Lower Cholesterol Levels Associated with Use of Oral Rinse in Healthy Gingivitis Patients
C Gauntt, K McCloskey, P Siegel and G Siegel • Biomedical Development Corporation, San Antonio, TX
ABSTRACT
BACKGROUND
A novel iodine-based oral rinse is being developed as a once-daily treatment for gingivitis. The oral rinse has demonstrated broad-spectrum antimicrobial, antifungal and antiviral activity in vitro, and safety in animal and human clinical trials. Ongoing clinical studies continue to assess its safety, efficacy and potential impact on biomarkers of inflammation.
OBJECTIVE
The purpose of this study was to evaluate a novel iodine-based oral rinse for safety and for use in reducing gingivitis and biological markers of inflammation in otherwise healthy human subjects.
METHODS
All subjects received dental prophylaxis at the beginning of the study. Study participants were randomized to receive either a placebo rinse or a once-daily, 30 second iodine-based oral rinse. Subjects were evaluated four times over a three month period and dental assessment indices for gingivitis, plaque, and bleeding scores were collected. Blood tests were performed to assess safety and to determine the effects of the oral rinse on relative levels of biological markers of inflammation and low-density lipoprotein cholesterol (LDL-C). Statistical analysis was performed using the Student's t-test and the nonparametric Mann-Whitney U-test.
BACKGROUND/PREVIOUS RESULTS
Chemistry Liberates I2
Removes and kills bio lm
Inactivates endotoxin (LPS)
E ective against gingivitis and plaque
Antimicrobial
No known microbial resistance
Non-sensitizing/Non-irritating/Non-staining
Refreshing taste
In Vitro Activity – Oral Pathogens
Actinomyces naeslundii
Actinomyces
actinomycetemcomitans
Lactobacillus paracasei
Porphyromonas gingivalis
Porphyromonas intermedia
Streptococcus mutans
Streptococcus oralis
Treponema denticola
Safety / Toxicology Background
RESULTS
No treatment-related adverse events were observed. Results showed that after three months of treatment, LDL-C in the iodine-based oral rinse treatment group was significantly (p<.05) lower compared to the Placebo group. CONCLUSIONS
The novel iodine-based oral rinse was shown to be safe in the study. The use of this iodine-based oral rinse may be associated with lower LDL-C. Additional studies are needed to further define the efficacy of the once-daily iodine rinse and evaluate its effect on biological markers of inflammation.
FUTURE DIRECTION
A new 6-month placebo controlled trial (n= 76) is underway at the Center for Oral Health Research at The University of Kentucky. Study endpoints include safety, efficacy against gingivitis, and impact on biomarkers of inflammation including: a full lipid panel, endotoxin, interleukin-1 beta, interleukin-6, C-reactive protein, acute phase proteins and cardiovascular disease analytes, prostaglandin E2 and isoprostane.
Safety / Toxicology Background
Safety
No irritation/alterations in taste perception
No treatment related adverse events
No signi cant di erences in thyroid
function tests
Cholesterol – LDL-C
No signi cant di erences in LDL-C
between placebo and treatment group
at baseline
LDL-C signi cantly (p<0.05) lower in
treatment group vs. placebo at day 90
ACKNOWLEDGEMENTS
The project described was supported by Grant Number 5R44HL101821 from the National Heart, Lung, and Blood Institute. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Heart, Lung, and Blood Institute. This technology was supported in part by an award from the Kentucky Cabinet for Economic Development, Office of Commercialization and Innovation, under the Grant Agreement KSTC-184-512-12-145 with the Kentucky Science and Technology Corporation
Presented at: American Academy of Oral Medicine 2013 Annual Meeting. San Antonio, TX, USA. April 23-27, 2013. • Contact: psiegel@biodevcorp.com