A Study to Assess Clinical Gingivitis and Microbiome Following the Use of Multiple Oral Hygiene Products

Inclusion criteria

• give written informed consent prior to their participation;
• be 18 to 65 years of age at the time of enrollment;
• agree not to participate in any other oral/dental product studies;
• agree to delay any elective dentistry (including a dental prophylaxis);
• agree to refrain from the use of any non-study oral care products (including floss and mouthrinse) during the course of the study;
• agree to return for the scheduled visits and follow study procedures;
• be in good general health as determined by the investigator/designee based on a review of the health history/update for participation in the study;
• have more than 10 bleeding sites at visits 1-3
• Consistency of bleeding site number at baseline may be considered;
• have a minimum of 18 natural teeth with facial and lingual scorable surfaces; and
• refrain from performing any oral hygiene or consuming anything by mouth (except a small amount of water) at least 4 hours prior to their appointment.

Exclusion criteria

• teeth that are grossly carious, fully crowned, extensively restored and have heavy dental calculus
• antibiotic, anti-inflammatory or anti-coagulant therapy within two weeks of to the baseline exam
• medical conditions that the investigator considers significant and that may compromise the evaluation of study results
• currently participating in any other clinical trial
• participated in a clinical trial for plaque/gingivitis within the previous 30 days
• pregnant or lactating
• orthodontic appliances or removable partial dentures
• soft or hard tissue tumor of the oral cavity
• advanced periodontal disease
• history of hepatitis, diabetes, or other communicable diseases
• history of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• history of significant adverse effects following the use of oral hygiene products such as toothpaste
• oral pathoses that could interfere with compliance and/or examinations or that need treatment.