Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)

This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two
doses of ACCS will be used. It will be given topically intra-orally daily Monday through
Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by
random chance. If there are no safety issues, cohort two will include a higher dose of ACCS
randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing
will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative
microbial analysis will be performed for common oral bacteria. There will also be an
analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the
study. Comparisons of adverse events and outcomes will be made between the subjects
receiving low dose ACCS, high dose ACCS, and saline.

Inclusion Criteria:

- good general health

- ages 18-70 years

- minimum of 20 natural teeth

- modified gingival index score of 2.0 or greater and >40 percent bleeding sites at
initial presentation.

Exclusion Criteria:

- presence of orthodontic appliance

- soft or hard tissue tumor of the oral cavity

- carious lesion requiring immediate treatment

- participation in another clinical trial within 30 days

- pregnant or breast-feeding women

- women of child-bearing potential refusing to use an acceptable method of birth
control

- antibiotic therapy within the last 30 days

- chronic use (> 3 times/week) of non-steroidal anti-inflammatory medications (NSAID).
Any use of steroids. Low dose (<325 mg) aspirin is allowed.

- immune-compromised subjects

- subjects with liver or kidney dysfunction on blood tests as evidenced by a value
equal to or greater than 2X the upper limit of normal.

- any medical history or any concomitant medication that might affect the assessment of
the study treatment or periodontal tissues such as diabetes rheumatoid arthritis,
Crohn's disease, use of nifedipine, phenytoin (Dilantin), anticoagulant medications
(e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.