product information Q&A
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Frequently Asked questions
Q. What are the dimensions of the Sendax MDI Mini Dental Implants?
A. IMTEC, a 3M Company offers four MDI implant lengths. The company’s standard thread MDI's are available in lengths of 10mm, 13mm, 15mm and 18mm and are available in 1.8mm, 2.1mm and 2.4mm diameters. The 2.4 MAX thread implant is designed for Type II or III bone. The wider thread design enables it to bite deeper into the host site. The MAX thread design will better engage very cancellous or marrow-filled bone primarily in the maxilla, but also in other locations where the bone may strip more readily and provide poor anchorage. These implants are made of high quality titanium alloy, consisting of Ti-6AL-4V. In fact, a 1997 test study at the University of Alabama at Birmingham clearly established that the MDI titanium alloy implants the company sells are much stronger than CP titanium products. More recently, the company commissioned a torque and dynamic loading study from the Medical College of Georgia at Augusta, which concluded that after 5,000,000 cycles of force, each ranging from 13 to 134 N at a sinusoidal rate of 8Hz, there were no changes detected in the submitted 1.8mm x 15mm and 1.8mm x 13mm MDI’s, and furthermore, no fractures. Copies of both reports are available upon request from the company.
Q. How about single tooth replacement?
A. MDIs work very well as single tooth replacement implants where there is insufficient space between tooth roots for a conventional implant. Since the implant system is approved for marketing by the FDA for both transitional and long-term applications, it can be considered a long-term implant if the patented insertion protocol is followed explicitly.
Q. I know fees vary greatly by region, but could you give me an idea of the fees currently being charged for placement of four MDI implants and modification of an existing complete denture?
A. Fees do vary greatly, and a lot of factors come into play. Clinicians at seminars talk about fees ranging from $250 to $750 per mini-implant depending on all the usual factors clinicians are accustomed to. Incidentally, an excellent article about substantial increases in clinicians’ incomes after their electing to place the MDI was published in the October 2000 edition of Dental Economics. Dr. Eddie Gillespie authored that article. Reprints of the piece are available from IMTEC and I recommend any clinician interested in substantially increasing annual clinic income to secure one. There are a lot of positive things about patient satisfaction regardless of the fees charged.
Q. I just placed my 16th MDI and everything went well once again. To me, the MDI’s are almost scary. They’re so easy! Plus my patients LOVE them. I’ve been charging $500 per implant and another $200 to pick up the O-Ring into the denture (per implant). My practice is located in a Boston suburb. Am I charging fairly? I can place two MDI’s and pick up the O-Ring in about ninety minutes start to finish.
A. Of course it’s fair as long as the patients think so too. However, I would note that we always recommend a minimum of four MDI’s in the mandible.
Q. How long can I predict to my MDI patients that their mini-implants will last?
A. All implants, including MDI’s, will last as long as they remain bone-integrated
without mobility or infection. MDI’s are the only implants on the market
that can be deemed integrated immediately after insertion due to their
unique, patented, insertion protocol. Operating as a minimally invasive,
totally self-tapping procedure, an MDI does not require a conventional
osteotomy to ream out a considerable amount of bone which then must be
regenerated into contact with the implant surface before supportive integration
can reasonably be expected. Histologic human studies from Temple University
Dental School have confirmed that MDI’s demonstrate direct bone contact
without any intervening soft tissue, and, most importantly, ongoing clinical
experience has shown the ability of an integrated MDI to be able to bear
functional intra-oral loading without loss of integration. However, all
implant systems can potentially lose their bone anchorage from occlusal
overloading especially during habitual bruxism and other para-functional,
non-physiological activity, as well as local and systemic disease. Smoking
has also been shown to be a prime negative factor in connection with osteoporosis
and peri-implantitis, leading to greatly increased likelihood of implant
failure.
Continuing, if you use only a minimal starter cortex penetration and then
only 3 to 4 millimeters into underlying medullary bone, you’ll find that
the MDI device auto-advances into the remaining bone until it is rock solid.
This totally self-tapping, virtually non-surgical insertion protocol will
provide immediate integration without an intervening healing period. That
is the core rationale for any assumption of MDI longevity.
No one can simply claim longevity. A clinician must gradually develop the
essential “comfort level” required. You’ll quickly find the MDI works not
only for short-term but long-term, on-going applications as well.
