Periodontitis (Stage 3)NCT06914596
A Clinical Trial Comparing 2x/Day for 30-minutes Use of the Emanate Perio PODS Post-SRP to a Control Group Post-SRP.
A study testing Emanate Perio PODS in people with Periodontitis (Stage 3), run by McGuire Institute at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Periodontitis (Stage 3)
- What is being tested?
- Emanate Perio PODS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Feb 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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. A maximum of 3 teeth and not more than 6 sites with a PD of 9 mm is acceptable if the tooth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater.
- 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.
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- 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.
Who cannot join
- Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
- Periodontal surgery, implant placement or SRP within 12 months prior to screening; surgical and simple tooth extractions or a cleaning/prophylaxis within 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.
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- 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) including but not limited to:
- Anticonvulsants: Phenytoin, Phenobarbital, Sodium Valproate (Valproic Acid), Lamotrigine, Vigabatrin, Ethosuximide, Topiramate, Primidone.
- Calcium Channel Blockers (CCBs): Nifedipine, Amlodipine, Diltiazem, Verapamil, Felodipine
- Immunosuppressants: Cyclosporine, Tacrolimus, Sirolimus (Rapamycin), Everolimus.
- Oral Contraceptives: Hormonal therapies containing high levels of estrogen or progesterone.
- Certain Psychotropic Medications: Pimozide (antipsychotic); Sertraline, Paroxetine (antidepressants).
- 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.
- Subjects that are known to be hypersensitive to chlorhexidine gluconate, glycerin, polyvinyl alcohol or ethylene vinyl acetate.
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
The Perio Studio
Boston, Massachusetts, 02108
Irina Dragan, DMD, DDS, MS, eMBA, 617-523-2459, i.dragan@themcguireinstitute.org
Nika Mehrnia, 617-523-2459, nika_mehrnia@hsdm.harvard.edu
- Recruiting
Regenerative Solutions
Fullerton, California, 92835
Mylea Hunter, DDS, MS, RDH, 714-441-0436, myleahunter@gmail.com
Monica Trementozzi, RDH, 714-441-0436, edu1@fullertonperio.com
- Recruiting
Perio Health Professionals
Houston, Texas, 77063
Michael McGuire, DDS, FICD, FACD, 713-783-5442, amrperio@periohealth.com
Carol Waring, RDH, 713-783-5442, carol@periohealth.com
- Recruiting
Perio Health Professionals
Houston, Texas, 77063
E. Todd Scheyer, DDS, MS, 713-783-5442, etsperio@periohealth.com
Carol Waring, RDH, 713-783-5442, carol@periohealth.com
- Recruiting
Metro West Orthodontics & Periodontics
La Vista, Nebraska, 68128
Takanari Miyamoto, DDS,MBA, 402-614-7022, takanarimiyamoto@aol.com
Courtney Rudick, 402-614-7022, cpr.mwdsg@gmail.com
- Recruiting
Shoreline Periodontics and Dental Implants
New London, Connecticut, 06320
Gregory Toback, DMD,MS, 860-776-6240, drtoback@shorelineperio.com
Stephanie Rook, 207-212-0624, srooks@shorelineperio.com
- Recruiting
Glazier Implants + Periodontics
Richmond, Virginia, 23226
Thomas Glazier, DDS,MSD, 804-531-4551, glazierdds@gmail.com
Lauren Glazier, 804-531-4551, lglazier125@gmail.com
- Recruiting
Periodontal Center of Excellence, PLLC
Spring, Texas, 77380
Ali Sajadi, DDS, MSD, FACD, FICD, 281-292-1833, alisajadi@periocenter.com
Jan Pope, 281-292-1833, jpope@periocenter.com
- Recruiting
Gulf Coast Periodontics
Victoria, Texas, 77904
Lisha Edwards, 3615731014, l.edwards@themcguireinstitute.org
Rick Heard, DDS, MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis (Stage 3)
- Being tested
- Emanate Perio PODS
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emanate Perio PODSDevice
Emanate Perio PODS used 2x/day for 30 minutes use
| Study group | Role | What they receive |
|---|---|---|
| Group A - 2x/day PODS | Experimental | Emanate Perio PODS used 2x/day for 30 minutes for 15 days post-SRP Receives: Device: Emanate Perio PODS |
| Group B - Control | No intervention | No treatment post-SRP (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 Days post non-surgical therapy
Secondary outcomes (2)
Effectiveness on periodontal wound healing compared to control
As evidenced by change in Modified Gingival Index (MGI)
Measured: 60 Days post non-surgical therapy
Effectiveness on periodontal wound healing compared to control
As evidenced by change change in Pocket Depth (PD) over time in sites with baseline pockets >/=4mm
Measured: 60 Days post non-surgical therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start19 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis (Stage 3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a 105-day(including 45 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGuire Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emanate Biomedical Inc.
- Responsible party
- Sponsor
- Investigators
- Jarret Fass, Study director, Emanate Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914596
- Sponsor's protocol ID
- EB2025-01
- Status last verified
- Mar 2026
- First submitted
- 30 Dec 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06914596
- Acronym / sponsor ID
- EB2025-01
- Conditions
- Periodontitis (Stage 3)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- McGuire InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Emanate Biomedical Inc.
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a 105-day(including 45 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.
| Arm | Type | Receives |
|---|---|---|
| Group A - 2x/day PODS | Experimental | Device: Emanate Perio PODSEmanate Perio PODS used 2x/day for 30 minutes for 15 days post-SRP |
| Group B - Control | No intervention | –No treatment post-SRP (Control Group) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- Subjects 30 to 75 years of age.
- 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. A maximum of 3 teeth and not more than 6 sites with a PD of 9 mm is acceptable if the tooth is not clinically diagnosed as hopeless tooth with suppuration or mobility Grade 3 or greater.
- 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.
Key exclusion criteria (23 listed)
- Subjects who meet the above inclusion criteria will be eligible for the study, unless they present with any of the following:
- Periodontal surgery, implant placement or SRP within 12 months prior to screening; surgical and simple tooth extractions or a cleaning/prophylaxis within 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emanate Perio PODSEmanate Perio PODS used 2x/day for 30 minutes use | Device | Group A - 2x/day PODS |
Primary outcome
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
2 secondary outcomes
Effectiveness on periodontal wound healing compared to control
Time frame: 60 Days post non-surgical therapy
Effectiveness on periodontal wound healing compared to control
Time frame: 60 Days post non-surgical therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jarret Fass study director
Emanate Biomedical
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emanate Perio PODS in people with Periodontitis (Stage 3), run by McGuire Institute at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Fuqua (6159457118, j.fuqua@themcguireinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.