Frequently Asked Questions
1. Is there any clinical trial information available?
Yes. Data from a randomized and controlled clinical trial on 45 patients is available. In general, patients were young, with an average age of 21.5 years (median 18.8, range 12.4 to 40.6). Seventeen males and 28 females were enrolled in the study with the following ethnic origins: 26 Hispanic, 14 Caucasian, 4 African American and 1 Asian. Twenty-three patients received treatment with a functioning AcceleDent appliance (treatment group) and 22 patients with a non-functioning AcceleDent appliance (sham control group). Mini mplants provided posterior anchorage and a fixed reference point for measurements during space closure. The reported adverse events were similar between the treatment and control groups and there were no reports of unintended adverse device effects. A safety review of panographic x-rays showed no indication of increased root resorption due to AcceleDent use and the number of patients with loose mini implants was equally distributed between the treatment and control groups. Note that root resorption is possible with any orthodontic case - talk to your orthodontist about this unintended treatment consequence. AcceleDent was well tolerated and did not increase the level of discomfort associated with orthodontic treatment. Most patients found AcceleDent easy-to-use, reliable and easy-to-clean. Overall satisfaction for AcceleDent was high and increased with time. Several patients did report some drooling associated with AcceleDent use; this experience typically lessened over time. During space closure, patients’ teeth moved an average 38% to 50% faster in the group treated with AcceleDent. Additionally, surveys asked patients at each visit about the most common activities engaged during appliance use and what one word they would use to describe their experience. The most common activities during use were watching television, reading, using the computer, listening to music and doing homework. The most frequently used words to describe AcceleDent were easy, effortless, good and simple.
2. How does AcceleDent work?
The appliance uses patented technology to gently pulse the teeth and surrounding structures such as the alveolar bone and the periodontal ligament (which serves to “attach” the teeth and bone).
3. Who can benefit from using AcceleDent?
The AcceleDent System is designed to increase the rate of tooth movement in patients undergoing treatment with a conventional fixed orthodontic appliance, which may reduce treatment time. The use of AcceleDent with other types of orthodontic appliances has not been studied.
4. How can I determine whether or not AcceleDent is working for me?
Your orthodontist has the ability to measure the amount of tooth movement that has taken place while using AcceleDent. You should contact your orthodontist to help you understand how much you are benefiting from AcceleDent.
5. Is AcceleDent safe?
AcceleDent has a good safety profile, as indicated by a university study in humans and several animal studies. AcceleDent is considered safe under normal conditions of use with a conventional fixed orthodontic appliance.
6. How often should I see my orthodontist?
Your orthodontist will help you determine how often you should be seen for orthodontic appointments.
7. Does AcceleDent hurt while being used?
In clinical trials, AcceleDent was well tolerated and did not increase the level of discomfort associated with orthodontic treatment.
8. How can I get further information regarding AcceleDent?
You may contact your orthodontist regarding the proper use of your appliance. You may also visit the following website: www.acceledent.com
9. What if the appliance is just turned “on” and then set down on the countertop for the required twenty minutes?
The compliance information will be transferred to the Charging Port and it will appear that the appliance was used for a full session. However, there will be no clinical benefit and so it is likely that an orthodontist will be able to determine non-compliance clinically.
10. If I absolutely have to interrupt the twenty-minute session for a few minutes, when I turn it back on, does it have memory toward the twenty minutes or does it reset?
The appliance will maintain memory toward the twenty-minute total use duration as long as the interruption does not exceed five minutes. After five minutes of being turned off, the appliance will work (pulse) for a full session of twenty minutes at its next use.
11. How do I know if I am biting into the Mouthpiece correctly and with the right amount of force?
Bite pressure on the Mouthpiece should be just firm enough to hold the appliance in place without the use of the hands. It is not necessary to bite forcefully into the Mouthpiece. Doing so will cause the Mouthpiece to wear out more quickly and may require it to be replaced.
12. If I use the appliance for more than the recommended duration, does it add incremental benefit?
No. The appliance initiates a biological change in the bone surrounding the roots of your teeth. Additional daily use greater than the prescribed twenty-minute duration has not been evaluated and thus is not recommended.
13. What is the best way to clean AcceleDent?
The Mouthpiece should be rinsed well with lukewarm water after each use. You may occasionally use a soft liquid dishwashing detergent, or a mild soap or toothpaste to gently brush the Mouthpiece. The Activator can be wiped with a damp cloth as necessary. The metal contacts of the Activator must be free of any dirt or residue and may be cleaned with a Q-Tip® as needed. It is recommended that the appliance air dry before being stored in the Travel Shell. Do not use a dishwasher as this will void the warranty and could cause damage to the product.
14. Can I use my AcceleDent in the shower?
No, the appliance is not water-resistant and should not be used in the shower.
15. Can I sanitize my AcceleDent and share it with a friend who also has braces?
AcceleDent is a prescription appliance for a single patient. Sharing the appliance and/or Mouthpiece is not recommended. The appliance has been fitted for your use and based on your orthodontic case and treatment. As with many medical devices, use by an individual without the proper issuance from an orthodontist can result in unintended consequences. In addition, use of the appliance by more than one person may result in the transmission of viral and bacterial infective agents, even if an effort has been made to sanitize it.
16. Can I try to wear AcceleDent while I am sleeping?
It is not recommended that the appliance be used while sleeping.
17. Is there some way that AcceleDent can “track” my usage?
Yes. Docking the Activator (which requires enclosing it within the Travel Shell) on the Charging Port also allows the usage history and details to be registered. The amount of usage can then be observed on the Smart Display.
18. Is there some way that AcceleDent can remind me to use it on a daily basis?
The appliance is not designed to provide reminders. It is recommended that AcceleDent be worked into some part of your daily routine in order to maximize compliance.
19. It feels powerful - is there a lower-intensity setting?
The intensity cannot be reduced. The settings for the appliance have been preset and cannot be adjusted.
20. How often does the appliance need to be recharged?
It is recommended that the appliance be placed on the Charging Port only when it needs to be recharged as indicated by the Battery Gauge on the Activator (approximately every five days). Recharging the Activator more often will ultimately reduce the battery life.
21. How long does a charge last?
Once fully charged, the appliance will hold enough charge to last for approximately five days, based on recommended usage duration.
22. What type of battery does the appliance contain?
The rechargeable battery in the appliance is a medical grade Lithium ion battery.
23. When my treatment is complete, what should I do with the appliance?
Reference the “Disposal” section of the Directions for Use manual for further details.
24. Why do I experience a tingling sensation when I use the appliance? Is this normal?
You may experience a tingling sensation, similar to a vibrating toothbrush, when using AcceleDent for the first several times. This sensation will diminish as you become more accustomed to using the appliance.
25. Is the product under warranty?
Yes, the details of the warranty can be found in the Directions for Use manual, or on our website by clicking here for Warranty Information.
26. Is there a trouble shooting guide available?
Yes, there is a trouble shooting guide available: AcceleDent™ Trouble Shooting Guide