Twice-daily 30-minute Emanate Perio PODS after deep cleaning versus no treatment

RANDOMIZED CONTROLLED CLINICAL TRIAL TO ASSESS THE SAFETY AND EFFECTIVENESS OF A PERIODONTAL HYDROGEL WOUND DRESSING (EMANATE PERIO PODS) ON WOUND HEALING POST-SCALING AND ROOT PLANING

We will test whether using a protective periodontal hydrogel (Emanate Perio PODS) for 30 minutes twice a day after deep cleaning helps healing in adults with generalized Stage III periodontitis compared with no treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 30 Years to 75 Years
• Sex: All
• Sponsor: McGuire Institute (Industry-sponsored)
• Locations: 9 sites (Fullerton, California and 8 other locations)
• Trial ID: NCT06914596 on ClinicalTrials.gov

What this trial studies

Adults with generalized Stage III periodontitis who have received scaling and root planing (SRP) are assigned to either apply Emanate Perio PODS for 30 minutes immediately after toothbrushing and interdental cleaning twice daily or to receive no additional post-SRP treatment. The dressing is intended to physically protect the healing periodontal pocket while the epithelium reestablishes itself, and use is limited to about four weeks when epithelial maturation typically occurs. Clinical outcomes such as probing pocket depth, clinical attachment level, and safety/adverse events are measured over the follow-up period to compare healing between groups. The protocol aligns PODS application with routine twice-daily oral hygiene to minimize burden and support adherence.

Who should consider this trial

Good fit: Adults aged 30–75 with generalized Stage III periodontitis who have at least 8 interproximal sites with ≥3 mm attachment loss and probing depths of 5–7 mm, at least 24 natural teeth, and who can follow twice-daily application after SRP are the intended participants.

Not a fit: Patients with shallower disease, pockets outside the 5–7 mm range, hopeless teeth with high mobility or suppuration, or those unable to comply with twice-daily application are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this device could speed or improve early wound healing after SRP, potentially reducing pocket depths and lowering infection risk.

How similar studies have performed: There is limited prior clinical data specifically on periodontal hydrogel dressings for post-SRP healing, so this approach is relatively novel though it draws on established wound-protection principles from other fields.

Eligibility criteria

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. 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:

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 or a cleaning/prophylaxis 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).
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.

Where this trial is running

Fullerton, California and 8 other locations

• Regenerative Solutions — Fullerton, California, United States (Recruiting)
• Shoreline Periodontics and Dental Implants — New London, Connecticut, United States (Recruiting)
• The Perio Studio — Boston, Massachusetts, United States (Not_yet_recruiting)
• Metro West Orthodontics & Periodontics — La Vista, Nebraska, United States (Recruiting)
• Perio Health Professionals — Houston, Texas, United States (Recruiting)
• Perio Health Professionals — Houston, Texas, United States (Recruiting)
• Periodontal Center of Excellence, PLLC — Spring, Texas, United States (Recruiting)
• Glazier Implants + Periodontics — Richmond, Virginia, United States (Recruiting)
• Seattle Periodontist and Implant Dentistry — Seattle, Washington, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Jill Fuqua

Conditions Periodontitis