Cold Plasma for Dental Restoration and Caries Prevention

The study will be a randomized controlled trial (RCT) and be approved by the institute
review board of the University of Tennessee Health Science Center. The study subjects will
be composed of young adults 18-35 years old in order to control effects of age on caries.
Also the subjects must be Caucasian or Africa American. Young adult patients will be
recruited from the UTHSC dental clinics.The baseline visit include a dental exam by one of
the investigators, standard preventive dental care (e.g cleaning, application of fluoride
varnish), anthropometric measurements, oral health interview survey. 100 patients who meet
all inclusion and exclusion criteria will be recruited after they sign an informed consent
form. These patients will be randomly assigned to 1 of 2 study groups. Randomization
assignment will be stratified by age and number of teeth with caries. Two study groups will
be: 1.) plasma treatment group and 2) standard treatment group. For patients in standard
treatment group, they will receive composite resin restoration for all decayed teeth and
standard preventive treatment (cleaning and fluoride varnish application) at baseline. For
patients in plasma treatment group, they will receive plasma treatment after cavity
preparation, composite resin restoration, standard preventive treatment followed by plasma
treatment for non-carious teeth. Standard preventive treatment and plasma treatment will be
repeated on semi-annual (6-month) recall visits. All composite restorations will be placed
according to the manufacturer's instruction. Only one composite commercially available will
be used during the study.

Inclusion Criteria:

- subject must be Caucasian or Africa American, 18-35 years old, have written,
completed, informed consent forms;

- be generally healthy;

- be able to participate in the study;

- have no diagnosed periodontitis and pericoronitis;

- have no active mucosal diseases such as aphthous ulcers and herpetic stomatitis.

They must also agree to follow study instructions.

The patients must meet the following specific entry criteria:

- 1-5 untreated caries and at least one class II caries.

Exclusion Criteria:

- each subject must have no diagnosed diabetes mellitus or any other endocrine
diseases;

- no diagnosed cardiovascular diseases;

- no diagnosed immune-compromised diseases, such as HIV and AIDS;

- no other serious systemic diseases, such as cancer;

- no antibiotic therapy in the past 6 months;

- no use of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 3 months; and

- no reported use of illicit drugs.