Atlas of Experimental Gingivitis in Humans

Gingivitis Clinical Trial

— ATL  

Official title:

An Atlas of Experimental Gingivitis in Humans at Single Cell Resolution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105569
• Other study ID #: 19-0183
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: December 3, 2019

Study information

• Verified date: August 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 all participants.

Participants include recruitment of 6 participants. Following consenting, screening, and enrollment, a customized acrylic stent will be used only on the selected sextant/teeth specified in the protocol, and only during tooth brushing to prevent oral hygiene in selected sextant/teeth. After the completion of the 3-week gingivitis induction phase, participants will enter a 2 week resolution phase. In the resolution phase, participants will reinstate full mouth oral hygiene, with the exception of flossing. Oral prophylaxis will be performed to regain health. During the 3 week gingivitis induction phase, participants will be required to return to the clinic every 7 days for safety checks.

Study 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 (mouth guard), 2 gingival biopsies, 4 subgingival (below the gum line) plaque samples, 4 Gingival Crevicular Fluid (naturally occurring fluid between the gum and teeth) samples, and adult prophylaxis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Procedure:
• Stent-Induced Biofilm Overgrowth
Customized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation.

Locations

Country	Name	City	State
United States	Adams School of Dentistry	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Sunstar, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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