMA titanium implant by the carrier till the strong resistance is felt and then by means of the key “Ratchet” or “Bush”.
The 2.42 mm insertion tools can then be inserted directly into the PRIMA titanium implant to continue insertion.
As soon as you encounter resistance start using the wrench or the surgical screwdriver.
If proximity to teeth does not allow insertion of the PRIMA titanium implant with the pre mounted carrier, you can pull it straight out (it is held with friction) at any time during insertion and replace it with a 2.42 mm insertion tool. These tools come in three options for use, with accordance to the PRIMA titanium implant type, with the wrench or screwdriver (hexagonal 6.35 mm) or with a square 4 mm wrench.
Alternatively you can use the 2.42 mm motor mount for contra angle tool for motorized insertion. Install at low speed (20 rpm) with ample irrigation. Set the maximum torque to 45 Ncm.
Caution: Excessive force while inserting the PRIMA titanium 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 PRIMA titanium implant counterclockwise 2-3 rounds then continue to insert the PRIMA titanium implant. Or retrieve the PRIMA titanium implant and drill a wider hole.

Installation of cover screw

In case of a two-stage surgery, remove the cover screw(700638) 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 PRIMA titanium implant and tighten it lightly.

Immediate implantation - The 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 PRIMA titanium 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 PRIMA titanium implant allows insertion into a small drill hole and gradual condensation in all dimensions throughout the entire length of the PRIMA titanium implant.

Immediate Implantation Aesthetic Zone - Achieving aesthetic results in the anterior maxilla is very difficult and considered 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 1.5 mm of bone thickness buccal to the PRIMA titanium implant.