Unique Titanium Short Implant Internal Hex H2.43

Unique Titanium Short Implant Hex 2.43 Multi-Lock

Before using DMi dental Unique Titanium Short Implant, the dentist / oral maxillofacial surgeon must carefully study the indications, contraindications, recommendations, warnings and instructions, as well as all other product-specific information (product description, description surgical and reconstructive equipment, catalog, etc.) and fully included communicate with them. DMi also recommends visiting our corresponding refresher courses managed on site and remotely by authorized DMi specialists. Above mentioned documents and training details courses can be obtained from the relevant representatives in different countries and on the company website: www.dmimplant.online

Product Description:

Unique titanium short implant standard size hex 2.43 multi-lock is a titanium dental implant of self-tapping, pronounced conical shape, with variable thread, with an internal connection Hex2.43. The implants are made of medical titanium alloy Ti6Al4V ASTM-136. 

The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores measuring 1-4 microns and macropores measuring 30-40 microns. 

The external thread of the implant has a double helix shape. Standard size Implants are available in diameters from 3.75 mmd to 8.0 mmd and lengths from 5 mm to 7 mm. All implant diameters have a 2.43 mm internal hex connection and 1-72 UNF internal implant threads. 

Packaged in double sterile packaging with a one-time use implant holder and titanium cover screw. The one-time use implant holder holds the implant using a clasp. After inserting the implant into the prepared bone implant bed and obtaining initial fixation of the implant in the bone, the carrier is removed with a vertical movement. The titanium plug screw is designed to close the internal connection of the implant. 

The implant set is sterile and intended for single use. Before use, it is recommended to read the instructions for use. 

Intended use, indications for use

The short titanium implant DMi Unique is intended for reconstructive surgery to restore a missing tooth. The short titanium implant DMi Unique is installed in the jaw bone of the upper or lower jaw, in the area of missing teeth with insufficient bone volume for installing a standard size, to provide support for prosthetic devices (artificial teeth, etc.) in order to restore the patient's chewing function, aesthetics, etc. It is used in all types of jaw bones D1, D2, D3 Implantation areas: all parts of the upper and lower jaw. Indications: -standard dental implantation methods, basal implantation, direct implantation. Special tools for bone preparation and implant installation.

Advantages:

• large selection of sizes,
• minimum implantation time in the bone,
• the possibility of installing implants with pronounced vertical resorption of the jaw bone (where standard sizes are impossible)

CONTRAINDICATIONS

The conditions listed below may contribute to a lack of integration and/or subsequent rejection of the implant. This suggests the presence of diseases and certain conditions of the body, when surgical intervention poses an obvious risk to health, as well as in the presence of incurable diseases that make it impossible to achieve positive results of implantation. These include:

• Chronic diseases in the stage of decompensation.
• Systemic disorders of bone metabolism disorders.
• Uncontrolled bleeding disorders.
• Immunodeficiency, AIDS and any other seropositive infection.
• Mental illness.

Relative contraindications or risk factors

Relative contraindications are diseases that create certain difficulties in achieving the desired result, statistically reduce the effectiveness of implantation and may lead to treatment failure.

Risk factors include an unfavorable anatomical condition of the hard and soft tissues of the jaws, osteolytic, inflammatory or infectious activity in the implantation zone, deformity of the bite and dentition, bruxism and diseases of the oral mucosa requiring additional surgical interventions or non-standard approaches to treatment.

Risk factors are:

• Wrong lifestyle, intellectual and emotional status,
• Acute and chronic diseases in the stage of compensation, pathologies in which homeostasis can be stabilized or compensated ,
• Changes in the organs and systems of the body due to modern methods of treatment.
• Acute inflammatory diseases and acute viral infections, infections of the oral cavity
• High risk of bacteremia (patients with prosthetic heart valves and past bacterial endocarditis, rheumatism).
• Patients with heart and lung disease, especially those who have recently had a heart attack or stroke.
• Pregnancy and lactation.
• Treatment with drugs that impair tissue regeneration: immunosuppressant, hormonal, etc.
• Young people under the age of 21
• Osteopathic diseases: osteoporosis and osteomalacia.
• Uncontrolled systemic diseases that violate osteogenesis: diabetes mellitus, diseases of the thyroid or parathyroid gland and pituitary gland, pathology of the adrenal glands, blood diseases such as hemophilia, granulocytopenia or other blood clotting disorders; Ehler-Danlos syndrome, bone-beam necrosis, renal failure, organ transplantation, fibrous dysplasia, regional enteritis.
•  Alcoholism and drug addiction.
• Systemic connective tissue diseases: systemic lupus erythematosus, dermatomyositis, Siegen’s syndrome, a group of congenital systemic connective tissue diseases inherited in an autosomal dominant manner: Kind’s, Gerley’s, Meknes’s syndrome, Gauthier’s disease, Niemen-Pick syndrome, various types of congenital dysplasia and dysostotic.
• Allergy or hypersensitivity to the chemical components of the materials used.

