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IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis

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ClinicalTrials.gov Identifier: NCT02710903
Recruitment Status : Enrolling by invitation
First Posted : March 17, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Periodontitis Procedure: Stent-induced biofilm overgrowth Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IL29 and IL28B Variants Associated With Periodontal Disease Pathogenesis
Study Start Date : May 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease

Arm Intervention/treatment
Experimental: Healthy with Dominant IL28B and IL29
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).
Procedure: Stent-induced biofilm overgrowth
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

Experimental: Periodontal Disease with Dominant IL28B and IL29
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.
Procedure: Stent-induced biofilm overgrowth
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

Experimental: Healthy with IL28B and/or IL29 SNP variants
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.
Procedure: Stent-induced biofilm overgrowth
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

Experimental: Periodontal Disease with IL28B and/or IL29 SNP variants
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.
Procedure: Stent-induced biofilm overgrowth
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 Measures :
  1. Change in pocket depth (mm) [ Time Frame: 21 days ]
  2. Change in clinical attachment level (mm) [ Time Frame: 21 days ]
  3. Change in plaque index (0-3) [ Time Frame: 21 days ]
  4. Change in bleeding on probing (Yes/No) [ Time Frame: 21 days ]
  5. Change in gingival crevicular fluid interleukin-1 beta (GCF IL-1b) [ Time Frame: 21 days ]
  6. Change in gingival crevicular fluid prostaglandin E2 (GCF PGE2) [ Time Frame: 21 days ]
  7. Change in gingival crevicular fluid interleukin-29 (GCF IL-29) [ Time Frame: 21 days ]
  8. Change in gingival crevicular fluid interleukin-28B (GCF IL-28B) [ Time Frame: 21 days ]
  9. Change in gingival index (0-4) [ Time Frame: 21 days ]
  10. Composition of the microbiota oral flora [ Time Frame: 21 days ]
  11. Change in gingival crevicular fluid interleukin-6 (GCF IL-6) [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Change in interleukin-29 expression in dendritic cells at day 35 [ Time Frame: 35 days ]
  2. Change in interleukin-28B expression in dendritic cells at day 35 [ Time Frame: 35 days ]


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710903


Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Thiago Morelli, DDS, MS University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02710903     History of Changes
Other Study ID Numbers: 15-0637
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by University of North Carolina, Chapel Hill:
Periodontitis
SNP
Pathogenesis
IL29
IL28B

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases