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

April 22, 2026 updated by: McGuire Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Regenerative Solutions
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mylea Hunter, DDS, MS, RDH
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Recruiting
        • Shoreline Periodontics and Dental Implants
        • Contact:
        • Contact:
        • Principal Investigator:
          • Geogory Toback, DMD,MS
    • Massachusetts
      • Boston, Massachusetts, United States, 02108
    • Nebraska
      • La Vista, Nebraska, United States, 68128
        • Recruiting
        • Metro West Orthodontics & Periodontics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takanari Miyamoto, DDS,MBA
    • Texas
      • Houston, Texas, United States, 77063
        • Recruiting
        • Perio Health Professionals
        • Contact:
        • Contact:
        • Principal Investigator:
          • E. Todd Scheyer, DDS, MS
      • Spring, Texas, United States, 77380
        • Recruiting
        • Periodontal Center of Excellence, PLLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ali Sajadi, DDS, MDS, FACD, FICD
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Glazier Implants + Periodontics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Glazier, DDS,MSD
    • Washington
      • Seattle, Washington, United States, 98101
        • Not yet recruiting
        • Seattle Periodontist and Implant Dentistry
        • Contact:
        • Principal Investigator:
          • Ashley Hoders, DMD, MSD, FACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A - 2x/day PODS
Emanate Perio PODS used 2x/day for 30 minutes for 15 days post-SRP
Device: Emanate Perio PODS
Emanate Perio PODS used 2x/day for 30 minutes use
No Intervention: Group B - Control
No treatment post-SRP (Control Group)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness on periodontal wound healing compared to the historical treatment effect of non-surgical therapy
Time Frame: 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
60 Days post non-surgical therapy
Feasibility of usage of the Emanate Perio PODS twice a day group
Time Frame: Day 15
Feasibility will be characterized by compliance at Day 15 post non-surgical therapy
Day 15
Feasibility of usage of the Emanate Perio PODS twice a day group
Time Frame: Pre-treatment, Day 15, Day 30
Feasibility will be characterized by Dropout rate pre-treatment and at day 15 and Day 30
Pre-treatment, Day 15, Day 30
Feasibility of usage of the Emanate Perio PODS twice a day group
Time Frame: 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
Pre-treatment, Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGuire Institute

Collaborators

Emanate Biomedical Inc.

Investigators

  • Study Director: Jarret Fass, Emanate Biomedical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EB2025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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