Risks and complications:

Risks associated with the surgical procedure may include accidental sinus perforation, local and systemic infections, and nerve damage. 

Temporary conditions may include pain and swelling, speech problems, and gingivitis. Long-term problems may include nerve damage, localized bone loss, hyperplasia, local or systemic bacterial infections, and endocarditis.

1. Risks and complications associated with the surgical procedure may include:- temporary or permanent nerve damage; - temporary or permanent violation of the mobility of the facial muscles; - local, temporary, or permanent disturbances of sensitivity; - Infections, sinusitis; -bleeding; - local pain, pain in neighboring teeth; - edema; - problems with speech; - difficulty swallowing; - Inflammation and swelling of the gum mucosa; - loss of jawbone and gums; - loss of implant integrity, implant mobility, implant loss.

2.Risks and complications associated with implant prosthetics may include: - pain when chewing; - loosening of abutment screws, unscrewing and loss of forming abutments; - loss of fixation and loss of prosthesis design on implants; - fracture of the prosthesis design

Preoperative preparation:

Before the surgical treatment of the patients, it is necessary to conduct general and also local preoperative preparation. The aims of the preoperative preparation are the maximal reduction of the inflammatory phenomena in the periodontal tissues, soft and hard tissues oral cavity, for the prophylactics of complications and creating optimal conditions for the reconstruction of the damaged periodontal tissues during and after surgical procedure.

Conditionally the preoperative preparation before the surgical interference can be divided into: 

- Local treatment:

1.  Sanitation of the mouth cavity (the treatment of the complicated and non-complicated caries of the teeth, the removal of the teeth, anti-inflammatory therapy of the periodontal tissues) 

2. Hygiene of the mouth cavity (Removal of unwanted dental plaque and calculus, good teeth polishing). Instruct the patient on the rational hygiene of the mouth cavity.

3. Immobilization of the mobile teeth, removal of the traumatic occlusion.

4. Selective grinding of the teeth and leveling of the occlusive surface.

5. Making of the temporary prosthesis under numerous removal of the teeth.

6.  When there is an inflammation of the soft tissues, to use antibiotic therapy.

7. In case of fungal infection of the oral mucosa, the use of anti-fungal therapy.

8. In bruxism, complex treatment with the making a hard night , a mouth guard on the upper jaw to lift the bite.

General preoperative treatment depends on the patient’s chronic disease, the patient’s general condition and the type of anesthesia being planned.

In chronic diseases, the patient must take the full necessary treatment prescribed by his general physician. An exception is drugs against blood clotting. It is necessary to stop taking drugs against blood clotting 5-7 days before the surgical procedure or replace it with other drugs.

In case of fear and anxiety of the patient before the surgical procedure, sedative drugs are prescribed for 2-3 days and an additional sleeping pill is prescribed in the night before the procedure.

With an increased gag reflex, antiemetic drugs are prescribed for 2-3 days.

When planning for general anesthesia or deep sedation, all appointments in the preoperative period are prescribed by the anesthesiologist with mandatory consultation with the dentist. 

The goal of antibiotic prophylaxis in surgery is to prevent the development of superficial and deep wounded infections. In many randomized clinical studies, it has been shown that prophylactic antibiotics can significantly reduce the development of postoperative wounded infections. The time and dose of antibiotics before the surgical procedure depends on the general condition of the patient. For patients with common chronic diseases, with any transplants in any organs and artificial heart valves, etc. antibiotic prophylaxis should be started 2 days before the procedure. On the day of the procedure, a single therapeutic dose of the antibiotic should be administered once intravenously or orally just before the incision of the mucous membrane and simultaneously with the start of induction anesthesia, that is, before bacterial contamination of the tissues, to create an effective concentration of the drug in the tissues throughout the operation. Antibiotics are most effective when they are injected prior to contamination of the tissue with bacterial wounds.

