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

NCT06914596 | Recruiting FDA Device

• 1 other identifier: EB2025-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 9

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.

Conditions

Periodontitis (Stage 3)

Outcome Measures

Primary Outcomes (1)

• Effectiveness on periodontal wound healing compared to control as evidenced by the presence/absence of gingival bleeding

  Change in Bleeding on Marginal Probing (BOMP) over time at 60 Days post non-surgical therapy

  60 Days post non-surgical therapy

Secondary Outcomes (2)

• Effectiveness on periodontal wound healing compared to control

  60 Days post non-surgical therapy

• Effectiveness on periodontal wound healing compared to control

  60 Days post non-surgical therapy

Other Outcomes (4)

• Effectiveness on periodontal wound healing compared to the historical treatment effect of non-surgical therapy

  60 Days post non-surgical therapy

• Feasibility of usage of the Emanate Perio PODS twice a day group

  Day 15

• Feasibility of usage of the Emanate Perio PODS twice a day group

  Pre-treatment, Day 15, Day 30

Study Arms (2)

Group A - 2x/day PODS

EXPERIMENTAL

Emanate Perio PODS used 2x/day for 30 minutes for 15 days post-SRP

Device: Emanate Perio PODS

Group B - Control

NO INTERVENTION

No treatment post-SRP (Control Group)

Interventions

Emanate Perio PODS DEVICE

Emanate Perio PODS used 2x/day for 30 minutes use

Group A - 2x/day PODS

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the following criteria to be entered into the study:
• Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
• Subjects 30 to 75 years of age.
• 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
• Subjects have a minimum of 24 natural teeth with a minimum of 2 natural teeth per quadrant excluding third molars.
• 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.
• 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.).
• Subjects agree to refrain from use of electric flossers or irrigation devices for the duration of the study.
• Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
• Subjects are able and willing to follow study procedures and instructions.

You may not qualify if:

• Periodontal surgery, implant placement or SRP within 12 months prior to screening or a cleaning/prophylaxis three months prior to screening.
• Presence of fixed or removable (e.g. Invisalign) orthodontic appliances.
• Subject with an underlying medical condition which requires antibiotic prophylaxis prior to dental treatment.
• Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
• Subjects with soft or hard tissue tumor(s) of oral cavity.
• 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.
• Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer).
• Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
• Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia).
• Regular, prolonged use of oral antimicrobial rinses 30 days prior to screening or continued anticipated use through their projected study duration.
• Use of systemic antibiotics 30 days prior to screening or anticipated during the trial period.
• Subjects taking corticosteroids on a regular basis one week prior to baseline examination and throughout the duration of the study, including oral inhalers.
• 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.
• Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis.
• Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental) within 30 days of Screening.

Sponsors & Collaborators

• McGuire Institute: lead
• Emanate Biomedical Inc.: collaborator

Study Sites (9)

Regenerative Solutions

Fullerton, California, 92835, United States

RECRUITING

Shoreline Periodontics and Dental Implants

New London, Connecticut, 06320, United States

RECRUITING

The Perio Studio

Boston, Massachusetts, 02108, United States

NOT YET RECRUITING

Metro West Orthodontics & Periodontics

La Vista, Nebraska, 68128, United States

RECRUITING

Perio Health Professionals

Houston, Texas, 77063, United States

RECRUITING

Perio Health Professionals

Houston, Texas, 77063, United States

RECRUITING

Periodontal Center of Excellence, PLLC

Spring, Texas, 77380, United States

RECRUITING

Glazier Implants + Periodontics

Richmond, Virginia, 23226, United States

RECRUITING

Seattle Periodontist and Implant Dentistry

Seattle, Washington, 98101, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jarret Fass

  Emanate Biomedical

  STUDY DIRECTOR

Central Study Contacts

Jill Fuqua

CONTACT

6159457118; j.fuqua@themcguireinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: At each study site, study roles will be designated such that the blinded examiner procedures will be separate from the clinicians conducting the other evaluations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 90-day(including 30 day screening), randomized, examiner-blind, controlled, two-armed, parallel group, multisite clinical trial comparing 2x/day for 30-minutes use of the Emanate Perio PODS post-SRP\* over a 15-day treatment period followed by the Standard of Care\*\* (SOC) to investigate the effects of different regiments on safety, tolerability, and periodontal wound healing.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: April 6, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)