Continuing on this important and frequently asked question, for implants
in general, as well as Sendax MDI’s in particular, there should be no explicit
cutoff date for implant survival if the implants are in direct bone contact
support (osseo-integrated in the so-called Brånemark definition), or as
we prefer to call it: OSSEOAPPOSITIONED, since direct bone contact with
MDI threads occurs immediately upon auto-advancement insertion, rather
than by the slow healing and bone regrowth/repair process characteristic
of conventional implant systems.
Q. Please comment on the MDI system’s applicability for provisional use.
A. After placing O-Ball mini-implants you can easily retrofit an existing maxillary or mandibular denture (or bridge) by hollowing out the acrylic for relief over the mini-implant(s) and then following up with a soft chair side liner which, when set, will provide moderate anchorage without compromising the MDI’s bone support. After you have attained your own comfort level with the system’s ability to be put into immediate function, you can switch over to the more secure O-Ring retention attachments, which are included with each O-Ball MDI. You might also be thinking about O-Rings for medium and longer-term use, rather than only as a short-term, transitional solution, but that will come about naturally in the course of your familiarity and experience with the entire MDI insertion and reconstructive protocol.
Q. Should I use a standard Informed Consent office form with my MDI patients?
A. We recommend an Informed Consent form that is somewhat tailored to the MDI procedure. Upon request, IMTEC will fax or e-mail you a complimentary Informed Consent form that can be customized to fit your clinic’s needs. However, you should consult with your own legal counsel before using any particular consent form.
Q. I understand there is a Sendax MDI kit available. Tell me about it.
A. IMTEC’s MDI kit, part #S1803 features (5) 1.1 mm surgical drills, MDI finger driver, MDI winged thumb wrench, ratchet wrench, ratchet adapter, ratchet extension, (25) block out shims, MDI surgical box, one pair of titanium locking pliers, Secure hard pick-up kit, Secure dispensing gun, (5) surgical intra-oral skin markers, (3) ACCESS toothbrush bristle density #1, (3) ACCESS toothbrush bristle density #2, (3) IMTEC Dry Field System - Large, (1) IMTEC Dry Field System - Small. Full line pricing information is available from the company. Online orders are welcome at www.imtec.com.
Q. How important is the strict following of the recommended insertion and reconstructive protocol? Also, please comment on fracture rates.
A. The protocol is critical. Long-term experience has demonstrated a consistent record of safety and effectiveness of the original concept that these devices, when placed utilizing a strict insertion and reconstructive protocol, have the ability to function both for transitional and long-term applications. As for fractures, they’re totally minimized when the titanium alloy (Ti6A14Va) is utilized instead of CP titanium. Records of clinical trials have proven that the optimal resistance for final seating of an MDI Implant is 35 NCm. Any value beyond 45 NCm could result in a fracture of the implant. Lateral forces placed on the implant during insertion can also cause fracture. Both can be controlled by the careful clinician.
Q. Have any independent agencies or groups researched the 1.8mm diameter implant and reported their findings?
A. Yes. Clinical Research Associates of Provo, Utah, a nationally recognized research organization headed up by Gordon J. Christensen, DDS, MSD, PhD., in Vol. 25, Issue 1, January, 2001 of CRA Dental Products Buying Guide, entitled Trends Evident From Outstanding Products Studied in 2000 states: “...... 9. Mini implants [less than 2mm diameter] are increasing in use for patients with minimal bone. They can provide both excellent transitional & long-term service.” (Emphasis CRA) Incidentally, Dr. Christensen demonstrates the Sendax MDI in one of his excellent teaching videos entitled The “Mini” Implant for General Practitioners (Item C900A) that is available at 800/ 223-6569 or over the web at www.pccdental.com.
Q. Your mini implant system is called MDI. There is also an "MTI" on the market. What’s the difference? Comment on that and also what about copings that the lab technician can wax and cast to?
A. MDI is the
marketing brand that describes IMTEC, a 3M Company’s Sendax mini dental implant
system. “MTI” is a term used by Dentatus USA. MTI stands for “modular transitional
implants.” Its unclear what “modular” means in this context. I would speculate
it refers to that company’s prosthetic system.
I can’t comment effectively about the Dentatus MTI’s components since the
IMTEC Sendax MDI system is totally different both as to insertion and restoration.
