Status:
COMPLETED
Atlas of Experimental Gingivitis in Humans
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Sunstar, Inc.
Conditions:
Gingivitis
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief 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"...
Detailed Description
Purpose is to conduct the first study of human gingiva in health and after biofilm-induced inflammation in the gingiva using scRNAseq. The pilot will involve induction of experimental gingivitis in al...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04105569
Start Date
October 15 2019
End Date
December 3 2019
Last Update
August 12 2020
Active Locations (1)
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1
Adams School of Dentistry
Chapel Hill, North Carolina, United States, 27599