Emanate Perio PODS for Severe Gum Disease

Recruiting at 6 trial locations

Overseen By Averie Garcia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGuire Institute

Must not be taking: Antibiotics, Corticosteroids, Anticoagulants, NSAIDs

Disqualifiers: Orthodontic appliances, Smoked substances, Uncontrolled conditions, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

111 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Emanate Perio PODS for severe gum disease?

The 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 improve outcomes in patients with aggressive periodontitis. This suggests that Emanate Perio PODS might also be effective in managing severe gum disease. ^{1 2 3 4 5}

Is Emanate Perio PODS safe for use in humans?

The safety of chlorhexidine-based treatments, similar to Emanate Perio PODS, has been evaluated in studies for gum disease, showing they are generally safe with some benefits in improving gum health. ^{6 7 8 9 10}

How does the drug Emanate Perio PODS differ from other treatments for severe gum disease?

Emanate Perio PODS is unique because it may involve a novel delivery system or formulation that allows for targeted application directly into periodontal pockets, potentially maintaining effective drug concentrations for longer periods compared to traditional treatments. This could enhance its effectiveness in treating severe gum disease by ensuring sustained exposure to the active ingredients. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Jarret Fass

Principal Investigator

Emanate Biomedical

Eligibility Criteria

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.

Exclusion Criteria

I have had recent dental surgery or treatment.

Presence of fixed or removable orthodontic appliances.

Known hypersensitivity to specific substances.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Group B - 2x/day PODS Experimental Treatment 1 Intervention

Emanate Perio PODS used 2x/day for 30 minutes for 14 days post-SRP

Group II: Group A - Overnight PODS Experimental Treatment 1 Intervention

Overnight use of Emanate Perio PODS for 14 days post-SRP

Group III: Group C - Control Active Control 1 Intervention

No treatment post-SRP (Control Group)

Who Is Running the Clinical Trial?

McGuire Institute

Lead Sponsor

Trials

7

Recruited

390+

Emanate Biomedical Inc.

Industry Sponsor

Trials

1

Recruited

50+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Treatment of an Endo-Perio Lesion with Ozone Gas in a Patient with Aggressive Periodontitis: A Clinical Case Report and Literature Review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The clinical and microbiological effects of systemic ornidazole in sites with and without subgingival debridement in early-onset periodontitis patients. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Prognostic factors in the treatment of generalized aggressive periodontitis: I. Clinical features and initial outcome. [2006]

4. India pubmed.ncbi.nlm.nih.gov

Efficacy of Ozonised Water and 0.2% Chlorhexidine Gluconate in the Management of Chronic Periodontitis when Used as an Irrigant in Conjugation with Phase I Therapy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Prognostic criteria for the efficiency of non-surgical periodontal therapy in advanced periodontitis. [2019]

6. China pubmed.ncbi.nlm.nih.gov

[The efficacy of the chlorhexidine chip following scaling and root planing (SRP) and compared to SRP alone]. [2013]

7. Italy pubmed.ncbi.nlm.nih.gov

Chlorhexidine gel used as antiseptic in periodontal pockets. [2021]

8. Hungary pubmed.ncbi.nlm.nih.gov

Effects of periodontal dressings on fibroblasts and gingival wound healing in dogs. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

In vivo evaluation of a metronidazole-containing gel for the adjuvant treatment of chronic periodontitis: preliminary results. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of local metronidazole in the treatment of chronic periodontitis. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Concentration of metronidazole in periodontal pockets after application of a metronidazole 25% dental gel. [2019]

12. China pubmed.ncbi.nlm.nih.gov

[Garlicin and formocresol in the treatment of chronic periapical periodontitis]. [2016]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Antimicrobial Chemotherapy for Recalcitrant Severe Human Periodontitis. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Effect of Subgingival Irrigation with Different Substances in the Treatment of Periodontal Disease. A Histometric Study in Rats. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Case Series Report of 66 Refractory Maintenance Patients Evaluating the Effectiveness of Topical Oxidizing Agents. [2016]