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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Periodontal Diseases

Clinical Trial Details

NCT number	NCT03161301
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase
Start date	May 7, 2015
Completion date	May 24, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms