GingivitisATLNCT04105569
Atlas of Experimental Gingivitis in Humans
A study testing Stent-Induced Biofilm Overgrowth in people with Gingivitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Stent-Induced Biofilm Overgrowth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Adams School of Dentistry
Chapel Hill, North Carolina, 27599
About this study
Official title: An Atlas of Experimental Gingivitis in Humans at Single Cell Resolution
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.
Read the 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
- Conditions
- Gingivitis
- Being tested
- Stent-Induced Biofilm Overgrowth
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent-Induced Biofilm OvergrowthProcedure or surgery
Also called Dental Stent
Customized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Stent-Induced Biofilm Overgrowth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Composition of Human Gingival Tissue at Day 1
Percentage of the human gingival biopsies that are epithelial, immune, or mesenchymal cells in health.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start15 Oct 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstar, Inc.
- Responsible party
- Sponsor
- Investigators
- Kevin M Byrd, DDS, PhD, Principal investigator, Adams School of Dentistry, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105569
- Sponsor's protocol ID
- 19-0183
- Acronym
- ATL
- Status last verified
- Aug 2020
- First submitted
- 24 Sep 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Atlas of Experimental Gingivitis in Humans at Single Cell Resolution
- ClinicalTrials.gov ID
- NCT04105569
- Acronym / sponsor ID
- ATL / 19-0183
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Sunstar, Inc.
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Procedure: Stent-Induced Biofilm OvergrowthEnrolled 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent-Induced Biofilm OvergrowthAlso: Dental StentCustomized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation. | Procedure or surgery | Healthy Volunteers |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin M Byrd, DDS, PhD principal investigator
Adams School of Dentistry, UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent-Induced Biofilm Overgrowth in people with Gingivitis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Composition of Human Gingival Tissue at Day 1 (time frame: Day 1). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.