Recruiting

Periodontal Hydrogel

Sponsor:

McGuire Institute

Code:

NCT06914596

Conditions

Periodontitis (Stage 3)

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Emanate Perio PODS

Study Details

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)

Study ID

NCT06914596

Start date

Feb 19, 2026

Status verified date

Mar, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A - 2x/day PODS

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

no intervention: Group B - Control

No treatment post-SRP (Control Group)

Interventions

Emanate Perio PODS

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Regenerative Solutions

Recruiting

Fullerton, California, United States, 92835

Contacts

Mylea Hunter, DDS, MS, RDH

714-441-0436myleahunter@gmail.com

Principal Investigator:

Mylea Hunter, DDS, MS, RDH

Shoreline Periodontics and Dental Implants

Recruiting

New London, Connecticut, United States, 06320

Contacts

Principal Investigator:

Geogory Toback, DMD,MS

The Perio Studio

Recruiting

Boston, Massachusetts, United States, 02108

Contacts

Principal Investigator:

Irina Dragan, DMD, DDS, MS, eMBA

Metro West Orthodontics & Periodontics

Recruiting

La Vista, Nebraska, United States, 68128

Contacts

Principal Investigator:

Takanari Miyamoto, DDS,MBA

Perio Health Professionals

Recruiting

Houston, Texas, United States, 77063

Contacts

Michael McGuire, DDS, FICD, FACD

713-783-5442amrperio@periohealth.com

Principal Investigator:

Michael McGuire, DDS, FICD, FACD

Perio Health Professionals

Recruiting

Houston, Texas, United States, 77063

Contacts

Principal Investigator:

E. Todd Scheyer, DDS, MS

Periodontal Center of Excellence, PLLC

Recruiting

Spring, Texas, United States, 77380

Contacts

Principal Investigator:

Ali Sajadi, DDS, MDS, FACD, FICD

Glazier Implants + Periodontics

Recruiting

Richmond, Virginia, United States, 23226

Contacts

Principal Investigator:

Thomas Glazier, DDS,MSD

More Information

Sponsor

McGuire Institute

Last update posted

Jun 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by McGuire Institute on 2026-06-24.