Atlas of Experimental Gingivitis in Humans

NCT ID: NCT04105569

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2019-12-03

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Stent-Induced Biofilm Overgrowth

Intervention Type: PROCEDURE

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

Interventions

Stent-Induced Biofilm Overgrowth

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

Intervention Type: PROCEDURE

Other Intervention Names

Dental Stent

Eligibility 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunstar, Inc.

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin M Byrd, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Adams School of Dentistry, UNC Chapel Hill

Locations

Adams School of Dentistry

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

19-0183

Identifier Type: -

Identifier Source: org_study_id