A Clinical Trial Comparing Overnight and 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP

Launched by MCGUIRE INSTITUTE · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to explore how well a special hydrogel dressing, called Emanate Perio PODS, helps heal the gums of people with a serious gum disease known as generalized stage III periodontitis. The trial will compare two different ways of using this dressing: applying it overnight versus twice a day for 30 minutes. Researchers want to see if using this dressing after a dental cleaning leads to better healing compared to not using any treatment at all.

To participate, individuals must be between 22 and 75 years old and have specific gum health issues, including having at least eight teeth with certain measurements of gum attachment and pocket depth. Participants will need to be able to care for their oral hygiene independently and should refrain from using certain types of mouthwashes and dental devices during the study. If eligible, participants can expect regular check-ins and specific instructions on how to use the dressing. This trial is important as it may provide new insights into effective treatments for improving gum health in patients with periodontitis.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
• • 2. Subjects 22 to 75 years of age.
• • 3. 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
• • 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:
• • 1. Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis six 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).
• • 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.