[Note:  Dr. Rothstein is not a provider of the DDS Appliance (System)]

Patient Consent

DDS System^Tm

A Product of Scientific Intake Ltd.

Fifteen Piedmont Center, Suite 500

Atlanta GA 30305

Informed consent for DDS System^Tm  Behavior Modification Appliance

The purpose of Informed Consent is to provide you with the knowledge you need to make an informed decision whether or not you need to have made and use the DDS System which includes the DDS System Behavior Modification Appliance (the “DDS Appliance”).

What is the DDS System?

The DDS System includes an oral appliance similar to an orthodontic retainer. When fitted to your mouth and worn properly while eating, it will help you learn to consume food at a slower rate by decreasing the size of your oral cavity and the amount of food per bite you can hold in your mouth.

How do I use it?

The DDS appliance is to be worn only when you eat. Before you eat you should insert the DDS Appliance in the roof of your mouth.  It is held in place through a combination of ball clasps and suction.  Following your meal or snack, you should remove the DDS Appliance by gently grabbing the ball clasps and pulling downward. Once removed, the DDS Appliance should be thoroughly washed to remove all remaining food particles and stored on a clean container. You dentist can show you how to use the DDS Appliance properly.

What will happen today?

Today, your dentist will help you decide the DDS System is right for you. If after considering all the information and discussing it with  your dentist, you decide that the DDS System is right for you, your dentist will take in impression of your mouth, as the DDS Appliance must be fabricated to your mouth..  The dental model ensures that the DDS Appliance will fit exactly in your mouth. Certain trained Staff in your dentist’s office may assist in creating impressions for the DDS System.  In a few weeks, you will be able to return to your dentist’s office and receive your custom-made DDS Appliance and DDS System materials.

What the DDS System does for you?

-         When used properly, the DDS System can help you eat your food slower. After eating for a period of time that varies from person to person, you trigger the satiety response ( the feeling of being satisfied). It is likely that you will consume less food and eat slower.

-         Having food in your mouth longer may give you a longer period of taste sensation and reduce the need to consume more food to achieve the same level of taste satisfaction

-         More thorough chewing of smaller bites allows more thoroughly chewed food to enter your stomach.

Using the DDS System Safely

Various individual have worn the DDS Appliance during its development.  No harmful effects have been reported. However, before agreeing to be fitted with a DDS Appliance, you should be aware of how to use it safely and properly. Appliances held in place by suction and ball clasps have been available for more than fifty years and are larger than the throat. Therefore, it is not likely you will be able to swallow it. As with any appliance in the mouth during eating, it is important to make sure it is fitted properly and is firmly in place prior to food consumption. You should not wear the DDS Appliance if you suffer from anorexia or bulimia or you have a body mass index of 25 or below. [http://nhlbisupport.com/bmi/bmicalc.htm to calculate your Body Mass Index]. Your dentist can help you assess your body mass index.  Use of the DDS System may result in certain risks, particularly if it is not use as directed, For example:

-Introduction of bacteria: You should wash the DDS Appliance after using it to ensure that you do not introduce any bacteria into your mouth during subsequent uses. Bacteria may cause infections that can lead to injury or death.

-Choking hazard: You should not bite the DDS Appliance as you may separate the a piece of the appliance and ingest this piece.  Individual pieces present a choking hazard which may lead to choking or death.  You may also damage your teeth by biting the DDS Appliance.

- Sensing foreign objects: The DDS Appliance covers the roof of your mouth. Therefore, if you happen to intake a foreign object (such as a bone) into your mouth while eating, you may not be able to sense the foreign object in your mouth and consequently swallow the foreign object. Therefore you should chew your food very carefully while using the DDS Appliance.

-Hot Liquid Hazard:  The DDS Appliance covers the roof of your mouth, which serves as a temperature sensor. Therefore, if you drink overly heated liquid, you may not be able to sense the temperature before swallowing. Therefore, you should test the temperature of hot liquids before drinking, while using the DDS Appliance.

- Improper Use: You should only use the DDS System as directed by your dentist and in accordance with the guide.  Failure to use the DDS System properly can lead to unknown risks. You must read the materials included with your DDS System in detail before using the DDS Appliance.

- Unknown risks:  No long-term of the effect of decreasing the size of the oral cavity with an appliance such as the have been conducted. Therefore, there may be unknown risks with use of the DDS System.

Use of the DDS System is completely voluntary.

Modifying your behavior:

The DDS Appliance is a behavior modification appliance.  There are other behavior modification alternatives available to you to reduce your food intake, including the following:

-         Educational means – you can learn appropriate consumption methods through various educational methods

-         Counseling

-         Personal willpower

Your records

Your dentist will maintain your DDS System records.  If your dentist is not your regular dentist, you agree your DDS System dentist may send a copy of these records to your regular dentist.

If you register with Scientific Intake Limited at www.ddssystem.com

 Your personal information will be maintained in accordance with Scientific Intake’s privacy policy which can be read on Scientific Intake’s private policy which can be read on Scientific Intakes website.

ACKNOWLEDGMENT OF CONSENT

By purchasing the DDS System, I represent and warrant that (i) I will read the instructional materials provided with the DDS System in detail and will comply with the requirements therein, (ii) I have reviewed the body mass index chart with my dentist and I have a body mass index above 25.0, and (iii) I do not suffer from either anorexia or bulimia.

I have read the above information. This information has been explained to me and I have had the opportunity to ask questions. Before I use the DDS Appliance, I will read and comply with the instructional materials provided with the DDS System. I understand the directed use of the DDS System and accept any explained or unexplained risks that may be present with the use of the DDS System.

I hereby acknowledge that I am voluntarily using the DDS System.  I am not relying on my dentist for any medical advice. I hereby release for liability and hold harmless the dentist from any injury suffered by me as a result of the procedure to fit me for the DDS System or my use thereof.  I authorize the dentist to inform my personal physician that I am utilizing the DDS System program.  I am 18 year of age or older.

Patient Name: _____________  Date: ________  Signature: _________

Witness Name:  ____________ Date: ________  Signature: _________

Dentist Name:  _____________Date: ________   Signature: _________