Revitalization of Teeth With Necrotic Pulps and Open Apexes Using Platelet-Rich Plasma

Procedures Participants in this study must be in overall good health and not allergic to the
materials used during this study treatment. If you agree to participate in this study, you
will receive a screening visit to determine whether you will qualify for the study. At that
time, your medical history will be reviewed, your blood pressure and pulse will be taken and
you will be asked to fill out detailed medical and dental histories. In addition, you will
receive an examination of your teeth and gums.

In the first appointment, after anesthetizing you with a local anesthetic similar to
Novocain and application of a rubber dam to isolate your tooth, an opening will be made into
the root canal(s). The canal(s) will be cleaned and medicated with antibiotics to get rid of
the infection and sealed with a temporary filling material. Except for the use of
antibiotics the rest of the procedures done in this appointment are similar to what the
investigators do for the patients for need root canal treatment.

In the second appointment, after providing anesthesia with Novocain and application of
rubber dam again, the temporary filling will be removed and the antibiotic will be removed
using sterile water. The canal will be then dried. During this appointment, 20 ml of whole
blood will be taken from your arm vein and will be used to prepare concentrated cells for
injection into the prepared canal and sealed again with a temporary filling material. This
part is different than what the investigators normally do for patients who need root canal
treatment. For those patients the investigators fill the canals and seal the opening into
the root canals with a permanent filling material.

You will return three to seven days later to the endodontic clinic and at that time, after
rubber dam application, the temporary filling material will be removed and the tooth will be
double sealed with permanent filling materials. This is an extra step that the
investigators normally do not take for patients who need root canal treatment. A dental
assistant or a dentist will call you to make an appointment at 3, 6, 12, 18, and 24 months
following completion of your root canal treatment to check the vitality of the tooth using
an ice stick and closure of the root end. Checking the process of healing in your tooth is
similar to what the investigators routinely do for our patients who require root canal
treatment.

Risks The study will require drawing blood from your arm. Veins and arteries vary in size
from one person to another and from one side of the body to the other. Obtaining a blood
sample from some people may be more difficult than from others. Other risks associated with
having blood drawn are slight but may include bleeding, fainting or feeling light-headed,
hematoma (blood accumulating under the skin), and infection (a slight risk any time the skin
is broken). In rare instances, it may cause severe pain of infection. Depending upon the
complications, your dentist may decide to remove the PRP completely out of the root canal
and the use other procedures to treat your tooth. Should root canal failure occur, further
dental treatment will be rendered at no charge to you.

Benefits Whether or not you will benefit from this study is not yet known. However, there is
a possibility of saving the tooth with this procedure. Your participation will help
dentists learn about the importance of regeneration of nerves in teeth with infection and
open root ends, and may help save your tooth.

Participants' Rights Your participation in this study is voluntary. Your decision whether or
not to participate or terminate at any time will not affect your present or future treatment
here at the Dental School. You may withdraw from the study at any time that you want to.

Alternative Treatments You can choose not to participate in this study and have your tooth
treated with the standard root canal procedures or have it extracted. Refusal to participate
in this study will involve no penalties or loss of usual benefits to which you are entitled.

Confidentiality The medical information collected in this study will be available to the
investigators, the U.S. Food and Drug Administration, and the Institutional Review Board of
Loma Linda University. The results may be published but your name will not be used in
publications. However, submission of the information will be accomplished with strict
adherence to the professional standards of confidentiality. See attached PHI Authorization
for more information about your privacy. Your name and address will be kept on record at the
investigator's office in case you need to be contacted in the future about this study.

Inclusion Criteria:

- People with necrotic pulp and open apex.

Exclusion Criteria:

- People with vital pulp and closed apexes