Instruction for Use

Dental Implants Indications

This Surgical Manual serves as a reference for use of the Dentalis Bio Solution Implants. It is intended solely to provide instructions on the use of Dentalis products. It is not planned to describe the methods or procedures for diagnosis, treatment planning, or placement of implants, nor does it replace clinical training or a clinician’s best judgment regarding the requirements of each patient. Dentalis strongly recommends appropriate training as a prerequisite for the placement of implants and associated treatment. The procedures illustrated and described within this manual reflect idealized patient presentations with good adequate bone and soft tissue to accommodate implant placement. No attempt has been made to cover the large variety of actual patient conditions that may adversely affect surgical and prosthetic outcomes. Clinician judgment as related to any specific case should always supersede any recommendations made in this or any Dentalis literature. Dentalis Implants ® offers a wide variety of titanium implant systems with variety Diameters and lengths for providing a large range of clinical solutions for the broad spectrum of challenges faced by implant-dentistry. Each and every particular implant design is based on several years of research and development, offering a solution for all clinical scenarios, from basic ones to the most complex. The implants have been designed to be used in either the mandible or the maxilla from single tooth to replacement to full arch reconstruction or to support removable or fixed prostheses. The implant placement procedure should be performed by a properly trained surgeon. Dentalis Implants® are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions. Patients should have no contraindications for the procedure, should be fully informed of the benefits and risks and should have executed an appropriate consent form. Dentalis ® Implants strongly recommend that clinicians, new as well as experienced implant surgeon go through special training before activity a new treatment method.

Contraindications

Patients with alcohol addiction or psychiatric disorders, blood dyscrasias, uncontrolled diabetes, hyperthyroidism, oral infections, malignancies or patients who have had myocardial infarction within the last 12 months. Patients with systemic diseases that compromise the immune system, such as AIDS, patients with a history of poor or non-compliance to oral hygiene procedures, patients on medications that would compromise healing of an implant site, disease of connective tissue/collagen diseases or patients who cannot maintain oral hygiene procedures if implants are placed. Use of Tobacco increases the occurrence of complications and failures. Insufficient bone volume, and soft tissue coverage and/or inadequate bone quality. Residual roots and inflammatory conditions of the jaws e.g peri apical lesions, active periodontal disease and acute dentalveolar abcesses.</>

Material

All Dentalis implants ® and abutments are manufactured from Titanium Grade 23- 6A-4V ELI Alloy, ASTM F136 or from Commercially Pure Titanium, ASTM F-67.

How Supplied

Dentalis implants ® are provided sterile (by gamma radiation) and are intended for single use only. The Packaged implants supplied with 2 vials the first vial contain carrier for the cover screw, and the other internal vial is made of glass which provides an additional environmental seal include: The implant with the Hex driver Carrier. The two vials are packing in carton package that can be open only one time and cannot be close. Inspect the package and labeling for integrity. If the device is opened, damaged or contaminated in any way, it must not be used. Inside the packaging of all Dentalis products, there can be found 4 adhesive labels stating. The first and second labels are attached to the packaging of the product and the vial contained inside the packaging, while the other 2 labels are found inside the packaging for record keeping purposes which can be applied directly to the patients file. The label on the package provides the lot number, product description, catalog reference number and expiration date. To ensure sterility, dental implants must be used before the end of the expiration date indicated on the outer package label. Never reuse, re-clean or re-sterilize a dental implant. These activities can adversely affect implant materials and alter the surface characteristics, which may result in poor function and implant failure. Dentalis® abutments are supplied non-sterile and intended for single use only. Abutments should be sterilized prior to use. Do not re use Healing abutment

Precautions

It is important to obtain a thorough medical history from the patient and if necessary from the general practitioner prior to implant surgery in order to determine if conditions exist that will:

Anatomical conditions that preclude implant placement due to lack of
bone volume, vicinity to anatomical structures
Impaireed healing capacity and/or osseointegration, or
Inability to maintain proper oral hygiene of the implants, abutments and superstructures.

