Atlas of Experimental Gingivitis in Humans

Completed · Not applicable

Conditions studied: Gingivitis

In brief

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.

Key facts

Study ID

NCT04105569

Run by

University of North Carolina, Chapel Hill

People needed

6

Starts

2019-10-15

Expected to finish

2019-12-03

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult males or females between the age of 18 and 30 years.
• Non-diabetic and no history of smoking within the last 5 years.
• Have read, understood and signed an informed consent form.
• Must be able and willing to follow study procedures and instructions.
• Must have at least 3 natural adjacent teeth in both maxillary (top) posterior sextants that will be selected for baseline gingival biopsy and SIBO gingival biopsy.
• Must be in good general health, as evidenced by medical hx (exclusion conditions defined under subject exclusion criteria below).
• Females of childbearing capacity must be willing to have pregnancy test to confirm they are not pregnant.

You may not qualify if…

• History of intravenous bisphosphonates.
• Current or history (less than 5 years) of tobacco use in any form prior to enrollment (self-report)
• Chronic disease with oral manifestations including diabetes mellitus.
• Infectious disease such as hepatitis, HIV, or tuberculosis.
• Anemia or other blood dyscrasias.
• Currently taking anticoagulant therapy or drugs, such as heparin or warfarin.
• Those requiring antibiotic prophylaxis prior to dental treatment
• Exhibiting gross oral pathology or a history of periodontal disease.
• Individuals with a history or are currently using birth control containing hormones.
• Individuals without a history (less than 1 year) of regular professional oral health care, including prophylaxis. (self-report)
• Pregnant, breastfeeding or planning for pregnancy within 3 months.
• Individuals who used antibiotics/chronically used NSAIDs
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Where it is running

• Adams School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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