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NCT03513497 · ClinicalTrials.gov registry record · NA
IFI16 is a Periodontitis Modulating Protein
A NA study of Severe Periodontitis and Acute Inflammatory Response, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT03513497: Completed NA study of Severe Periodontitis and Acute Inflammatory Response, sponsored by University of North Carolina, Chapel Hill.
NCT03513497 is a NA study of Severe Periodontitis and Acute Inflammatory Response that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03513497, a NA study of Severe Periodontitis and Acute Inflammatory Response, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
To characterize the expression of Interferon gamma inducible protein 16 (IFI16) and Absent in melanoma 2 (AIM2) in gingival tissues in an inflammatory response using an acrylic mouthguard (also referred to as a stent) induced bacteria overgrowth method. Participants: 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. Procedures (methods): Medical history, demographics, (height/weight), urine based pregnancy test, vital signs (to include blood pressures, and pulse) standard dental clinical measures (to include plaque index, gingival index, bleeding on probing, and clinical attachment level), alginate impressions taken for fabrication of an acrylic stent (mouthguard), 2 gingival biopsies, 2 subgingival (below the gumline) plaque samples, and Scaling Root planing (SRP)/or adult prophylaxis
Primary Outcome
Gingival tissues derived from study participants were evaluated for AIM2 mRNA expression at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Gene expression was evaluated by quantitative reverse transcription polymerase chain reaction (qRT-PCR) and quantified by the delta-delta-CT method.
Conditions Studied
Interventions
- OTHER Customized acrylic mouthguard
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2023-06-28 |
| Phase | NA |
What the finished NCT03513497 record still lists
NCT03513497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Severe Periodontitis appearing as the primary indexed condition, and to 1 intervention - of which Customized acrylic mouthguard is the first listed.
NCT03513497 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03513497 about?
NCT03513497 is a clinical study titled "IFI16 is a Periodontitis Modulating Protein". To characterize the expression of Interferon gamma inducible protein 16 (IFI16) and Absent in melanoma 2 (AIM2) in gingival tissues in an inflammatory response using an acrylic mouthguard (also referred to as a stent) induced bacteria overgrowth method. Participants: A maximum of 72 Adult subjects ...
What is the current status of trial NCT03513497?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2018-10-18. Estimated completion is 2023-06-28.
What conditions does trial NCT03513497 study?
This clinical trial studies the following conditions: Severe Periodontitis, Acute Inflammatory Response.
What interventions are being tested in trial NCT03513497?
The interventions under investigation include: Customized acrylic mouthguard (OTHER).
Who is sponsoring clinical trial NCT03513497?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513497 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03513497's enrollment target sits among peer trials
69 1133rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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