Handling

The external surface of titanium dental implants should only come in contact with titanium surfaced instruments. All implants are provided with Hex driver that grab the implant from his internal hex. This method will enable proper handling, transport and implantation procedures. By looking on the hex driver you will now the position of the hex implant (they are parallel) for better esthetic result.

Treatment Planning

Proper patient selection is a critical factor for success. A comprehensive patient interview and medical/dental history must be taken. A complete oral examination should then be conducted. Head and neck examination is followed by a thorough oral examination. The use of magnification is strongly encouraged as an adjunct to all procedures. Oral inspection includes palpation and the proper radiographic protocol(s). This may include peri-apicals, panorex and tomograms-CT. Palpation of the ridges is also required and the use of intra-oral probes for tissue thickness is recommended. The diagnostic procedures will give the dentist an appreciation for the tissue quality and thickness, ridge morphology for the type of implant to use, size of the implants that might be required diameter and length. Measurements for implant size can be estimated utilizing radiographs, templates, calipers and millimeter rulers. The treatment plan should determine the design-type of implant, number and position /angle of the implants. Placement of small diameter implants or the use of angled abutments is not recommended in the posterior region of the mouth. Treatment planning should also take into consideration prosthetic biomechanics, occlusion and occlusal load. Fracture due to excessive load or metal fatigue can occur on the implant body or its prosthetic components if this aspect of planning is inadequate. For ideal results in implant dentistry, the treatment team should be in agreement and in communication throughout all stages of therapy. The patient, the restorative and surgical doctors, as well as the dental laboratory should understand and agree upon the treatment plan.

Surgical Asepsis

The operating field must be isolated with sterile coverings as much as possible. As with all surgical procedures, the operatory field should be maintained with sterile coverings (light handles, chair controls, bracket tray, and all instruments and components). Barrier technology, sterile solutions and sprays, sterile coverings, and proper autoclaving techniques must be employed as indicated.

Soft Tissue Site Preparation

Once prepped (site isolation and local anesthesia achieved), the surgical procedure begins with identification of the implant site(s) via the creation of bleeding point(s). A mesio-distal incision is then made on the alveolar crest, extending approximately 3-5 mm beyond the implant site(s). It is imperative that a clear visual field be maintained at all times. The incision should penetrate to the full depth of the gingiva and the periosteum. A periosteal elevator is used to lift the periosteum and expose the alveolar bone. Any irregularities or deformities of the alveolar ridge should be eliminated or ameliorated at this time. The distance between implants and/or the natural dentition should be maintained within a range of 4-6 mm.

Penetration of the Alveolar ridge

Of critical importance is the fact that all bone-cutting procedures are CONDUCTED AT SLOW SPEEDS (60-800 RPM). Profuse, internal and/or external irrigation is also mandatory.

Before Drilling

Dentalis Implants is strongly recommend Peri-operative oral rinses with a 0.12% chlorhexidine gluconate mouthrinse (Hexidine) solution has the best anti-microbial efficacy against all the tested microorganisms. A preoperative 30-second rinse is recommended, followed by four daily rinses for two weeks following surgery.

Drilling Technique

The slow-speed, highly irrigated drilling procedure is conducted while angling the drill such that the direction of the drill bisects the ridge. The drill should also be held vertically, avoiding a mesial or distal cant. Depth gauge / alignment components can be periodically inserted into the osteotomy site to monitor the angle of penetration. Successively larger drills are used until the desired diameter is achieved. Drilling is performed with a precise, up and down pumping action. The drill angle is maintained in order to preserve the concentricity of the hole, while the pumping action allows for incremental depth penetration and periodic cleansing of the flutes. Proper spacing is essential for esthetic restorations and hygiene considerations Maintain 1.5mm from contact at crest to the edge of the implant Maintain 3.0mm edge-to-edge spacing between adjacent implants Watch for tooth roots tipped or angled beyond the contact region of the crown. A Pilot Hole should be drilled where the bone is of high density. The Pilot drill is used for this procedure. Always consider that a margin of safety of at least 1mm should be factored into treatment plans nearby to any vital anatomic structure.

