Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone

Inclusion criteria

• Provision of signed, written informed consent prior to participation in any study-related procedures.
• Good general health as evidenced by medical history.
• At least 18 years of age at time of informed consent signature.
• Minimum of 18 teeth, excluding third molars.
• Generalized Stage II-III periodontitis with at least 8 teeth having interproximal clinical attachment level of ≥3 mm and a probing pocket depth of ≥4 mm and ≤7mm, distributed between mandible and 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
• Having ≥40 percent of sites with bleeding upon probing as a sign of inflammation
• Willing to use prescribed oral hygiene procedures and products
• Willingness to maintain their routine dental care
• Willing to abstain from chewing gums, mouth rinses and whitening products for the study duration.
• Ability and willingness to attend all study visits and comply with all study visits and all study procedures and requirements.
• For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, or vasectomy in partner).

Exclusion criteria

• Presence of orthodontic appliances (anterior fixed retainers are allowed as long as the qualifying teeth are not involved).
• A soft or hard tissue tumor of the oral cavity.
• Patients with heavy subgingival calculus.
• Any dental condition that requires immediate treatment, such as carious lesions.
• Dental implants will be excluded from study, but the patients will not be excluded if they are otherwise eligible
• Periodontal treatment including SRP within the prior 6 months of enrollment.
• Participation in any other clinical study within 30 days of screening or during the study.
• Pregnancy or lactation.
• Patients that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol, or ethylene vinyl acetate
• Antibiotic therapy within the last month (30 days)
• Current smoking (cigarette, cigar, e-cigarette, or marijuana) within 1 year of enrollment
• Patients that have a history of testing positive for SARS-CoV-2 per patient's report (within last 10 days) or currently having lingering/long-term COVID symptoms.
• Chronic use (≥3 times/week) of anti-inflammatory medications (e.g., non-steroidal anti inflammatory drugs, steroids). Low-dose aspirin, 81-162 mg is allowed.
• Immunocompromised subjects (i.e., subjects with AIDS, pulmonary fibrosis, undergoing chemotherapy or radiation treatment etc.).
• Diabetes Mellitus defined as a HbA1c > 6.5 per laboratory test results
• Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, and total bilirubin) levels equal to > 1.5 times the upper limit of normal
• Serum creatinine levels equal to > 2 times the upper limit of normal
• Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as nifedipine, phenytoin (Dilantin), or anticoagulant medications (e.g., warfarin [Coumadin] etc.).
• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study