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

Not Applicable

Not yet recruiting

• Conditions: Periodontitis (Stage 3)

• Registration Number: NCT06914596
• Lead Sponsor: McGuire Institute

Brief Summary

The goal of this clinical trial is to compare safety and to see if individuals with generalized stage III periodontitis that are given a periodontal hydrogel dressing on a wound healing after plaque and tartar have been removed from teeth have greater healing than individuals who are given no treatment after.

Detailed Description

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 and overnight 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.

Study Timeline

• Study First Submitted: 2024-12-30
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-31
• Study First Posted: 2025-04-06
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

McClain and Schallhorn Periodontics and Implant Dentistry; 🇺🇸 Aurora, Colorado, United States

Shoreline Periodontics and Dental Implants; 🇺🇸 New London, Connecticut, United States

Metro West Orthodontics & Periodontics; 🇺🇸 La Vista, Nebraska, United States

Perio Health Professionals; 🇺🇸 Houston, Texas, United States

Gulf Coast Periodontics; 🇺🇸 Victoria, Texas, United States

Glazier Implants + Periodontics; 🇺🇸 Richmond, Virginia, United States

Richardson, Overstreet, & White Ltd.; 🇺🇸 Richmond, Virginia, United States