The Surgical Procedure and the use of the products of the LEONE Implant System described in the following pages are intended for Professionals experienced in dental implant techniques.
In case of lack of basic notions, we suggest to attend specific courses in order to reach a high level of knowledge and practice in the use of implants. The rules on the use of the products described below represent a group of standard instructions that must be adjusted to the single needs and to the particular situations that may occur according to the manual ability, to the experience and to the diagnosis made by the legally qualified medical operator. It is not ascribed to the manufacturer the duty of monitoring the procedures of use of the product. A correct and appropriate use of the instruments and products related to the LEONE Implant System shall completely be reverted to the clinician. The surgical procedure hereunder described is merely indicative as any single treatment case is assigned to the experience of the operator. As every medical operator well knows, a correct procedure and a perfect manufacture of the prosthesis may sometimes be followed by not satisfactory results owing to particular situations not imputable to responsibility of the dental operator or the manufacturer.
Implant therapy is indicated in the treatment of the following conditions: SINGLE-TOOTH EDENTULISM, DISTAL EDENTULISM, MULTIPLE EDENTULISM, TOTAL EDENTULISM.
For contraindications and side effects read the instructions for use enclosed in the package of each product and available in our web site www.leone.it.
Before starting the surgical intervention, the patients have to be subjected to a series of exams; single cases have to be evaluated in the opinion of the clinician.
It is the first approach to the patient and it represents a fundamental tool to recognize both risk factors and contraindications. Moreover, anamnesis allows for the evaluation of patient’s expectations and priorities and of patient’s degree of compliance and motivation. Anamnesis can help in evaluating the need for extra exams in addition to the routine ones (when the presence of pathologies that were not reported by the patient is suspected) and when particular situations drive to deem a complete medico-surgical exam necessary.
It consists of:
- inspection of the periodontal tissues, of the oral mucosa and of the teeth along with an initial evaluation of the occlusal relationships (skeletal Class, characteristics of the opposing arch and related potential problems, type of occlusion, interarch distance), of the presence of parafunctions, of the degree of oral hygiene, of the aesthetic conditions, of the morphology of the edentulous crest and the space available for the replacement of the prosthesis.
- palpation of the soft tissues and implant sites with a first evaluation of the bone morphology and thickness.
- a complete periodontal probing for the appraisal of the absence of both gengivitis and pockets.
- Examination of the dental casts mounted in an articulator for a comparison with the information derived from previous exams, creation of a diagnostic set-up, and, if necessary, the implementation of a surgical template.
PANORAMIC RADIOGRAPH: frequently, this radiograph enables to appraise bone height and the relationships between implant site and adjacent structures, such as maxillary sinuses, nasal cavities, and mandibular canal. It is also possible to identify concavities and ossification defects due to previous tooth extractions.
INTRAORAL RADIOGRAPH: it is very helpful for the determination of the mesio-distal distance between the roots, and the apico-coronal availability of bone.
LATERAL CEPHALOGRAM: it is useful when interventions on the mandibular symphysis are planned.
COMPUTERIZED TOMOGRAPHY: it is advisable to remind that previous radiographic exams provide two-dimensional images which do not give information on bone thickness. In order to obtain this useful information a computerized tomography is necessary: it provides three-dimensional images, thus allowing for an accurate evaluation of bone morphology and, sometimes, bone density.
Instrumental or laboratory exams or medical advices
When necessary, in cases where a pathology is suspected on the basis of anamnesis or clinical records.
The number and dimensions (diameter and length) of the implants to be seated are determined by the following factors:
- amount of bone available
- characteristics of the implant site
- masticatory load
- aesthetic results
- type of the prosthetic restoration
- type of the surgical procedure followed
Further and particular single situations must be evaluated by the clinician.
Templates (page 39) are available showing all LEONE implants in actual dimensions, with dimensions increased by 10% and increased by 25%, to match possible distortions created by the instrument for radiographic examinations (CT, panoramic radiograph, standard and digital cephalograms). Superimpose the template to the radiograph in order to select the implant in relation to the quantity of bone available.
Do not seat a single Ø 3.3 mm implant in molar position.
The Ø 3.3 mm implant, length 8 mm, must be used as a supplementary implant in the prosthesis composed of two or more implants of any diameter and length.
The LEONE 6.5 short implant is intended for use only in cases with limited vertical bone availability. It is not intended to be associated with sinus lift procedures.
Do not place the LEONE implants above the level of the alveolar crest.
The LEONE implant system is characterized by a high mechanical resistance validated through fatigue strength testing according to the ISO 14801 international standard, which indicates to perform testing with a cyclic loading at an angle of 30° with respect to the implant-abutment axis. For the LEONE implants of minor diameter, and thus the most relevant ones, the results are: Ø3,3 mm and Ø3,75 mm implant fatigue strength: 240 N; Ø4,1 mm, Ø4,5 mm and LEONE 6.5 short implant fatigue strength: 392 N.
In the literature, in comparison, it is reported that the average force generated during mastication is 145 N with inclinations up to 10°. It should also be underlined that very high masticatory forces can be generated due to many individual and prosthetic factors, such as crown height, cantilever and restoration type,which locally can exceed the strength limit of the implants, especially in case of single or unsplinted implants.
SURGICAL KIT AND ORGANIZER
The surgical kit, (page 40), completely autoclavable, contains all the necessary surgical instruments for the implant treatments with the LEONE Implant System.
To simplify the surgical operation, a surgical kit with reduced dimensions, an organizer (pages 42-44) was conceived by LEONE to sterilize and hold the necessary instruments on the operation field.
The organizer is fully autoclavable and it can contain up to 8 instruments on colour coded special supports.
Either the organizer or the surgical kit must be wrapped and sterilized before use.
The sterilization must be done as follows:
- wrap the organizer or the kit into a sterilization bag as requested by the manufacturer of the sterilizing machine;
- autoclave at 121° (250°F) for 20 minutes;
- remove the organizer from the autoclave and leave it cool inside the bag;
- leave the organizer or the kit inside the bag to preserve sterility
LEONE IMPLANT PACKAGING
THE GLASS VIAL