Emanate Perio PODS for Severe Gum Disease

Not yet recruiting at 6 trial locations
AG
Overseen ByAverie Garcia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new periodontal hydrogel dressing, Emanate Perio PODS, enhances healing in severe gum disease better than no treatment after deep cleaning. Participants will be divided into groups: one will use the gel overnight, another will use it twice a day, and a control group will receive no additional treatment. The trial aims to determine if the gel improves healing in individuals with severe gum disease after cleaning. Ideal participants have experienced severe gum disease with deep gum pockets for at least a year and are willing to avoid certain dental products during the study. As an unphased trial, this study allows participants to contribute to innovative dental research that could improve future treatments.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take medications that affect gum conditions, regular antibiotics, corticosteroids, or certain pain and blood-thinning medications. It's best to discuss your current medications with the trial team to see if any changes are needed.

What prior data suggests that Emanate Perio PODS is safe for treating severe gum disease?

Research has shown that treatments using chlorhexidine, such as Emanate Perio PODS, are generally safe for treating gum disease. Chlorhexidine, a common ingredient, helps reduce bacteria in the mouth. Many studies have found it to be well-tolerated by patients. Although detailed information specifically about Emanate Perio PODS is limited, these findings suggest it could be safe for individuals with severe gum disease. It is always important to consult a healthcare provider about any concerns before joining a trial.12345

Why are researchers excited about this trial?

Unlike the standard treatments for severe gum disease, which often involve antibiotics and more invasive procedures, Emanate Perio PODS represent a novel approach by employing a localized delivery method. This treatment is unique because it's designed to target the affected area directly, potentially enhancing effectiveness while minimizing systemic side effects. Researchers are particularly excited about the convenience and potential for rapid results, as one group uses the PODS overnight while another applies them twice a day for just 30 minutes. This innovative strategy could offer a more patient-friendly and efficient way to manage severe gum disease.

What evidence suggests that Emanate Perio PODS is effective for severe gum disease?

Research has shown that treatments like Emanate Perio PODS, similar to ozone therapy, can help treat gum disease by promoting healing and fighting infections. Studies suggest these therapies improve wound healing after plaque and tartar removal from teeth. In this trial, participants will join different groups to test the effectiveness of Emanate Perio PODS. Group A will use the PODS overnight for 14 days post-SRP, while Group B will use them twice a day for 30 minutes over the same period. Group C will serve as a control with no treatment post-SRP. Emanate Perio PODS use a special gel to enhance the healing process. Early results from similar treatments have shown promise in improving gum health and reducing severe gum disease symptoms. Overall, this approach is expected to help people with periodontitis recover faster and achieve better results.12678

Who Is on the Research Team?

JF

Jarret Fass

Principal Investigator

Emanate Biomedical

Are You a Good Fit for This Trial?

This trial is for people with generalized stage III periodontitis, a severe form of gum disease. Participants must have had plaque and tartar removed from their teeth recently. Specific inclusion or exclusion criteria are not provided, but typically participants should be in stable health and meet certain age requirements.

Inclusion Criteria

Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
I agree not to use electric flossers or irrigation devices.
I have advanced gum disease with specific gum and tooth measurements.
See 6 more

Exclusion Criteria

Presence of fixed or removable orthodontic appliances.
Known hypersensitivity to specific substances.
I have had recent dental surgery or treatment.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Emanate Perio PODS dressing post-SRP for 14 days, either overnight or 2x/day for 30 minutes

2 weeks
Daily application

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measures assessed at 60 days post non-surgical therapy

60 days

What Are the Treatments Tested in This Trial?

Interventions

  • Emanate Perio PODS
Trial Overview The study tests the Emanate Perio PODS, which are hydrogel dressings applied to gums after dental cleaning procedures. It compares healing outcomes when used overnight versus twice daily for 30 minutes over two weeks, followed by standard oral care practices.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Group B - 2x/day PODSExperimental Treatment1 Intervention
Group II: Group A - Overnight PODSExperimental Treatment1 Intervention
Group III: Group C - ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McGuire Institute

Lead Sponsor

Trials
7
Recruited
390+

Emanate Biomedical Inc.

Industry Sponsor

Trials
1
Recruited
50+

Citations

Emanate Perio PODS for Severe Gum DiseaseThe use of ozone therapy, which is similar to the treatment in Emanate Perio PODS, has shown benefits in treating gum disease by helping heal infections and ...
Emanate Perio PODS At no cost to you, your dentist feels ...This clinical study would assess the effectiveness of a Periodontal Hydrogel Dressing. (Emanate Perio PODS) on wound healing post non-surgical therapy (scaling ...
PeriodontitisIntegrated disease information for Periodontitis including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 data ...
Advances in novel therapeutic approaches for periodontal ...In this review, we summarize the recent advancement of alternative methods and new compounds that offer promising potential for the treatment ...
https://clinicaltrials.gov/study/NCT06127069?cond=...No information is available for this page.
NCT01234948No information is available for this page.
Periodontal Disease in Adults (Age 30 or Older)Per CDC/AAP, severe periodontitis is defined as having 2 or more interproximal sites with clinical attachment loss (CAL) 6 mm or greater (not on the same tooth) ...
Emanate Perio PODS in Periodontitis (Stage 3) - ICH GCPIn this study, the Emanate Perio PODS dressing is applied for 30 minutes and overnight immediately after toothbrushing and interdental cleaning ...
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