Atlas of Experimental Gingivitis in Humans

NCT04105569 | Completed

• 1 other identifier: 19-0183
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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" 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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (20)

• Percent Composition of Human Gingival Tissue at Day 1

  Percentage of the human gingival biopsies that are epithelial, immune, or mesenchymal cells in health.

  Day 1

• Percent Composition of Human Gingival Tissue at Day 21

  Percentage of the human gingival biopsies that are epithelial, immune, or mesenchymal cells during inflammation.

  Day 21

• Percent Composition of Human Gingival Epithelial Cells at Day 1

  Percentage of the human gingival epithelial cell subtypes that are present (i.e. keratinocytes, Langerhans cells, etc.) in health.

  Day 1

• Percent Composition of Human Gingival Epithelial Cells at Day 21

  Percentage of the human gingival epithelial cell subtypes that are present (i.e. keratinocytes, Langerhans cells, etc.) during inflammation.

  Day 21

• Percent Composition of Human Gingival Immune Cells at Day 1

  Percentage of the human immune cell subtypes that are present (i.e. CD4, CD8, etc.) in health.

  Day 1

• Percent Composition of Human Gingival Immune Cells at Day 21

  Percentage of the human immune cell subtypes that are present (i.e. CD4, CD8, etc.) during inflammation.

  Day 21

• Percent Composition of Human Gingival Mesenchymal Cells at Day 1

  Percentage of the human mesenchymal cell subtypes that are present (i.e. stromal endothelial, etc.) in health.

  Day 1

• Percent Composition of Human Gingival Mesenchymal Cells at Day 21

  Percentage of the human mesenchymal cell subtypes that are present (i.e. stromal endothelial, etc.) in health.

  Day 21

• Genes Expressed In Epithelial Cells at Day 1

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in epithelial cells in health will be produced.

  Day 1

• Genes Expressed In Epithelial Cells at Day 21

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in epithelial cells during inflammation will be produced.

  Day 21

• Genes Expressed In Immune Cells at Day 1

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in immune cells in health will be produced.

  Day 1

• Genes Expressed In Immune Cells at Day 21

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in immune cells during inflammation will be produced.

  Day 21

• Genes Expressed In Mesenchymal Cells at Day 1

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in mesenchymal cells in health will be produced.

  Day 1

• Genes Expressed In Mesenchymal Cells at Day 21

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in mesenchymal cells during inflammation will be produced.

  Day 21

• Genes Expressed In Epithelial Cell Subtypes at Day 1

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in epithelial cell subtypes in health will be produced.

  Day 1

• Genes Expressed In Epithelial Cell Subtypes at Day 21

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in epithelial cell subtypes during inflammation will be produced.

  Day 21

• Genes Expressed In Immune Cell Subtypes at Day 1

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in immune cell subtypes in health will be produced.

  Day 1

• Genes Expressed In Immune Cell Subtypes at Day 21

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in immune cell subtypes during inflammation will be produced.

  Day 21

• Genes Expressed In Mesenchymal Cell Subtypes at Day 1

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in mesenchymal cell subtypes in health will be produced.

  Day 1

• Genes Expressed In Mesenchymal Cell Subtypes at Day 21

  Gene expression will be ranked by highest to lowest and a list of the top 100 genes in mesenchymal cell subtypes during inflammation will be produced.

  Day 21

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Enrolled subjects will be included in an experimental gingivitis model (SIBO) for 21 days and use an acrylic stent fabricated before and dispensed at the baseline appointment

Procedure: Stent-Induced Biofilm Overgrowth

Interventions

Stent-Induced Biofilm Overgrowth PROCEDURE

Customized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation.

Also known as: Dental Stent

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

You may not qualify if:

• Females of childbearing capacity must be willing to have pregnancy test to confirm they are not pregnant.
• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Sunstar, Inc.: collaborator

Study Sites (1)

Adams School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kevin M Byrd, DDS, PhD

  Adams School of Dentistry, UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: October 15, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Gene expression data will be available for download once the manuscript has been accepted for publication.
• Access Criteria: Gene expression lists by cell types will be provided to download freely in association with available journal access.

Locations

US (1)