Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care

Inclusion criteria

• Understands and is willing to sign an Informed Consent, approved by the local Ethics Committee.
• Female or male, ages 18-95 years old (inclusive)
• Systemically healthy.
• Presence of at least three evaluable teeth in each quadrant.
• Moderate gingival inflammation, with at least a 10% of bleeding on probing (BOP) will be required together with moderate level of plaque.
• No Grade 3 Tooth Mobility
• Treated stage II or III periodontitis patients, whose active treatment has finalized more than 6 months before. Stage II - Interdental clinical attachment level (CAL) at the site of greatest loss equal to 3 to 4 millimeters with maximum probing depth of less than or equal to 5 millimeters. Stage III - Interdental CAL at the site of greatest loss greater than equal to 5 millimeters, probing depth (PD) greater than or equal to 6 millimeters, and radiographic vertical bone loss
• Enrolled in a periodontal maintenance treatment program
• No orthodontic banding (no permanent retainers, no orthodontic appliances (i.e., no removable plastic/metal retainer) or removable prosthesis (no removable partial and/or full denture).
• Subjects willing to participate and comply with the requirements of the study.
• Subjects that brush their teeth regularly (once or twice daily).
• Able to travel to and attend 4 research study visits over the span of the next 6 months.
• Able to independently provide consent for oneself.
• Fluent in reading, comprehending, and speaking English without assistance from a translator.
• If a patient is using prevident, they must be willing to stop using it.

Exclusion criteria

• Untreated or uncontrolled periodontitis or advanced (advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
• Antibiotics intake within the previous month.
• Pregnant women and/or breastfeeding women
• Any adverse medical history (controlled and uncontrolled diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.
• Conditions which require antibiotic prophylaxis (infectious endocarditis, cardiac valve prosthesis…).
• Not willing to comply with the study protocol recommendation and visit schedule.
• Current smokers or those using tobacco or vaping products.
• Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care
• Currently participating in another clinical research study now and/or within the past month.
• Has a history of allergies to oral care or personal care consumer products or their ingredients
• Has an existing medical condition that prohibits eating or drinking for periods up to 4 hours.
• Any ongoing medical condition that makes a subject unsuitable for enrollment-or any new diagnosis that arises during the study that makes the subject unsuitable to continue-may lead to exclusion, as determined by the Principal Investigator on a case by case basis. Conditions that may result in exclusion include, but are not limited to:

• Recent myocardial infarction
• Recent cerebrovascular accident
• Recent placement of a cardiac valvular prosthesis
• Severe liver dysfunction
• Known or suspected current malignancy
• New antibiotic use
• Note: The Principal Investigator will review all available information about the subject and make decisions regarding both enrollment and/or continued participation.