Recommendations for implant applicants

Dental implants are medical devices surgically implanted into the jawbone to restore a person’s ability to chew or restore their appearance. They support artificial teeth such as crowns, bridges, or dentures. Dental implants are one of the newest dental implant procedures in the industry.

Problems and Reasons for Needing Implants

When a tooth is lost due to injury or disease, a person can experience complications such as rapid bone loss, slurred speech, or changes in chewing patterns that lead to discomfort. Replacing a missing tooth with a dental implant can significantly improve a 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 dental implant body is surgically placed in the jawbone in place of the tooth root. The dental implant abutment is usually attached to the implant body by an abutment fixation screw and extends through the gum into the mouth to support the attached denture.

Advice for Implant Applicants

Before choosing a dental implant, talk to your dental provider about the potential benefits and risks and whether you are a candidate for the procedure. Things to consider:

Your overall health is important in determining whether you are a good candidate for a dental implant, as the recovery time and how long the implant will remain in place.

Ask your dental provider what brand and model of dental implant system is used and keep this information for your records.

Smoking may affect the healing process and reduce the long-term success of the implant.

The healing process of the implant body may take several months or longer, during which time you will usually have a temporary abutment in place of the tooth.

After your dental implant procedure:

Carefully follow the oral hygiene instructions given to you by your dental professional. 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 is loose or painful, notify your dentist in Ottawa immediately.

Benefits and Risks of Implants

Dental implants can significantly improve the quality of life and health of the individual who needs them. However, sometimes complications can occur. Complications can occur soon after dental implant placement or much later. Some complications result in implant failure (usually defined as loosening or loss of the implant). Implant failure can result in the need for another surgical procedure to repair or replace the implant system.

Benefits of a Dental Implant System:

• Restores chewing ability
• Restores cosmetic appearance
• Helps prevent jawbone shrinkage due to bone loss
• Maintains the health of the surrounding bone and gums
• Helps hold adjacent (nearby) teeth in place
• Improves quality of life

Risks associated with dental implant systems:

• Damage to surrounding natural teeth during implant placement
• Damage to surrounding tissues during surgery, such as sinus perforation
• Damage during surgery (e.g., fracture of the surrounding jawbone)
• Inadequate function, such as a feeling that the teeth do not bite together normally
• A feeling that the tooth is loose or twisted in place due to the loosening of the abutment screw

Implant failure

• Due to systemic infection, which may be more common in patients with uncontrolled diabetes
• Due to local infection in the bone and gums supporting the implant body
• Due to delayed healing, which may be more common in patients who smoke
• Difficulty cleaning the gums around the implant, resulting in poor oral hygiene
• Untreated periodontal disease
• Postoperative numbness due to impaction or nerve damage

Always tell your healthcare provider 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 reported adverse events for MRI or X-ray procedures with dental implants.

Methods by which dental implants are evaluated for safety

Dental implant systems are typically made of materials that follow international consensus standards from the International Organization for Standardization (ISO) or ASTM International. These standards detail what constitutes a safe material. Most dental implant systems are made of titanium or zirconium oxide. Sometimes other materials are used, such as gold alloys, cobalt-based alloys, titanium alloys, or ceramic materials. The safety profiles of these materials are well-known.

Dental implant systems are evaluated based on international consensus standards. Biocompatibility testing, to demonstrate that physical contact with the device does not cause adverse effects such as irritation or allergic reactions, is part of the evaluation that helps ensure that the materials in the dental implant system are safe and will not cause adverse effects when implanted in individuals.

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

Reporting Dental Implant System Problems to the FDA

Reporting adverse events promptly can help the FDA identify and better understand the risks associated with medical products. If you have a problem with your dental implant system, including your dental implant body, dental abutment, or dental abutment screw, we recommend that you contact the clinic where you received your dental implant immediately.

To help us learn as much as possible about the side effects associated with your dental implant system, please provide a complete description of your problems, pain, or discomfort.