45 Participants Needed

Impact of Daily Use of The Emanate Tray Adjunct to Full Mouth Debridement Compared to Full Mouth Debridement Alone

JF
Overseen ByJarret Fass
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a combination of thorough teeth cleaning and a special treatment tray for patients with moderate to severe gum disease. The cleaning removes harmful substances, and the tray applies extra treatment directly to the gums.

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 safety data exists for the treatment known as Emanate Tray?

The research articles discuss the importance of adverse event reporting in clinical trials, which is crucial for determining the safety of treatments. However, they do not provide specific safety data for the treatment known as Emanate Tray.12345

How does this treatment differ from other treatments for Clostridium perfringens-related diseases?

This treatment is unique because it targets the germination process of Clostridium perfringens spores, which is crucial for their survival and pathogenicity. By focusing on the specific proteins involved in spore germination, it offers a novel approach compared to traditional treatments that may not address this critical stage of the bacterial life cycle.678910

Eligibility Criteria

Inclusion Criteria

Provision of signed, written informed consent prior to participation in any study-related procedures.
Good general health as evidenced by medical history.
At least 18 years of age at time of informed consent signature.
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Timeline

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

Treatment Details

Interventions

  • Emanate Tray
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group (Emanate Tray)Experimental Treatment1 Intervention
Full mouth periodontal debridement + Emanate Tray (treatment group)
Group II: Control GroupActive Control1 Intervention
Full mouth periodontal debridement alone (control group)

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Who Is Running the Clinical Trial?

Emanate Biomedical Inc.

Lead Sponsor

Trials
1
Recruited
50+

Findings from Research

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

References

Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children's Oncology Group Report. [2023]
Methods and Issues to Consider for Detection of Safety Signals From Spontaneous Reporting Databases: A Report of the DIA Bayesian Safety Signal Detection Working Group. [2020]
Systematic identification and classification of adverse events in human research. [2006]
Adverse event reporting in publications compared with sponsor database for cancer clinical trials. [2007]
Adverse event reporting for cellular therapy products: Current status and future directions. [2021]
A mother cell-to-forespore channel: current understanding and future challenges. [2022]
Inorganic phosphate induces spore morphogenesis and enterotoxin production in the intestinal pathogen Clostridium perfringens. [2018]
Array-based transcriptional analysis of Clostridium sporogenes UC9000 during germination, cell outgrowth and vegetative life. [2012]
Characterization of germinants and their receptors for spores of non-food-borne Clostridium perfringens strain F4969. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Bacterial Endospores as Phage Genome Carriers and Protective Shells. [2019]