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Customized acrylic mouthguard for Gum Disease (IFI Trial)

N/A
Waitlist Available
Led By Julie T Marchesan, DDS, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 0), visit 5 (day 21)
Awards & highlights

IFI Trial Summary

This trial is to study the expression of IFI16 and AIM2 in gingival tissues in an inflammatory response using an acrylic mouthguard (also referred to as a stent) induced bacteria overgrowth method. A maximum of 72 Adult subjects will be recruited from the patients, students and staff at the University of North Carolina, as well as the general population in or near Chapel Hill NC.

Eligible Conditions
  • Gum Disease
  • Acute Inflammatory Response

IFI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 0), visit 5 (day 21)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0), visit 5 (day 21) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean AIM2 mRNA fold change
Mean IFI16 mRNA fold change
Percentage of SIBO-induced AIM2 positive cells
+1 more
Secondary outcome measures
Percent periodontal pathogens by expression of AIM2 and IFI16

IFI Trial Design

2Treatment groups
Experimental Treatment
Group I: Periodontal Profile Class (PPC-G)Experimental Treatment1 Intervention
Participants with severe periodontal disease (PPC-G) will wear customized acrylic mouthguard only during tooth brushing for 21 days.
Group II: Periodontal Profile Class (PPC-A)Experimental Treatment1 Intervention
Periodontally healthy participants (PPC-A) will wear customized acrylic mouthguard only during tooth brushing for 21 days.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,499 Previous Clinical Trials
4,176,223 Total Patients Enrolled
1 Trials studying Gum Disease
270 Patients Enrolled for Gum Disease
National Institute of Dental and Craniofacial Research (NIDCR)NIH
297 Previous Clinical Trials
847,176 Total Patients Enrolled
Julie T Marchesan, DDS, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this clinical experiment?

"Indeed, the data hosted on clinicaltrials.gov points to this investigation being open for recruitment. This experiment, which was initially posted on October 18th 2018 and modified most recently on April 25th 2022, is aiming to enrol 72 patients from a single location."

Answered by AI

Are there still openings for volunteers in this research project?

"Yes, the information found on clinicaltrials.gov affirms that this experiment is proactively enrolling participants. Initially posted on October 18th 2018 and most recently amended April 25th 2022, it seeks to enlist 72 patients from a single location."

Answered by AI
~11 spots leftby Mar 2025