The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
Saline will be applied to the gingival margin daily 5 days per week for 2 weeks
0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
Forsyth Institute
Boston, Massachusetts, United States
Incidence of adverse/serious adverse events
Time frame: End of two weeks of treatment and at two weeks follow-up visit
Probing pocket depth
Depth will be measured at six sites per tooth
Time frame: Bseline and after two weeks of treatment
Modified gingival index
Gingival index will be measured at six sites per tooth
Time frame: Baseline and after two weeks of treatment
Bleeding on probing
Bleeding will be measured at six sites per tooth
Time frame: Baseline and after two weeks of treatment
Plaque index
Only the gingival third of the tooth will be evaluated
Time frame: Baseline and after two weeks of treatment
Microbial analysis
6 teeth will be sampled
Time frame: Baseline and after two weeks of treatment
Cytokine analysis
Inflammatory cytokines will be sampled in crevicular fluid
Time frame: Baseline and after two weeks of therapy
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