Periodontitis Clinical Trial
Official title:
IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
A maximum of 220 subjects with a minimum of 25 years will be recruited and examined for this
1-7 visit, up to 35 days research study: Subjects will be genotyped to identify variants of
the interleukin-29 (IL29) and interleukin-28B (IL28B) genes and placed in one of the 4
groups: 50 subjects with dominant allelic variants with healthy periodontium, 50 subjects
with dominant allelic variants with periodontitis, 50 subjects with IL29 (rs30461) or any of
IL28B (rs11083519; rs8105790; rs8099917) single nucleotide polymorphism's (SNP) variants and
healthy periodontium, and 50 subjects with IL29 (rs30461) or any of IL28B (rs11083519;
rs8105790; rs8099917) SNP variants and periodontitis. Visits will consist of outpatient
procedures including oral examinations, oral prophylaxis or periodontal scaling and root
planing, collection of gingival crevicular fluid, dental plaque, saliva, and blood samples.
Analysis will include salivary DNA isolation and pyrosequencing to determine IL29 and IL28B
genotype, mediator analysis of gingival crevicular fluid, dendritic cell differentiation and
inflammatory mediator analysis, and whole-genome shotgun sequencing plaque analysis. Clinical
outcomes will include measurements of periodontal disease progression and inflammation, such
as clinical attachment level (CAL), pocket depth (PD), bleeding on probing (BOP), gingival
index (GI), and plaque index (PI).
Primary Objective: To determine the impact of IL29 and IL28B SNP variants on periodontal
disease expression and local inflammatory response during stent-induced biofilm overgrowth.
Secondary Objective: To evaluate in vitro the impact of IL29 and IL28B SNP variants on
cell-mediated, innate inflammatory response.
n/a
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