As to the MDI system, whether it has a rectangular prepable head or incorporates
the newer O-Ball abutment head, no prefab metal or resin copings are supplied
owing to potential angulation and path of insertion (“draw”) problems that
could complicate rather than simplify prosthodontics. IMTEC’s approach
is to supply clinicians with special elastomeric shims which will act as
spacers for any lab technician wax-ups and castings, and which greatly
simplify the entire process. After taking Polyvinylsiloxane (or equivalent)
impressions and placing IMTEC analogs (root formers) into the set impressions,
a model is poured. The elastomeric shims are inserted over the analogs
in the model and wax-ups are then lab customized for each specific application.
Q. I have reviewed the Sendax MDI system and am impressed. I have an 85-year-old female patient with substantial bone loss. I’m enclosing her panoramic X-ray. Please comment as to her eligibility for the MDI system. Also, she’s asked ...is this treatment permanent? What should I tell her?
A. This should be an ideal case for the Sendax MDI implant system. I’ve reviewed the panoramic X-ray of your patient and it reflects that the anterior mandible (symphysis region) seems to have adequate bone for the MDI implants. Since this is a minimally invasive system, it should be safe and effective for her. As for your patient’s question about permanency, as you know nothing in the world is “permanent”, so I counsel clinicians to never use that word in describing dental care in general or implant care specifically. But, as to basic durability the FDA has granted clearance to market the Sendax MDI for transitional and long-term applications. That essentially means as long a term as a patient requires. That should cover any short, medium or long-term uses you may have in mind for the MDI’s. For that elderly patient, I would say you have a particularly good prognosis.
Q. I attended the late Dr. Charles English’s MDI seminar in Chicago and have a primary concern: How much torque will the mini dental implant withstand? I am aware that there is a learning curve here, but some subjective guidelines would be helpful. There were several instances of broken implants in the seminar class while using a wood medium. Is a broken implant a common mistake, or were we just being ”ham handed”? What do I do in event of a sheared mini? Finally, I do not use a water cooled low speed hand piece in my clinic. Is this essential, or is a conventional low speed unit with a light touch acceptable? Forgive the elementary questions, but I am eager to stabilize those dentures I made many years ago. This is an exciting concept that I find very attractive. I have practiced for forty-five years and have resisted, up until now, learning anything about implants; however, this idea is irresistible. Congratulations on developing such an invaluable contribution. I learned of it from Dr. Christensen a while back.
A. Mini
implants inserted in dense wood technique blocks should be placed with
care since wood does not have a comparable level of visco-elasticity as
living bone and may indeed make the MDI’s more vulnerable to fracture than
in typical cancellous bone environments. Most fractures in living bone
typically occur when the tip end of the implant gets apically embedded
in very dense Type I bone and is over-instrumented by use of excessive
force in an attempt to seat an over-long implant fully up to its abutment
neck. A more realistic approach is to simply back out the implant and use
the next shorter length MDI that should then be readily insertable without
exerting extreme torquing forces. Final ratcheting should only be used
for a few turns to provide a rock-solid MDI and with distinct recovery,
pauses between ratchet turns.
As to drilling equipment, low or high speed can work equally well with
assistant directed or internal water spray, both effective, considering
the fact that only a very brief minimal “starter” opening is required to
gain a self-sustaining purchase for the auto-advancing MDI.
As to any broken titanium elements left in the jawbone following fractures,
it is rarely necessary to trephine out such tiny, benign elements since
they are best left behind and readily assimilated.
Q. Are MDI patient education brochures or pamphlets available? How about training?
A. Yes. Two patient education brochure have been produced by IMTEC, designed to be mailed or handed to prospective MDI patients, as well as a pamphlet entitled "A Patient’s Guide to Mini Dental Implants." They’re available from the company and are great practice builders. Also, a nice promotion poster for the dentist’s reception area has been produced. It’s likewise available. As for training, MDI training is highly recommended. IMTEC sponsors numerous one-day clinics with hands-on features that have been well received. I also have a limited number of mini-workshops at my clinic in Manhattan throughout the year. The company can furnish seminar and enrolling information to you upon request.
Q. May I e-mail technical questions directly to you?
A. Absolutely. Note the address vis@sendax-minidentimpl.com for your e-mail inquiries or comments that are welcome. In most instances I’ll respond directly to you the same business day. Technical questions and support are always available from IMTEC, a 3M Company.
Q. I’m a Canadian doctor. Is the MDI approved here?
A. Yes. The Canadian government has approved the MDI for transitional and long term.