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

NCT03161301 | Completed

• 2 other identifiers: 15-0335R01DE023836
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (4)

• Cytokines

  Levels of key cytokines in gingival crevicular fluid.

  6 weeks

• Gingival Tissue Expression

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

  Baseline

• Whole Blood and Monocyte Cytokines

  Evaluation of cytokine levels in LPS stimulated whole blood and monocytes

  6 weeks

• mRNA splice variants

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

  Baseline

Study Arms (3)

Group 1

IL-37 genotype 1.1

Group 2

IL-37 genotype 1.2

Group 3

IL-37 genotype 2.2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Silvana Barros, DDS PhD MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: May 7, 2015
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)