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Atlas of Experimental Gingivitis in Humans (ATL)

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ClinicalTrials.gov Identifier: NCT04105569
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Sunstar, Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Gingivitis Procedure: Stent-Induced Biofilm Overgrowth Not Applicable

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Atlas of Experimental Gingivitis in Humans at Single Cell Resolution
Actual Study Start Date : October 15, 2019
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : December 3, 2019

Arm Intervention/treatment
Experimental: Healthy Volunteers
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
Customized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation.
Other Name: Dental Stent




Primary Outcome Measures :
  1. Percent Composition of Human Gingival Tissue at Day 1 [ Time Frame: Day 1 ]
    Percentage of the human gingival biopsies that are epithelial, immune, or mesenchymal cells in health.

  2. Percent Composition of Human Gingival Tissue at Day 21 [ Time Frame: Day 21 ]
    Percentage of the human gingival biopsies that are epithelial, immune, or mesenchymal cells during inflammation.

  3. Percent Composition of Human Gingival Epithelial Cells at Day 1 [ Time Frame: Day 1 ]
    Percentage of the human gingival epithelial cell subtypes that are present (i.e. keratinocytes, Langerhans cells, etc.) in health.

  4. Percent Composition of Human Gingival Epithelial Cells at Day 21 [ Time Frame: Day 21 ]
    Percentage of the human gingival epithelial cell subtypes that are present (i.e. keratinocytes, Langerhans cells, etc.) during inflammation.

  5. Percent Composition of Human Gingival Immune Cells at Day 1 [ Time Frame: Day 1 ]
    Percentage of the human immune cell subtypes that are present (i.e. CD4, CD8, etc.) in health.

  6. Percent Composition of Human Gingival Immune Cells at Day 21 [ Time Frame: Day 21 ]
    Percentage of the human immune cell subtypes that are present (i.e. CD4, CD8, etc.) during inflammation.

  7. Percent Composition of Human Gingival Mesenchymal Cells at Day 1 [ Time Frame: Day 1 ]
    Percentage of the human mesenchymal cell subtypes that are present (i.e. stromal endothelial, etc.) in health.

  8. Percent Composition of Human Gingival Mesenchymal Cells at Day 21 [ Time Frame: Day 21 ]
    Percentage of the human mesenchymal cell subtypes that are present (i.e. stromal endothelial, etc.) in health.

  9. Genes Expressed In Epithelial Cells at Day 1 [ Time Frame: 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.

  10. Genes Expressed In Epithelial Cells at Day 21 [ Time Frame: 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.

  11. Genes Expressed In Immune Cells at Day 1 [ Time Frame: 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.

  12. Genes Expressed In Immune Cells at Day 21 [ Time Frame: 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.

  13. Genes Expressed In Mesenchymal Cells at Day 1 [ Time Frame: 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.

  14. Genes Expressed In Mesenchymal Cells at Day 21 [ Time Frame: 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.

  15. Genes Expressed In Epithelial Cell Subtypes at Day 1 [ Time Frame: 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.

  16. Genes Expressed In Epithelial Cell Subtypes at Day 21 [ Time Frame: 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.

  17. Genes Expressed In Immune Cell Subtypes at Day 1 [ Time Frame: 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.

  18. Genes Expressed In Immune Cell Subtypes at Day 21 [ Time Frame: 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.

  19. Genes Expressed In Mesenchymal Cell Subtypes at Day 1 [ Time Frame: 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.

  20. Genes Expressed In Mesenchymal Cell Subtypes at Day 21 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105569


Locations
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United States, North Carolina
Adams School of Dentistry
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Sunstar, Inc.
Investigators
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Principal Investigator: Kevin M Byrd, DDS, PhD Adams School of Dentistry, UNC Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04105569    
Other Study ID Numbers: 19-0183
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Single-cell RNA sequencing data will be shared through the Gene Expression Omnibus (GEO), a public functional genomics data repository supporting MIAME-compliant data submissions, which accepts sequence-based data. Gene list data will be searchable, cell by cell, through an online database. The files will be deposited both as raw reads (.fastq) and differential gene expression (.txt and .xlsx). Once data have been cleaned, assessed for differential gene expression, and validated by FISH/IHC, data will be made public. This will allow us to make this data freely available for others to investigate and reanalyze for their own purposes to accelerate further discoveries.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases