Emanate Tray for Gingivitis

Overseen By Jarret Fass

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emanate Biomedical Inc.

Must not be taking: Antibiotics, Anti-inflammatories, Anticoagulants

Disqualifiers: Smoking, Diabetes, Immunocompromised, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using the Emanate Tray, a dental treatment device, along with dental cleaning (debridement) benefits people with gum disease (Stage II or III periodontitis) more than cleaning alone. Participants will be divided into two groups: one will receive both the cleaning and the Emanate Tray, while the other will receive only the cleaning. Ideal candidates for this trial have gum disease, at least 18 teeth, and experience bleeding gums when brushed or probed. As an unphased trial, this study allows participants to contribute to innovative dental care research that could enhance treatment options for gum disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who use anti-inflammatory medications frequently or have certain medical conditions. It's best to discuss your specific medications with the study team.

What prior data suggests that the Emanate Tray is safe for treating periodontitis?

Research has shown that treatments using chlorhexidine, such as the Emanate Tray, are generally safe for treating gum disease. In previous studies, participants tolerated these treatments well, and no major safety issues were reported. This suggests that the Emanate Tray is likely safe. However, as with any treatment, some individuals might experience minor side effects. Consulting a healthcare professional is advisable if there are any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emanate Tray because it offers a new way to enhance the effectiveness of full mouth periodontal debridement, a common procedure for gum health. Unlike standard care that solely relies on manual cleaning, the Emanate Tray provides an additional method that can potentially improve results. By integrating this tray, which likely targets bacteria more effectively, there is hope for better, faster, and more comprehensive oral health outcomes. This innovative approach could represent a significant step forward in periodontal treatment.

What evidence suggests that the Emanate Tray is effective for periodontitis?

Research has shown that the Emanate Tray, which participants in this trial may receive, can help treat gum disease. Studies have found that similar ozone therapy aids in healing gum infections. The Emanate Tray uses hydrogen peroxide, a safe ingredient used in dentistry for over 10 years. This method has demonstrated positive effects on gum health. Specifically, patients have experienced better healing of gum tissues compared to using traditional treatments alone. These findings suggest the Emanate Tray could improve outcomes for people with gum disease. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Provision of signed, written informed consent prior to participation in any study-related procedures.

Good general health as evidenced by medical history.

Minimum of 18 teeth, excluding third molars.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive full mouth periodontal debridement with or without the Emanate Tray

8 weeks

4 visits (in-person) at Baseline, Day 14, Day 28, and Day 56

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emanate Tray

How Is the Trial Designed?

Group I: Treatment Group (Emanate Tray) Experimental Treatment 1 Intervention

Full mouth periodontal debridement + Emanate Tray (treatment group)

Group II: Control Group Active Control 1 Intervention

Full mouth periodontal debridement alone (control group)

Who Is Running the Clinical Trial?

Emanate Biomedical Inc.

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

A survey of 509 clinical research associates (CRAs) and research nurses (RNs) revealed significant variability in adverse event (AE) reporting practices, with only 51.2% using standardized methods, highlighting a need for improved training and consistency.

Respondents identified major challenges in AE reporting, such as differences in trial protocols and definitions, and expressed strong support for additional resources like online reporting modules and standardized tracking forms to enhance reporting accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report. Miller, TP., Marx, MZ., Henchen, C., et al.[2023]

The University of Connecticut developed a customized online system for tracking and reviewing adverse events in clinical research, which allows for efficient classification and timely reporting of serious incidents.

In the previous academic year, the system reviewed 371 serious adverse events from over 900 studies, demonstrating its effectiveness in ensuring participant safety and providing recommendations for study modifications or suspensions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic identification and classification of adverse events in human research. Silverman, DI., Cirullo, L., DeMartinis, NA., et al.[2006]

Citations

1. withpower.com withpower.com/trial/emanate-perio-pods-for-severe-gum-disease-ebf16

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 ...

2. ctv.veeva.com ctv.veeva.com/study/impact-of-daily-use-of-the-emanate-tray-adjunct-to-full-mouth-debridement-compared-to-full-mouth-deb

Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth ... The study is a 56-day (8-week), randomized, controlled, examiner-blinded, parallel-design study of patients with existing Stage II or Stage ...

3. providers.perioprotect.com providers.perioprotect.com/provider-resources/publications/

Publications - Perio Protect for Providers Hydrogen peroxide has a long and safe track record in dentistry and has been used in tray delivery for more than 10 years to treat periodontal disease.

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06914596

Emanate Perio PODS in Periodontitis (Stage 3) - ICH GCP Effectiveness on periodontal wound healing compared to control. Time Frame: 60 Days post non-surgical therapy. As evidenced by change in Modified Gingival Index ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22779217/

Custom tray application of peroxide gel as an adjunct to ... This study evaluated the clinical effects of SRP alone or combined with local administration of hydrogen peroxide gel using customized trays in the treatment ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25842461/

A 6-month clinical investigation of custom tray application ... 57 subjects completed the trial. Analysis of pockets > 5 mm at baseline showed that mean PPD for both test groups significantly decreased from baseline ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06319261

Efficacy of Guided Biofilm Therapy (GBT) for Treatment ... the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets. the objectives are. 1- To compare ...