Instructions of use
MSDI DENTAL IMPLANTS SPIRAL IMPLANT AND RELATED PROSTHETIC PARTS INSTRUCTIONS FOR USE
- MSDI Dental Implant system is a high-technology system which uses the properties of self-tapping implants.
- In order to assure its tissue and osseous tolerance, MSDI Dental Implant system is implantable Titanium alloy grade V in compliance with the standard ISO 5832-3.
- A warned and formed practitioner to implantable technics should always do MSDI Dental Implant system placement. The absence of practitioner’s adequate training induces a major risk for the success rate of dental implants and can even compromise the state of general health of the patient
- MSDI Dental Implant system is used in association with specific related prosthetic parts manufactured by MSDI.
These prosthetic parts must not be substituted by references not manufactured by MSDI.
Any use of prosthetic material and/or ancillary not validated by MSDI pull de facto the loss of the manufacturer’s guarantee.
- Invasive and implantable parts of the MSDI system are single-use devices and must not be reused.
Any re-use of a single-use device induces a significant risk of infection for the user and the patient and a loss of the mechanical properties of the implants and the prosthetic parts.
- For the implementation of the dental implants, it is imperative that the practitioner followed a specific training course in implantology to master the different elements to be implemented by taking into account anatomical constraints of the patient.
- The environment of use of the MSDI during the intervention has to answer the rules of standard asepsis.
- All the single-use components and the non sterile delivered instruments must be cleaned, disinfected and sterilized according to a validated method before entering the mouth of the patient.
Our implants have been designed so that their sterile state should be maintained. Make sure the implant does not come into contact with contaminants once it is removed from its packaging.
MSDI Dental Implant system is composed of a self-tapping dental implant, an implant holder and a cover screw.
MSDI Dental Implant system and related prosthetic parts are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient chewing function. MSDI Dental Implant system and related prosthetic parts are also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The presence of the bone and its capacity to support the implant must be estimated from radiographies of the zone of implantation, according to the current techniques for the realization of false teeth.
Also it is necessary to study very carefully the location of blood vessels, maxillary sine, nasal cavity, cavities in mild parts, as well as their relation in the zone of setting-up.
1. Disinfect the implant site
2. Marking the bone according to the planning of the established intervention
3. Preliminary drilling before the implant insertion: the insertion of the implant has to respect a surgical protocol including a sequence of drilling adapted to the clinical case and to the osseous criteria of the patient.
4. Insertion of the implant: do not exceed strength of 60N during the insertion of the implant
5. Screwing of the cover screw supplied with the implant or of a healing cap.
General contraindication to oral surgery and jaws are applicable in case of dental implantation. Applicable contraindication also include :
- The patients handled by radiotherapy or subjected to diverse immunosuppressive therapy. These treatments could be responsible in the reduction of the success rate of dental implants
- For bisphosphonate therapy and implant surgery, the duration, route, and the dosage of the medication, as well as the type of bisphosphonate are reported to play an important role in potential bisphosphonaterelated osteonecrosis of the jaws.
- The consumption of oral biphosphonates by patients who suffer from osteoporosis seems to be a partial contraindication for the treatment with dental implants and the patient must understand the necessity of a longer follow-up period so as to detect any sign of bone chemical necrosis
- Risk is increased if the case of patients receiving treatment with ciclosporin, azathioprine or similar, corticoids or hormonal therapy, in this case it is an absolute contraindication. The patients suffering from diabetes, cardiac and lung diseases also are to be watched. Dental implants will not be either placed in patients whose implanted site are under osteolytic, inflammatory or infectious activity.
OTHER CONTRAINDICATION :
- The consumption of tobacco seems to be a factor associated with the increase in the loss of dental implants; failure rate around 2.5 times higher in patients who smoke are reported.
- Processes, diseases or care compromising the therapeutic capacity (low motivation of the patient, psychiatric disorders preventing the patient from understanding and from interiorizing the necessity of implant placement, unrealistic expectations of the patient, impossible prosthetic reconstruction).
- Incapacity of the patient to manage his oral hygiene.
- Hypersensitivity of the patient in the specific components of the implant.
The risks associated to this surgical operation can be divided into four categories:
1. Immediate risks related to the anaesthesia and the surgery procedure.
2. Risks related to psychological or psychiatric problems
3. Long-term medical complication
4. Permanent impact of the implant on the patient health
Among these possible risks, it is possible to indicate: drilled by the nasal cavity and by the maxillary sine, the local and systematic infection due to a breakthrough in the cavities of mild parts, reached by the nerve.
Temporary phenomena resulting from the insertion of the implant such as: pain, swelling, speech disorders and inflammation of the gums.
The following long-term problems can also appear: damaged nerve, local or systemic bacterial infection, infectious endocarditis in sensitive or post-transplantation individuals. The incorrect placement of an
implant can damage the natural set of teeth.
The practitioner must inform the patient that the safety and/or the durability of the placement of an MSDI Dental Implant system are function of its activity and of the respect for the advice, which will have been given. The
practitioner will inform the patient of the potential unwanted effects consecutive to the dental implant placement (osseous split, infection, pains, bruise, oedema, temporary or permanent nerve damage, bleeding, oral drought, sinusitis). Patient’s informed consent must be obtained before surgery.
After dental implant placement, the patient will have to inform the practitioner of any sensation or modification appearing at the level of the SPIRAL IMPLANT.
PROSTHETIC PARTS AND ANCILLARIES
- The instrumentation of insertion as well as the prosthetic components (abutment, attachment ball, healing cap) must be cleaned and sterilized in the autoclave (minimum of 18 minutes at 134°C) before use.
The process of sterilization must be validated by the user according to a method recognized by the authorities of the product country of use.
- MSDI Dental Implant system is sold sterile (gamma sterilization) in unit package. A witness label affixed on the packaging indicates the actual passage of implants in irradiation. The sterility is guaranteed 5 years (from the date of sterilization).
Only an intact packaging guarantees the sterility of the products. Do not use implants with damaged or prematurely opened package.
- Every packaging, besides the product reference, contains self-stick labels resuming all the specifications of the implant (lot number, sterilization, best before date, etc.) which are to be affixed on the patient file.
- Implants and prosthetic parts must be stored in a clean, dry, fresh and appropriate place.
- BRAT dental implants and prosthetic components are single-use devices. Never reuse an extracted and/or rejected implant.
The re-use and/or the re-sterilization of any implant and prosthetic components can be at the origin of infectious disorders of the user and the patient.
ELIMINATION OF WASTE
The single-use soiled elements are considered as bio-hazardous waste. They must be collected and handled according to the applicable national regulations.