Drilling Sequence for Internal Connection Implants

Lancer Pilot Drill 1.5mm Drill 2.0mm Drill 2.5mm Drill Depending on implant diameter- 2.8mm, 3.2mm, 3.5mm, 4.1mm, 5mm, 5.5mm, 6mm, 6.5mm, 7mm Drills The last drill dep't should be only to 1/3 of the implant length through the cortical bone. 6. Final Counter Sink Drills is recommended drill to only 3 mm for the cortex Bone. For Tapered Body Implants In more porous bone, in the maxilla, it is possible to use the final bone or 1/3 of the implant length in order to increase primary stability. Please note: All Dentalis Drill are machined and laser marked at the length of 6.5, 8, 10, 11.5, 13, 16mm three are some long drill that has also marked of 18, 20 mm Dentalis implant® is offering wide range of drills with External, Internal Irrigation and conical drills. The conical drill require specific technique to prevent irrigation holes becoming plugged without stooping hand piece motor, which allows the irrigation to flush away debris. Each implant length has unique drill. During the drill use an in-and-out motion and drill in the bone for 1-2 seconds. Drilling with conical drill should be at high speed of maximum 600 RPM.

Sterilization of Drills

It is extremely important to handle all drills and burs carefully. Even slight damage to their tips, as occurs if drills are “tossed” into a dish of water, can harm them. Damage to the tips impedes their cutting performance considerably! The following aspects must be observed if the drills are to be maintained properly: Place the drill “gently” in the storage dish (e.g. filled with physiological saline solution) and never drop it directly onto its tip. Never allow drills to touch one another while being cleaned in an ultrasonic unit. Dentalis Implants ®is strongly recommended the use Ultrasonic machine for the cleaning of the drills. It is important to avoid contact between the drills in the ultrasonic unit; the Ultrasonic Cleaning Cassette can be used. Never allow remains (blood, tissue remains, secretion) to dry on, always immerse the instruments in disinfectant immediately after the surgical operation. Do not use cleaning solution or disinfectant containing chloride or acid (caution with the running water too much chlorinated) Incrustations must be cleaned off thoroughly with nylon brushes only! Clean conical drills, cannulations (trephinedrills) especially well! Rinse, disinfect and clean off thoroughly with water! Sterilization by wet heat autoclaving 134°C (273° F) – 20 minutes. Make sure that the elements, inside the autoclave, are not rusted. Never store instruments while they are still moist or wet. Do not clean, Never disinfect, in the same ultrasonic box, the implant drills with other tools or instruments which material is different. For the drills with removable stops: these steps must be carried out individually on the dismantled component. The implant drills cannot be used indefinitely. Stock the drills in clean and dry areas. Only use cleaning agent/disinfectant intended for the material in question and always adhere strictly to the manufacturer’s directions for use!

Completion of Site Preparation

The implant site is periodically flushed and checked for proper depth. The drills have depth markings and a paralleling pin/depth gauge indicator is also available. The paralleling pins are utilized when multiple implant sites are prepared. As each site is completed, a paralleling pin can be inserted into the osteotomy site and used as a guide for the preparation of the next site.

Implant Installation using the Hex Driver

The Hex Drive- carrier/placement driver is used to pick up the implant directly from the vial, carry it to the osteotomy site and thread the implant into place. This driver fits either contra angle or ratchet drives and can safely exert the necessary driving force without risk of deformation of the prosthetic interface connection. The final seating of the implant(s) is achieved by the incremental turns of the Ratchet Wrench. Should bone density demand, the osteotomy site should be further prepared via the utilization of the Bone Tap. All Dentalis implants ®are self taping, A Countersink Drill is also available for those clinicians choosing the option of exercising a countersink technique.

Radiographic Verification

At this point, take the appropriate radiograph(s) to confirm proper depth, seating, orientation and placement of the implant(s).

