Back to resultsIL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
Primary Purpose
Periodontitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stent-induced biofilm overgrowth
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontitis focused on measuring Periodontitis, SNP, Pathogenesis, IL29, IL28B
Eligibility Criteria
Inclusion Criteria:
- Subjects must have read, understood and signed an informed consent form in English.
- Subjects must be able and willing to follow study procedures and instructions in English.
- Subjects must be non-Hispanic Caucasian.
- Subjects must be adult males or females with a minimum of 25 years (inclusive).
- Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
- Subjects must have at least 3 teeth in each posterior sextant.
- Subjects must be in good general health.
- Subjects must present with one of the following four categories to be considered for enrollment:
- Dominant IL28B and IL29 allelic with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
- 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.
- IL28B or IL29 SNP variants with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
- 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
Exclusion Criteria:
- Chronic disease with oral manifestations including diabetes mellitus.
- Current smoker or one that has stopped smoking less than 2 years prior to enrollment.
- Gross oral pathology other than the periodontal disease.
- Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
- Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.
- Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
- Significant organ disease including impaired renal function, heart murmur, history of rheumatic fever or valvular disease, or any bleeding disorder.
- Infectious diseases such as hepatitis, HIV or tuberculosis.
- Anemia or other blood dyscrasias.
- Anticoagulant therapy or drugs, such as heparin or warfarin.
- Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the trial.
- Pregnant, or expect to become pregnant within the next several months.
- Females of child-bearing capacity must be willing to have pregnancy test to confirm they are not pregnant.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy with Dominant IL28B and IL29
Periodontal Disease with Dominant IL28B and IL29
Healthy with IL28B and/or IL29 SNP variants
Periodontal Disease with IL28B and/or IL29 SNP variants
Arm Description
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).
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in pocket depth (mm)
Change in clinical attachment level (mm)
Change in plaque index (0-3)
Change in bleeding on probing (Yes/No)
Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b)
Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2)
Change in gingival crevicular fluid interleukin-29 (GCF IL-29)
Change in gingival crevicular fluid interleukin-28B (GCF IL-28B)
Change in gingival index (0-4)
Composition of the microbiota oral flora
Change in gingival crevicular fluid interleukin-6 (GCF IL-6)
Secondary Outcome Measures
Change in interleukin-29 expression in dendritic cells at day 35
Change in interleukin-28B expression in dendritic cells at day 35
Full Information
NCT ID
NCT02710903
First Posted
December 8, 2015
Last Updated
September 24, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT02710903
Brief Title
IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
Official Title
IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, SNP, Pathogenesis, IL29, IL28B
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy with Dominant IL28B and IL29
Arm Type
Experimental
Arm Description
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).
Arm Title
Periodontal Disease with Dominant IL28B and IL29
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy with IL28B and/or IL29 SNP variants
Arm Type
Experimental
Arm Description
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.
Arm Title
Periodontal Disease with IL28B and/or IL29 SNP variants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stent-induced biofilm overgrowth
Intervention 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
Primary Outcome Measure Information:
Title
Change in pocket depth (mm)
Time Frame
21 days
Title
Change in clinical attachment level (mm)
Time Frame
21 days
Title
Change in plaque index (0-3)
Time Frame
21 days
Title
Change in bleeding on probing (Yes/No)
Time Frame
21 days
Title
Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b)
Time Frame
21 days
Title
Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2)
Time Frame
21 days
Title
Change in gingival crevicular fluid interleukin-29 (GCF IL-29)
Time Frame
21 days
Title
Change in gingival crevicular fluid interleukin-28B (GCF IL-28B)
Time Frame
21 days
Title
Change in gingival index (0-4)
Time Frame
21 days
Title
Composition of the microbiota oral flora
Time Frame
21 days
Title
Change in gingival crevicular fluid interleukin-6 (GCF IL-6)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Change in interleukin-29 expression in dendritic cells at day 35
Time Frame
35 days
Title
Change in interleukin-28B expression in dendritic cells at day 35
Time Frame
35 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must have read, understood and signed an informed consent form in English.
Subjects must be able and willing to follow study procedures and instructions in English.
Subjects must be non-Hispanic Caucasian.
Subjects must be adult males or females with a minimum of 25 years (inclusive).
Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
Subjects must have at least 3 teeth in each posterior sextant.
Subjects must be in good general health.
Subjects must present with one of the following four categories to be considered for enrollment:
Dominant IL28B and IL29 allelic with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
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.
IL28B or IL29 SNP variants with PD ≤4mm, no evidence of interproximal CAL, and <20% of sites with BOP.
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
Exclusion Criteria:
Chronic disease with oral manifestations including diabetes mellitus.
Current smoker or one that has stopped smoking less than 2 years prior to enrollment.
Gross oral pathology other than the periodontal disease.
Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.
Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
Significant organ disease including impaired renal function, heart murmur, history of rheumatic fever or valvular disease, or any bleeding disorder.
Infectious diseases such as hepatitis, HIV or tuberculosis.
Anemia or other blood dyscrasias.
Anticoagulant therapy or drugs, such as heparin or warfarin.
Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the trial.
Pregnant, or expect to become pregnant within the next several months.
Females of child-bearing capacity must be willing to have pregnancy test to confirm they are not pregnant.
Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Beck, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
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