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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGuire Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emanate Biomedical Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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