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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DE025093-02 | U.S. NIH Grant/Contract | View source | |
| 5K23DE025093-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy with Dominant IL28B and IL29 | Experimental | Stent-induced biofilm overgrowth model will be used in dominant IL28B and IL29 allelic with probing depths (PD) ≤4mm, no evidence of inter proximal clinical attachment loss (CAL), and <20% of sites with bleeding on probing (BOP). |
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| Periodontal Disease with Dominant IL28B and IL29 | Experimental | Stent-induced biofilm overgrowth model will be used in dominant IL28B and IL29 allelic with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP. |
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| Healthy with IL28B and/or IL29 SNP variants | Experimental | Stent-induced biofilm overgrowth model will be used in IL28B or IL29 SNP variants with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP. |
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| Periodontal Disease with IL28B and/or IL29 SNP variants | Experimental | Stent-induced biofilm overgrowth model will be used in IL28B or IL29 SNP variants with the presence of at least four periodontal sites with PD ≥ 5mm, evidence of interproximal CAL, and ≥20% of sites with BOP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent-induced biofilm overgrowth | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pocket depth (mm) | 21 days | |
| Change in clinical attachment level (mm) | 21 days | |
| Change in plaque index (0-3) | 21 days | |
| Change in bleeding on probing (Yes/No) | 21 days | |
| Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b) | 21 days | |
| Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2) | 21 days | |
| Change in gingival crevicular fluid interleukin-29 (GCF IL-29) | 21 days | |
| Change in gingival crevicular fluid interleukin-28B (GCF IL-28B) | 21 days | |
| Change in gingival index (0-4) | 21 days | |
| Composition of the microbiota oral flora | 21 days | |
| Change in gingival crevicular fluid interleukin-6 (GCF IL-6) | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in interleukin-29 expression in dendritic cells at day 35 | 35 days | |
| Change in interleukin-28B expression in dendritic cells at day 35 | 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Beck, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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