Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02710903
Status:
TERMINATED
Last Update Posted:
2019-09-26
First Post:
2015-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5K23DE025093-02 | NIH | None | https://reporter.nih.gov/quic… | View |
| 5K23DE025093-03 | NIH | None | https://reporter.nih.gov/quic… | View |