Indication of use healing abutment

<span style="font-family: Helvetica;">To be use as a transmucosal extraction extension secures to the implant during healing of intra-oral soft tissue following insertion of the implant to the bone or after second stage surgery.
The Healing abutment is specially designed to avoid bone grow on platform and by that to prepare for the specially designed bridge impression coping. Do not re-use healing abutment.</span>

Placement of the Healing abutment

After radiographic verification, a healing screw is then placed, all Dentalis® keys are design that the tip is con to grab the healing cap for easy carry the cover screw onto the implant and thread it into place. Use the Hand-tighten with the 1.25mm- 050” Hex Driver. It is very important that the implant platform is free from tissue remnants before seating the abutment to avoid remaining gap. Dentalis implant is offering special tool for measuring the high level of the tissue for better esthetic result and wide range type of Healing abutment

Site Closure

Irrigate the site for the final time, approximate the flaps and secure with interrupted mattress sutures or suture method of choice. It is important that maximum tissue adaptation be obtained.

Important Points to Remember

The Conic Implants are designed to fit the drilled depth. Only Titanium instruments should come in contact with the implant. If a removable prosthesis is used near the implant site, it should be generously relieved and a soft tissue conditioner relines material placed.

Postoperative Care

Cold packs are recommended for the first 24 hours. The patient is advised to maintain a soft diet and avoid hot liquids and to favor the opposite side of the mouth. Sutures may be removed after 7 days. Analgesics/Antibiotics may be prescribed at the discretion of the practitioner. Peri-operative oral rinses with a 0.12% Chlorhexidine Digluconate solution have been shown to significantly lower the incidence Of post-implantation infectious complications.2 A preoperative one minute rinse is recommended, followed by four daily Rinses for two weeks following surgery. For more info: "Comparative in vitro evaluation of efficacy of mouthrinses against Streptococcus mutans, Lactobacilli and Candida albicans." Pubmed "Differences in antimicrobial activity of four commercial 0.12% chlorhexidine mouthrinse formulations: an in vitro contact test and salivary bacterial counts study." Pubmed

Indications for Dentalis Abutments

Dentalis ® abutments are intended for use with Dentalis® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla. Dentalis® is offering wide range of Anatomic abutment from Titanium grade 5 and ceramic. DENTALIS is not responsible for incidental or consequential damages or liability relating to use of our products alone or in combination with other products, other than replacement or repair under our warranties.

Sterilization of Abutments

Abutments may be sterilized using full cycle pre-vacuum steam sterilization at a temperature of 135°C - 274°F for an exposure time of 4 minutes and 6 minute drying time. Note: use of non-sterile abutment can lead to infection of tissues or infection disease.

Warning-Magnetic resonance environment

Note: The Dentalis Implant System® has not been evaluated for safety and compatibility in the magnetic resonance -MR environment. The Dentalis Dental Implant System® has not been tested for heating or migration in the MR environment.

Storage

The implants should be kept in their original packaging, in a dry area at room temperature from 5 °C to 22 °C. The implant should not be used after the expiration date on the package

Disclaimer of Liability

Dentalis implants® may only be used in conjunction with the associated original components and instruments according to Dentalis® IFU. Use of any non- Dentalis® products in conjunction with Dentalis® implants will avoid any warranty Or any other obligation, expressed or implied,of Dentalis implants®. Dentalis Implants® strongly recommends appropriate training as a prerequisite for the placement of implants and associated treatment. Treatment planning and use of the products are solely your responsibility. The clinician is obliged to study the latest development in regards to Dentalis bio Solution Implants® product. In case of doubt, the clinician has to contact Dentalis bio Solution®. Since the processing and the surgical application of this product is under the control of the clinician they are his/her responsibility .We assume no liability whatsoever for damage arising thereof. Caution: Federal law restricts this device to sale by or on the order of a licensed dentist or physician. Inappropriate patient selection, diagnosis, treatment planning or technique can result in implant failure and/or loss of supportive bone. The use of small diameter implants and angled abutments in the posterior region of the mouth is not recommended due to possible failure of the implant.