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Dental implants are medical devices that are surgically implanted into the jawbone to restore a person’s ability to chew or their appearance. They provide support for artificial (false) teeth, such as crowns, bridges or dentures.

Background
When a tooth is lost due to injury or disease, a person may experience complications such as rapid bone loss, speech impediment, or changes in chewing habits that cause discomfort. Replacing a lost tooth with a dental implant can significantly improve the patient’s quality of life and health.

Dental implant systems consist of a dental implant body and a dental implant abutment and may also include an abutment fixation screw. The body of the dental implant is surgically inserted into the jawbone in place of the root of the tooth. The dental implant abutment is usually fixed to the implant body by the abutment fixing screw and extends through the gums into the mouth to support the attached artificial teeth.

Recommendations for patients
Before choosing dental implants, talk to your dental provider about the potential benefits and risks, and whether you are a candidate for the procedure.

Things to consider:

Your general health is an important factor in determining if you are a good candidate for dental implants, how long it will take to heal, and how long the implant can stay in place.
Ask your dental provider what brand and model of dental implant system is used and keep this information for your records.
Smoking can affect the healing process and decrease the long-term success of the implant.
The healing process of the implant body can take several months or longer, during which time you usually have a temporary abutment in place of the tooth.

After the dental implant procedure:

Carefully follow the oral hygiene instructions given to you by your dental provider. Regular cleaning of the implant and surrounding teeth is very important for the long-term success of the implant.
Schedule regular visits with your dental provider.
If your implant feels loose or painful, notify your dental provider immediately.
Benefits and risks
Dental implants can significantly improve the quality of life and health of a person who needs them. However, complications can sometimes occur. Complications can occur shortly after the placement of the dental implant or much later. Some complications lead to implant failure (generally defined as loosening or loss of the implant). Failure of the implant may result in the need for further surgery to repair or replace the implant system.

Advantages of dental implant systems:

Restores the ability to chew
Restores cosmetic appearance
Helps prevent the jawbone from shrinking due to bone loss
Preserves the health of surrounding bones and gums
Helps maintain stability of adjacent (nearby) teeth
Improves quality of life

Risks associated with dental implant systems

Damage to surrounding natural teeth during implant placement
Injury to surrounding tissues during surgery, such as perforation of the sinuses
Injury during surgery (for example, surrounding jaw fracture)
Inadequate function, such as the feeling that the teeth are not biting normally
A sensation that the tooth is loose or twisting in place resulting from the loosening of an abutment screw
Implant body failure (looseness of the implant body) due to systemic infection, which may be more likely in patients with uncontrolled diabetes
due to local infection of the bones and gums supporting the implant body
due to delayed healing, which may be more likely in patients who smoke
Difficulty cleaning the gums around the implant, leading to poor oral hygiene
Untreated periodontal disease
Post-surgical numbness due to impingement or nerve damage

Always tell health care providers and imaging technicians that you have dental implants before any magnetic resonance imaging (MRI) or x-ray procedures. Dental implants can distort or interfere with these images. The FDA is not aware of any adverse events reported for MRI or X-ray procedures with dental implants.

Ways dental implants are rated for safety

Dental implant systems are generally made of materials that conform to international consensus standards of the International Organization for Standardization (ISO) or ASTM International. These standards contain details of what makes a material safe. Most dental implant systems are made of titanium or zirconium oxide. Other materials such as gold alloys, cobalt based alloys, titanium alloys or ceramic materials are sometimes used. The safety profiles of these materials are well known.

Dental implant systems are evaluated according to international consensus standards. Biocompatibility testing, to show that bodily contact with the device does not cause complications such as irritation or allergic reaction, is part of the evaluation that helps ensure that the materials of the dental implant system are safe and do not cause adverse effects when implanted in people.

For manufacturers to market dental implant systems in the United States, they must first show the FDA that their systems are as safe and effective as dental implant systems already on the market.

To visit https://www.unionimplants.com/about/faqs for more information on implants.

Article originally posted at https://www.fda.gov/medical-devices/dental-devices/dental-implants-what-you-should-know



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