Three Month Clinical Efficacy of an Ethyl Lauroyl Arginate HCL (LAE) Mouth Rinse: Effect on Gingivitis

At screening/baseline, subjects will present to the clinical site having refrained from oral hygiene for at least 8 hours, but no more than 18 hours, and from eating or smoking for at least 4 hours for baseline examinations. Baseline examinations will include Macpherson modification of the Lobene Stain Index (Extrinsic Stain), Volpe-Manhold Index (Calculus), and oral hard and soft tissue exam, Modified Gingival Index (MGI), Bleeding Index (BI) and Plaque Index (PI). After the baseline oral examinations, subjects who qualify will receive a whole-mouth supragingival dental prophylaxis and random assignment to one of three treatment groups. Subjects randomized to the control group will brush twice daily with a marketed fluoride toothpaste. Subjects randomized to the experimental group will brush twice daily with a marketed fluoride toothpaste and use an experimental mouth rinse. The last randomized group will brush twice daily with a marketed fluoride toothpaste and rinse with a marketed mouth rinse twice daily. The first product use will be conducted under supervision of study personnel. All other brushing and rinsing will be unsupervised and the subjects will be required to maintain a diary card to document twice-daily product use, with brushing and rinsing times. Diaries along with product accountability will be used to check for subject compliance. Subjects will return to the clinical site after one week (Day 7±1 day), two weeks (Day 14±2 days), four weeks (Day 28±3 days) and three months (Day 91±5 days). Oral hard and soft tissue safety, MGI, BI, and PI will be assessed at all visits. Extrinsic Stain and Calculus will be assessed at baseline, four weeks and three months by a different examiner. At the end of the study, subjects will return all used and unused product to the clinical site.