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Mini Dental Implants are not FDA approved to use for crowns…or are they?

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Where is this coming from?  Why would we as dentists want to misinform the very patients that seek our help?  If we don't know the answer its best to tell the patient I don't know.  We should say, if you are considering getting this procedure with mini dental implants you ought to seek out a dentist that does a lot of them.   I think it would be better to let our patients know the truth and let them make decisions for themselves on how they want their mouth taken care of.  In the end its their health, time and money….not ours. 

To answer the question do Mini Dental Implants have FDA approval to use long term for crowns or dentures… YES they are.Mdi approval_Page_3

 

Image of the 510(k) approval from the FDA, straight from their website stating in plain English that mini dental implants (IMTEC MDI) are approved to use for however the dentist sees fit; long term or short term.  IMTEC MDI is the substantial equivalent that most other, if not all other manufacturers have applied to get their FDA approvals. 

  Does being FDA approved mean anything?  Well it means something, but as with any medical device you have certain risks and benefits.  If we as dentists are going to try and take the position that traditional implants are FDA approved and minis are being used outside of their prescribed approval then that is just wrong and means nothing.  They are both approved to use in the mouth.  Do they both work…yes. Do they both have the potential to fail…yes. 

They both have about the same success rate (anywhere from 96-97% success).  You can make any study look good for the parameters you want it to….but in everyday wet fingered dental offices you will find this number to be correct.  A skilled traditional implant dentist and a skilled mini implant dentist will have around the same success ratios. If anyone tells you they have a huge failure rate with minis then they just have not got the proper training….just like if someone tells you that traditional have a huge failure rate in their hands….you may wish to see the help of someone else. 

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FDA 510(k) approval for a Intra Lock Mini Dental Implant Prosthetic Abutments in plain English showing approval for use in either upper or lower jaws for a removable (denture) or fixed (crowns and/or bridge) prosthesis. You can see all the other major brands, OCO Biomedical mini and micro, ACE Surgical Secure Mini, etc… have FDA approval on the FDA website.

 

 

 

 

 

Paresh B Patel DDS  Dentist Mooresville NC

Mini Dental Implants

No Bone for Dental Implants ~ Would Mini Dental Implants work?

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One of the main reasons patients don't move forward with dental implant treatment is lack of bone.  This lack of adequate bone can be in the width or height dimensions. 

Thin ridge

Cone Beam CT scan showing a lower mandibular ridge with severe resorption in both the vertical and horizontal dimensions.  The ridge of bone is only 1.2mm wide at the top and stays that way for 9mm until you get to the wider bone near the chin. 

In this case we had no choice but to flatten the ridge to make room for the smallest mini dental implant we have (1.8mm wide).  Once that was done there was only 11mm of height left to place the mini implant in the lower jaw. 

Lower ridge 
 
The mouth has a very specialized kind of bone, its called alveolar bone.  This alveolar bone is not found anywhere else in the body.  Its purpose is to hold the roots of your tooth the the base of the jaws.  Once teeth are lost this bone just melts away or is resorbed by the body.  If you have a loose or ill fitting denture or partial the constant rubbing and moving will cause this bone loss to accelerate.  Even in areas of one missing tooth the alveolar bone melts away.  Without a tooth root over time the bone will be lost.  The good news is that any dental implant, mini or traditional conventional will help to keep this bone from melting away any further.  Bone loss for implants

This picture shows how substantial bone loss can be from missing lower jaw tooth molars.  The ridge of bone is thin and is vertically deficient.  Options could be to do a block onlay graft of bone or to consider using mini dental implants.  One of the benefits of mini dental implants is that we can sometimes avoid this additional surgical procedure. 

Large bone defect Area where a tremendous amount of bone has been lost in the lower jaw.  A large defect that would require bone grafting to place traditional size dental implants. 

So what should you do if there is no bone left for a dental implant?  The most elegant solution is to repair the missing bone and gum to gain the height and width that was once there.  This requires the experience and high degree of surgical skill of an experienced Oral Surgeon, Periodontist or a well trained General Dentist who does this kind of surgery on a daily basis.  We refer this kind of treatment to a highly skilled dentist in our area. 

But with every procedure there are some drawbacks.  For this kind of bone grafting or repair the potential hazards are:  prolonged healing time, additional surgery, additional temporary dentures to fit over the repaired bone while it heals, potential morbidity and expense.  There could be additional pain and discomfort or injury to the nerve.  Mini Dental Implants are an alternative to consider to bone grafting or bone augmentation.  The patient not only saves on the cost of the bone grafting (anywhere from $3000 to $6000) but we can use the mini dental implant almost immediately.

Thin ridge that needs grafting

This picture shows how thin a ridge can get.  It would be very difficult to place a traditional implant here without doing a surgical bone grafting procedure. 

 

 

Mini implant placed

 

Here we have placed a mini dental implant without any bone augmentation procedures.

 

 

 

Mini implants thin bone Mini implants thin bone 2

 

Intra Lock Mini Dental Implants in thin bone.  Here I used a 2.0mm Intra Lock mini; however just about any mini dental implant would work….other minis I use include OCO Biomedical mini or OCO Biomedical micro, IMTEC MDI, ACE Surgical Secure Mini Prep or Hiossen.

 

 

 

Crowns on minis

 

Porcelain Crowns on the top of the mini dental implants cemented in place.

 

 

 

Thin bone and nerve

 

This x-ray shows a 2.0mm wide mini dental implant.  Notice how thin the bone is…it is at most 4mm wide.  A traditional regular implant would not fit without bone augmentation(repair) surgery. The pink shows where the nerve bundle exits out of the jaw into the gum tissue.