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

Periodontitis can be considered a chronic wound, in which the barrier has been compromised allowing pathogenic bacteria to infiltrate the subgingival space.

In this study, the Emanate Perio PODS dressing is applied for 30 minutes immediately after toothbrushing and interdental cleaning to physically protect the healing periodontal pocket from pathogenic bacteria while the epithelium reestablishes itself; which usually takes between 15-30 minutes. By week four post SRP, the epithelium matures enough to withstand the mechanical forces and therefore the treatment can stop. It is hypothesized that during the initial phases of healing, i.e., day 1 to day 30, and in the absence of mechanical forces, the epithelium can protect the subgingival pocket, and Emanate Perio PODS dressing is only applied after toothbrushing and interdental cleaning when tissue is exposed to disruptive mechanical forces. The limited use of the device minimizes the burden of use on patients and aligns with recommended twice daily toothbrushing which can improve treatment adherence and compliance.

• Emanate Perio PODS (Device): Emanate Perio PODS used 2x/day for 30 minutes use

Primary outcomes

• Effectiveness on periodontal wound healing compared to control as evidenced by the presence/absence of gingival bleeding [60 Days post non-surgical therapy]: Change in Bleeding on Marginal Probing (BOMP) over time at 60 Days post non-surgical therapy

Secondary outcomes

• Effectiveness on periodontal wound healing compared to control [60 Days post non-surgical therapy]: As evidenced by change in Modified Gingival Index (MGI)
• Effectiveness on periodontal wound healing compared to control [60 Days post non-surgical therapy]: As evidenced by change change in Pocket Depth (PD) over time in sites with baseline pockets >/=4mm

Other outcomes

• Effectiveness on periodontal wound healing compared to the historical treatment effect of non-surgical therapy [60 Days post non-surgical therapy]: Change in Pocket Depth (PD) over time in sites with baseline pockets >/=4mm at 60 days post non-surgical therapy
• Feasibility of usage of the Emanate Perio PODS twice a day group [Day 15]: Feasibility will be characterized by compliance at Day 15 post non-surgical therapy
• Feasibility of usage of the Emanate Perio PODS twice a day group [Pre-treatment, Day 15, Day 30]: Feasibility will be characterized by Dropout rate pre-treatment and at day 15 and Day 30
• Feasibility of usage of the Emanate Perio PODS twice a day group [Pre-treatment, Day 15]: Feasibility will be characterized by mouthpiece fit and comfort as measured using the VAS at Day 0 and at Day 15 post non-surgical therapy

Sex: All, ages: 30 Years to 75 Years

Inclusion Criteria:

Subjects must meet all the following criteria to be entered into the study:

1. Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
2. Subjects 30 to 75 years of age.
3. 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. A maximum of 3 teeth and not more than 6 sites with a PD of 9 mm is acceptable if the tooth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater.
4. Subjects have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
5. 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.
6. 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.).
7. Subjects agree to refrain from use of electric flossers or irrigation devices for the duration of the study.
8. Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
9. 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:

1. Periodontal surgery, implant placement or SRP within 12 months prior to screening; surgical and simple tooth extractions or a cleaning/prophylaxis within three months prior to screening.
2. Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
3. Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
4. Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
5. Subjects with soft or hard tissue tumor(s) of oral cavity.
6. 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.
7. Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer).
8. Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
9. Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia) including but not limited to:

   1. Anticonvulsants: Phenytoin, Phenobarbital, Sodium Valproate (Valproic Acid), Lamotrigine, Vigabatrin, Ethosuximide, Topiramate, Primidone.
   2. Calcium Channel Blockers (CCBs): Nifedipine, Amlodipine, Diltiazem, Verapamil, Felodipine
   3. Immunosuppressants: Cyclosporine, Tacrolimus, Sirolimus (Rapamycin), Everolimus.
   4. Oral Contraceptives: Hormonal therapies containing high levels of estrogen or progesterone.
   5. Certain Psychotropic Medications: Pimozide (antipsychotic); Sertraline, Paroxetine (antidepressants).
10. Regular, prolonged use of oral antimicrobial rinses 30 days prior to screening or continued anticipated use through their projected study duration.
11. Use of systemic antibiotics 30 days prior to screening or anticipated during the trial period.
12. Subjects taking corticosteroids on a regular basis one week prior to baseline examination and throughout the duration of the study, including oral inhalers.
13. 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.
14. Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis.
15. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental) within 30 days of Screening.
16. Subjects that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol or ethylene vinyl acetate.
17. 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.

• Jarret Fass, Study director, Emanate Biomedical