A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.

Inclusion criteria

• Subjects must meet all the following criteria to be entered into the study:
• Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
• Subjects 30 to 75 years of age.
• Generalized Stage III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥5 mm and ≤7mm, distributed between the mandible and the maxilla, with at least 2 qualifying interproximal sites in each arch. Localized and not more than 6 sites with a PD of 8 mm is acceptable as long as the tooth with 8 mm pocket depth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater.5-7
• Subjects have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
• All supragingival accretions can be removed from below the height of contour of the tooth crown to allow for a comprehensive periodontal evaluation and accurate intraoral digital scan of both arches at screening.
• Subjects agree to refrain from use of oral rinses or dentifrice with known antibacterial properties (e.g., Peridex®, Listerine®, Colgate Total®, Crest Pro-Health®, etc.).
• Subjects agree to refrain from use of electric flossers or irrigation devices for the duration of the study.
• Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
• Subjects are able and willing to follow study procedures and instructions.

Exclusion criteria

• Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
• Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis three months prior to screening.
• Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
• Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
• Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
• Subjects with soft or hard tissue tumor(s) of oral cavity.
• Use of any smoked substances such as tobacco / cannabis including cigarettes, vape, cigars, or use of smokeless tobacco 30 days prior to screening and throughout the study.
• Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer).
• Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
• Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia).
• Regular, prolonged use of oral antimicrobial rinses 30 days prior to screening or continued anticipated use through their projected study duration.
• Use of systemic antibiotics 30 days prior to screening or anticipated during the trial period.
• Subjects taking corticosteroids on a regular basis one week prior to baseline examination and throughout the duration of the study, including oral inhalers.
• Subjects taking non-steroidal anti-inflammatory (NSAIDS) or other pain medication on a daily basis for more than 3 consecutive days beginning one week prior to the baseline examination and throughout the duration of the study. Subjects are allowed to take 81 mg/day aspirin and may use oral pain medication if needed in the first 48- hours post-SRP period.
• Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis.
• Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental) within 30 days of Screening.
• Subjects that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol or ethylene vinyl acetate.
• Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.