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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary: 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.
Sponsor: Noveome Biotherapeutics, formerly Stemnion

Current Primary Outcome: Incidence of adverse/serious adverse events [ Time Frame: End of two weeks of treatment and at two weeks follow-up visit ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Probing pocket depth [ Time Frame: Bseline and after two weeks of treatment ]
    Depth will be measured at six sites per tooth
  • Modified gingival index [ Time Frame: Baseline and after two weeks of treatment ]
    Gingival index will be measured at six sites per tooth
  • Bleeding on probing [ Time Frame: Baseline and after two weeks of treatment ]
    Bleeding will be measured at six sites per tooth
  • Plaque index [ Time Frame: Baseline and after two weeks of treatment ]
    Only the gingival third of the tooth will be evaluated
  • Microbial analysis [ Time Frame: Baseline and after two weeks of treatment ]
    6 teeth will be sampled
  • Cytokine analysis [ Time Frame: Baseline and after two weeks of therapy ]
    Inflammatory cytokines will be sampled in crevicular fluid


Original Secondary Outcome: Same as current

Information By: Noveome Biotherapeutics, formerly Stemnion

Dates:
Date Received: February 21, 2014
Date Started: March 2014
Date Completion:
Last Updated: November 28, 2016
Last Verified: November 2016