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NCT04105569 · ClinicalTrials.gov registry record · NA
Atlas of Experimental Gingivitis in Humans
A NA study of Gingivitis, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04105569: Completed NA study of Gingivitis, sponsored by University of North Carolina, Chapel Hill.
NCT04105569 is a NA study of Gingivitis that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 6 participants, below the 236-participant average among 25 other Gingivitis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04105569, a NA study of Gingivitis, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Pilot case series with a split-mouth design to track subjects with known exposure (dental biofilm accumulation) over 21 days. Descriptive design, using single cell RNA sequencing as a "digital biopsy" to catalog and contrast inflamed versus non-inflamed tissues from within the same mouth and across patients. Specimens (human) will biobanked from the 'digital biopsy' site for future analysis, including: Gingival crevicular fluid, oral epithelial stem/progenitor cells, and plaque samples, for 'omics analyses including metabolomics, microbiomic, and genomic data.
Primary Outcome
Percentage of the human gingival biopsies that are epithelial, immune, or mesenchymal cells in health.
Conditions Studied
Interventions
- PROCEDURE Stent-Induced Biofilm Overgrowth
Study Locations (1)
North Carolina
- Adams School of Dentistry - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2019-12-03 |
| Phase | NA |
What the finished NCT04105569 record still lists
NCT04105569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 236-participant average among 25 other Gingivitis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Gingivitis appearing as the primary indexed condition, and to 1 intervention - of which Stent-Induced Biofilm Overgrowth is the first listed.
NCT04105569 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04105569 about?
NCT04105569 is a clinical study titled "Atlas of Experimental Gingivitis in Humans". Pilot case series with a split-mouth design to track subjects with known exposure (dental biofilm accumulation) over 21 days. Descriptive design, using single cell RNA sequencing as a "digital biopsy" to catalog and contrast inflamed versus non-inflamed tissues from within the same mouth and across ...
What is the current status of trial NCT04105569?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2019-10-15. Estimated completion is 2019-12-03.
What conditions does trial NCT04105569 study?
This clinical trial studies the following conditions: Gingivitis.
What interventions are being tested in trial NCT04105569?
The interventions under investigation include: Stent-Induced Biofilm Overgrowth (PROCEDURE).
Who is sponsoring clinical trial NCT04105569?
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 NCT04105569 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
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04105569's enrollment target sits among peer trials
6 26th of 25 the lowest of 25 other Gingivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gingivitis 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.
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