Clinical Evaluation of the S. Mutans STAMP, C16G2, in the Oral Cavity
Objectives: A Phase 2 clinical trial was conducted to determine the most effective formulation and mode of application of the Specifically Targeted Antimicrobial Peptide (STAMP) C16G2 that results in a reduction of Streptococcus mutans in the oral cavity. Methods: The multi-armed, double-blinded, placebo-controlled study compared a mouth rinse formula and gel formulations which were applied by manual toothbrush, electric toothbrush and custom dental trays. Prior to treatment all subjects were given an oral exam and dental prophylaxis. Microbiology of the oral cavity was assessed using saliva and occlusal biofilm samples. Samples were plated on non-selective media to assess total bacteria and selective mitis-salivarius bacitracin agar to assess Streptococcus mutans. Samples were taken prior to treatment, during the first day of treatment, 24 hours after the first treatment, and at days 1 and 7 post treatment. Results: Total bacteria decreased initially in each arm and returned to pre-treatment levels by 24 hours. This decrease in total bacteria effect was determined to be largely due to the effect of dental prophylaxis prior to treatment. After one week of treatment with C16G2 gel in a dental tray twice daily for 30 minutes all subjects who were treated per protocol had a 10-fold reduction of S. mutans compared to baseline. The reduction in S. mutans persisted through the end of the study for a majority of the subjects indicating that a durable treatment effect was achieved. Conclusions: The study showed clear superiority of the C16G2 gel when delivered via custom dental trays which will serve as the mode of application in future clinical trials.
IADR/AADR/CADR General Session
2015 IADR/AADR/CADR General Session (Boston, Massachusetts) Boston, Massachusetts
2015 1103 Clinical and Translational Science Network
Brassard, Laura
( C3 Jian
, Los Angeles
, California
, United States
)
Lee, Kenneth
( C3 Jian
, Los Angeles
, California
, United States
)
Navalta, Laura
( C3 Jian
, Los Angeles
, California
, United States
)
Rogy, Siegfried
( C3 Jian
, Los Angeles
, California
, United States
)
Eckert, Randal
( C3 Jian
, Los Angeles
, California
, United States
)
Kyme, Pierre
( C3 Jian
, Los Angeles
, California
, United States
)
Varnum, Brian
( C3 Jian
, Los Angeles
, California
, United States
)
Kaplan, Chris
( C3 Jian
, Los Angeles
, California
, United States
)
C3 Jian, Inc. is involved in the development of C16G2 for the treatment and prevention of dental caries in adults and pediatrics.
Poster Session
Clinical and Translational Research Studies
Thursday,
03/12/2015
, 02:00PM - 03:15PM