- In most “clean” or “conditionally clean” operations, including operations involving the implantation of prostheses and osteotropic materials, the choice of antibiotic is cefazolin or Augmentin in combination with a drug with anti-anaerobic dependence, which should be administered immediately. before the incision and the start of anesthesia.

- The choice of the optimal antibiotic for prophylaxis should be based on the knowledge of the most probable infectious agents in each specific situation. If possible, use one antimicrobial.

- It is prohibited to use antibiotic for prophylactic purposes within 12-24 hours from the start of the operation. A single administration of the antibiotic gives the same efficiency as the administration of several doses, if adequate concentrations of the serous preparation are maintained throughout the operation.

The management of the preoperative antibiotic prophylactics is allowed in the surgical interferences connected with the implantation and if the patient has the risk factors of the development of the infections requiring the prophylactic prescription of the antimicrobial preparations. 

The preparation of the patient before the operation of the dental implantation includes general regulations in surgical interferences.

The patient should rinse the mouth with the solution of chlorhexidine during one minute before the implantation for creating of the relative aseptic in the oral cavity.

If there are teeth subject to removal, on the place of which later it would be necessary to locate implants, two opportunities can be used:

to remove the tooth and immediately conduct the implantation or to remove the tooth, wait for no less than 6-14 weeks and only then to conduct the implantation. In the second case, it is recommended for the time of recovering of the hole to fixate the temporary prosthesis with the artificial tooth going inside the hole and it is necessary to free the marginal papilla from the pressure of the artificial tooth. 

Advantages of immediate implantation:

• the patient will not need to undergo another surgical procedure;
• most often there is no loss of height and width of the bone tissue after tooth extraction;
• you can get a good aesthetics of the gingival margin;
• the correct position of the installed implant for obtaining aesthetic restoration;
• the ability to install the implant of maximum diameter and length.

Disadvantages of immediate implantation:

• The presence of a hole makes it difficult to install the implant at the right angle;
• Insufficient amount of soft tissue to close the implant;
•  increased responsibility for the operation due to the frequent need for augmentation around the implant using bone membrane, bone and gum graft.

There are different opinions, which method is more preferable. When choosing, the individual conditions of the patient’s oral cavity, the wishes of the patient, the possibilities of the clinic, the experience of the doctor, and much more, are crucial.

OPERATION OF THE INTRAOSSEOUS IMPLANTATION

Methods of the dental implantation

The operation of the implantation can be divided on the few following stages:

• the check of the order of the necessary instruments and equipment;
• the sterilization of the necessary instruments, equipment and the room and the preparation of the patient to the implantation;
• rinse your mouth with a 0.2% chlorhexidine solution for 2 minutes;
• performing anesthesia;
• lifting the mucosa flap and exposing important anatomical areas, such as, for example, the mental foramen;
• marking on the osseous with the help of direct or round surgical drill of the desired place for the implantation;
• the primary preparation of the osseous to the depth less than planned;
• introduction of the length meter and making of the control detailed radiogram;
• the continuation of the preparing with the first drill up to the desired length after the control radiogram;
• the continuation of forming of the osseous lodge of the implant with the next drills in accordance with selected kind of the implant;
• the installation of the length meter in the osseous lodge of the implant and making of the control radiogram;
• the installation of the implant;
• the closing of the implant by the cover screw by techniques two stage or closing by the gingival format or by the techniques one stage;
• suturing the gum mucosa;
• radiograph after implantation (panoramic or dental);
• observation after implantation surgery;
• opening of the implant with a two-stage implantation method.

Local anesthesia is applied to the desired areas of the jaws using generally accepted methods. It is necessary to use an anesthetic with vasoconstrictors for hemostasis and improve anesthesia.

 Additionally, other methods of pain relief according to indications.

Bone preparation and installation of implants:

Preparing the site for the implant

Make incisions to expose the surgical site. Elevate the mucoperiosteal flaps. A minimal incision or perforation of the gums using mucotomies is recommended. Maintaining maximum bone-mucosal contact increases the success of the operation, reduces postoperative complications and swelling, minimally injures the patient and reduces treatment time. In this case, an important condition is: - the incision and height of the flap should provide easy access and control over the implantation sites, as well as ensure satisfactory registration of the morphology of the jaw; - fully see the configuration of the bone from the vestibular, lingual (palatal) side and the alveolar crest; - prepare the site and position the implant so that there is at least 2.5-3 mm of bone around the implant; - install the implant without damaging the vestibular or lingual (palatal) bone wall; - install the implant at the level of the alveolar ridge; - when inserting an implant, there should be no soft tissue around and in the bone hole - which can cause the formation of a fibrous capsule around the implant and its rejection; - when inserting an implant, the bone hole must contain fresh blood or be empty, but in any case not a blood clot (conditions for osseointegration of the SLA implant surface).

