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

Gingivitis Clinical Trial

Official title:
Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02071199
Study type Interventional
Source Noveome Biotherapeutics, formerly Stemnion
Contact
Status Completed
Phase Phase 1
Start date March 2014
Completion date December 2015
View Details
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