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Report for Clinical Trial NCT02710903

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT02710903 Periodontitis
MeSH: Periodontitis Periodontal Diseases
HPO: Periodontitis

1 Interventions

Name: Stent-induced biofilm overgrowth

Description: Customized stents will be fabricated for each subject. Stents will be fabricated to resemble an acrylic mouth-guard but extended to cover approximately 2mm over gingival margins. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will abstained from brushing and flossing teeth in one maxillary and one mandibular posterior sextant during a three- week period. Patients will be monitored for safety every week and after the induction of experimental biofilm overgrowth through 21 days

Type: Procedure

Healthy with Dominant IL28B and IL29 Healthy with IL28B and/or IL29 SNP variants Periodontal Disease with Dominant IL28B and IL29 Periodontal Disease with IL28B and/or IL29 SNP variants


Primary Outcomes

Measure: Change in pocket depth (mm)

Time: 21 days

Measure: Change in clinical attachment level (mm)

Time: 21 days

Measure: Change in plaque index (0-3)

Time: 21 days

Measure: Change in bleeding on probing (Yes/No)

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b)

Time: 21 days

Measure: Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2)

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-29 (GCF IL-29)

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-28B (GCF IL-28B)

Time: 21 days

Measure: Change in gingival index (0-4)

Time: 21 days

Measure: Composition of the microbiota oral flora

Time: 21 days

Measure: Change in gingival crevicular fluid interleukin-6 (GCF IL-6)

Time: 21 days

Secondary Outcomes

Measure: Change in interleukin-29 expression in dendritic cells at day 35

Time: 35 days

Measure: Change in interleukin-28B expression in dendritic cells at day 35

Time: 35 days

Purpose: Diagnostic

Allocation: Non-Randomized

Single Group Assignment


There are 4 SNPs

SNPs


1 rs11083519

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.


2 rs30461

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.


3 rs8099917

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.


4 rs8105790

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.



HPO Nodes


HPO:
Periodontitis
Genes 41
PLG GORAB PLG DKC1 FGF3 CTSC CTSC AP3B1 SLC35C1 ELANE NOTCH2 CTSC PLG RTEL1 CXCR4 TERC PARN GFI1 TCIRG1 FERMT1 OCRL ELANE C1S SRP54 ITGB2 C1R USB1 CTC1 LYST NOP10 COL3A1 NPM1 WRAP53 C1S TERT COL3A1 C1R NHP2 CTSC TINF2 FERMT1