Bone preparation

Tools for bone preparation and installation of implants with a diameter of 3.75; 4.2; 5.0; 6.0; 8.0 mm, which is comparable to other systems with an H2.43 mm hexagon socket (Zimmer, Green, Direct, MIS, Alpha Bio, Pal top, Bio Horizon, etc.).

Preparation of the bone implant site depends on the type and volume of the jawbone, the method of dental implantation and the type of bone drills. The implant site is prepared in a sequential manner using drills of increasing diameter with indicator lines to determine the desired drilling depth.

Drills should be replaced when their cutting efficiency decreases. It is recommended to change drills after 30-50 drillings. When the cutting efficiency of a bone drill decreases, undesirable complications arise: - large collateral swelling of soft tissues; - severe postoperative pain; - an increase in dead bone cells in the prepared bone bed of the implant and, as a result, implant rejection; - drill fracture; - crack or chipping of the jaw bone, etc.

All bone tissue preparation should be carried out under copious cooling of the drill and jaw bone with sterile and cold saline and using the intermittent drilling technique. Intermittent drilling technique: the drill enters the bone and passes 2-3 mm into the depth of the bone. Next, you make the opposite movement - the drill comes out of the bone. The cut bone comes out of the bone hole along with the drill; it must be removed with a suction. Next, the process is repeated until you get the planned drilling depth and diameter.

Surgical drills come in cylindrical or conical shapes with internal and external cooling. When preparing the bone bed of an implant, it is necessary to take into account the type, length and diameter of the implant planned for installation, the type and density of bone, implantation technique, the type of planned restoration on implants, the condition and location of adjacent teeth, the condition of antagonist teeth, the condition of the patient’s masticatory muscles, age, factors risk and the patient's wishes.

Drilling sequence:

For reliable preparation in case of pronounced vertical resorption, surgical kits with drill stops are used. The surgical kit for dental implantation (420030) has special stops that are fixed on standard cylindrical drills and determine the drilling depth. Stops are produced for a drilling depth of 5.0/6.0/7.0/8.0/10.0/11.5 mm. 

Another kit, a surgical kit for short implants (420050), has 30 cylindrical drills with built-in stops for a drilling depth of 5.0/6.0/7.0/8.0/10.0 mm. 

Preparation begins with marking the bone with a spherical bur (173419) to a depth of 2–3 mm. Next, the bone is prepared with a 2-mm drill with a stop installed on it. After preparation with the first drill, it is necessary to install a titanium depth gauge to the depth specified by the stopper and, in parallel with it, perform an X-ray examination in the prepared hole - a periapical (target) or panoramic image. (shortened titanium depth gauge (451030) to determine the depth and parallelism of the implant bone preparation during surgery). 

Considering that the thread pitch on the template is 1 mm, it is possible to determine with high accuracy how far we are from the nerve trunk, tooth, etc., and also to determine how parallel the drilling is in relation to the teeth, implants, etc. And only then carry out further preparation of the implant bone bed. If it is necessary to install several implants

It is recommended to maintain a minimum distance of 3.5 mm from each implant to the next. To accurately determine the interval and parallelism of placement, use Parallel Gate (450023). 

During the drilling stage, it is necessary to constantly inspect and examine the bone socket or the socket of the extracted tooth. For this purpose, an implant depth gauge (450001) is used, which is a pen with a double-sided working part. 

Using this depth gauge allows you to simplify the inspection of the walls and bottom of the prepared bone bed of the implant, determine the presence of perforations in the walls and bottom of the bone bed, and determine the integrity of the bone bed. mucous membrane of the maxillary sinus, measure the height of the alveolar process to the bottom of the maxillary and nasal sinuses on the upper jaw and the mental foramen on the lower jaw, take the necessary measurements during the operation and choose the tactics for further actions. Then drilling is continued with drills with a stopper with an increase in the drill diameter. The last drill should be 0.5 mm smaller than the implant diameter.

