University of Washington
Seattle, Washington, 98195, United States
Location status: Recruiting
Location contact
Jeffrey S McLean, PhD
CONTACT
Kristopher A Kerns, PhD
SUB_INVESTIGATOR
Marilyn Rothen
CONTACT
NCT Number: NCT05968742
The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumulation and maturation of dental plaque.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98195, United States
Location status: Recruiting
Jeffrey S McLean, PhD
CONTACT
Kristopher A Kerns, PhD
SUB_INVESTIGATOR
Marilyn Rothen
CONTACT
This study will employ the split-mouth Experimental Gingivitis model where healthy study participants are asked to abstain from oral hygiene on a select set of teeth (test teeth) for a period of 21 days. The study consists of 3 phases; Hygiene Phase (Day -14-0), Experimental Induction Phase (Day 0-21), and Resolution Phase (Day 21-35). Abstaining from oral hygiene on the test teeth will result in the natural accumulation and maturation of dental plaque (a bacterial biofilm) on the tooth surface which will in induce a host inflammatory response. By investigating the onset of microbially induced inflammation directly in humans using this highly utilized and well-described experimental gingivitis model, the research community are able to better understand the host-microbial interactions during the initiation, induction of host response, and resolution of mucosal inflammation at the molecular level. The investigators central hypothesis is based on our previous experimental gingivitis studies conducted here at the University of Washington Bamashmous et al. Human Variation in Gingival Inflammation PNAS 2021 and NCT03750955. The investigators hypothesize that specific clinical inflammatory response phenotypes (High, Low and Slow responders) are dependent upon both microbial factors regulating the subgingival plaque growth and maturation rate as well as host factors regulating the human gingival inflammatory mediator levels and type.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study participants abstain from oral hygiene on a select set of four teeth for a period of 21 days
Other names: Split Mouth Experimental Gingivitis
Time frame: Day 0 to Day 21
Identification of clinical responder types through comparative analysis of the levels of clinical parameter for Bleeding on Probing Index (% BOP) at Day 14 of the plaque overgrowth/induction phase measured by calibrated examiners.
Time frame: Day 0 to Day 21
The rate of change in relative abundance of gram positive Firmicutes bacteria compared to that of gram negative Bacteroidetes bacteria through the plaque overgrowth/induction phase (Day 0-21) assessed through 16S rRNA and Metagenomic Sequencing.
Contact information is provided by the study sponsor or research team.
University of Washington
Other
Mechanisms Underlying the Variation in Rate and Levels of Gingival Inflammatory Responses Among the Human Population
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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