Role of IL-37 Genetic Variants in Modulating Innate Immune Response to Periodontal Pathogens


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Verified May 2017 by University of North Carolina, Chapel Hill

Sponsor:

Collaborator:

National Institute of Dental and Craniofacial Research (NIDCR)

Information provided by (Responsible Party):

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT03161301

First received: May 17, 2017

Last updated: May 18, 2017

Last verified: May 2017

This study will provide mechanistic insight into the underlying causes and molecular level pathogenesis of periodontal diseases. We will identify key mechanisms that confer risk and protection. Ultimately this will lead to new and improved diagnostics and therapeutics. Because periodontal disease is a uniquely accessible biofilm-associated disease it will provide insight into many other diseases such as inflammatory bowel disease and chronic infections associated with indwelling catheters and artificial prostheses. Subjects with periodontal conditions will have therapeutic benefit from the treatments provided.

Periodontal Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Role of IL-37 Genetic Variants in Modulating Innate Immune Response to Periodontal Pathogens

Primary Outcome Measures:

  • Cytokines [ Time Frame: 6 weeks ]

    Levels of key cytokines in gingival crevicular fluid.

  • Gingival Tissue Expression [ Time Frame: Baseline ]

    Levels of IL-37 expressed in gingival tissue samples obtained during routine periodontal treatments.(Immunohistological)

  • Whole Blood and Monocyte Cytokines [ Time Frame: 6 weeks ]

    Evaluation of cytokine levels in LPS stimulated whole blood and monocytes

  • mRNA splice variants [ Time Frame: Baseline ]

    Alternate IL-37 mRNA splice variants of gingival tissue among 1.1, 1.2, and 2.2

Biospecimen Retention:   Samples With DNA

Saliva, subgingival dental plaque, gingival cervicular fluid and interdental gingival biopsy tissue.

Estimated Enrollment: 93
Actual Study Start Date: May 7, 2015
Estimated Study Completion Date: August 1, 2020
Estimated Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)
Group 1

IL-37 genotype 1.1

Group 2

IL-37 genotype 1.2

Group 3

IL-37 genotype 2.2

A maximum of 440 subjects will be enrolled in this study with the goal of identifying 31 of each of the three types of IL-37 genotypes (93 total). Subject participation may include 1 to 9 visits lasting over a period of 6 months. Clinical data and medical history data will be collected at the screening visit to ascertain eligibility. Saliva collected at screening will be used to determine genotype. If one of the three targeted genotypes results, these patients will be assigned to the appropriate genotype group until 31 subjects are in each group at which point recruitment and screening will stop. There are no plans to share genotype classification with subjects. All subjects will have saliva and dental plaque collected at baseline. Twenty four of the 93 subjects (8 from each group) will be selected for gingival biopsy. These 24 subjects will have GCF samples collected at baseline. All subjects will have GCF samples collected at visit 3. Enrolled subjects (31 of each type of the three genotypes) will be recalled up to four additional times spread over twelve weeks for blood collection, to be used for monocyte isolation and whole blood stimulation. Gingival tissue samples will be used for immunohistochemistry, laser capture and RNA extraction. Medical histories, demographics, height and weight, clinical and biological data described above will be recorded and stored on a secure server located at the University of North Carolina. Each participant enrolled into the study will have a unique identification number that has been stripped of any information that could be used by non-study members to identify the subject.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample

adult Caucasian male and female subjects recruited from the patients, students and staff at the University of North Carolina at Chapel Hill, as well as the general population in or near Chapel Hill NC.

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 adult Caucasian males or females between the ages of 18 and 65 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.

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03161301

UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Contact: S.T. Phillips, BSDH    919-537-3422    sherrill_phillips@unc.edu   
Sub-Investigator: Silvana Barros, DDS, MS, PhD         
Sub-Investigator: Steven Kim, DDS, PhD         
Sub-Investigator: Julie Marchesan, DDS, PhD         
Sub-Investigator: Shaoping Zhang, DDS, MS, PhD         

University of North Carolina, Chapel Hill

National Institute of Dental and Craniofacial Research (NIDCR)

Principal Investigator: Steven Offenbacher, DDS, PhD, MMSc University of North Carolina, Chapel Hill

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2017