Drilling protocols with cylindrical drills are considered classic. 

When preparing D1 and D2 type bones with cylindrical drills, it is recommended to use additional drills to widen the implant entry hole in the bone with special countersink drills. 

This ensures smoother and easier insertion of the implant into the bone, allowing for complete integration and immersion of the implant into the bone. This also prevents complications such as: - bone overheating, - bone fracture, - implant hex fracture, - jamming of the implant carrier or implant driver key in the implant hex.

Protocol for dental implantation using cylindrical drills depending on implant diameter, bone type and dental implantation method:

The implant is installed

The implant is installed using a 2.43 mm Allen key. The keys have high edges that help visually determine the position of the implant hexagon. It is recommended to place the flat part of the facet on the vestibular side so that standard abutments can be used. Additionally, the keys have two circular marks indicating the depth of implant immersion relative to the bone: the gum mark is at 3 mm, and the second at 5 mm. 

After installing the implant and removing the implant carrier, it is necessary to close the internal connection of the implant.

There are several approaches:

1. Two-stage implantation - installation of a cover screw, which is in the sterile implant kit. Using a 1.25 Allen key (431212, etc.), take a screw from the sterile package and screw the cover into the UNIQUE titanium implant and slightly tighten it. Next, we perform hermetically sealed suturing of the gum above the implant with a plug. At the second surgical stage (5-6 months after implantation), it is necessary to make an incision in the gum above the implant, lift the gum, remove the closing screw, install the former and suture the wound. Prosthetics on implants can be started in 3-4 weeks. 

2. One-stage implantation.

The titanium gum former for implants with an internal hexagon H2.43mmd is installed on the implant immediately after the implant is installed in the bone. The titanium gum former is made of medical titanium alloy Ti6Al4V ASTM-136. The abutment diameter is from 3.0 mm to 6.0 mm. (Fig. 24) The outer surface is smooth. At the end of the gum former, there is a hexagonal recess for a hexagonal key with a diameter of 1.25 mm (431212, etc.). At the lower end of the gingiva former there is a screw with a 1-72.UNF thread. It is used to cover the internal connection of the titanium implant in order to form a gingival collar over the implant. The height of the abutment is selected based on the thickness of the gingival margin in each clinical case. It is recommended: the height of the gingiva former should be higher than the gingival margin by at least 1 mm, and the gingiva former should not come into contact with the antagonists and adjacent teeth. Before use, sterilization in an autoclave at a temperature of 135 ° C / 274 ° F is required. Prosthetic restoration on implants can be started no earlier than 5-6 months later. 

For prosthetics on osseointegrated short implants only fixed (screw and cement) restorations are available. Special transfers for short implants are used for taking impressions. Abutments for short implants use special short screws (701206, 701207). They are purple. Prosthetic parts are comparable with other systems with an internal hexagon of 2.43 mm and internal thread 1-72 UNF implants (Zimmer, Direct, MIS, Alpha Bio, Pal top, Bio Horizon, Green, etc.), but using screws for short implants.  

Purpose and recommendations:

In the morning or an hour before dental implantation, take 1-2 tablets of Augmentin 500 mg and then 1 tablet of Augmentin 500 mg x3 four times a day for 7-14 days. If bone tissue is also expected to be built, then add Metrogyl 250 mg, 2 tablets 2 times a day for a week. When installing more than 3 implants and/or additional bone grafting, it is additionally recommended to prescribe Dexamethasone 2 mg according to the following regimen: 5 tablets on the first day, 4 tablets on the second day, 3 tablets on the third day, 2 tablets. pills. tablets on the 4th day, 1 tablet on the 5th day. Mouth rinsing should begin on the second day after surgery according to the following scheme: - rinses containing chlorhexidine for 10 days for an antimicrobial effect, - and then rinses, but not containing chlorhexidine and not containing alcohol, preferably with the effect of restoring the gum mucosa.

Disclaimer:

DMi, the importer and supplier of DMi products shall not be held responsible for complications, other negative consequences or damages that may arise due to reasons such as incorrect indications or surgical technique, incorrect choice of implant

or handling, improper use or handling of instruments, etc. The dentist/oral and maxillofacial surgeon is responsible for any such complications or other consequences. The dentist/oral and maxillofacial surgeon must properly instruct and inform the patient about the operation, handling and necessary care of the device, as well as any known risks associated with the device.

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