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

Completed

Conditions studied: Periodontal Diseases

In brief

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.

Key facts

Study ID

NCT03161301

Run by

University of North Carolina, Chapel Hill

People needed

86

Starts

2015-05-07

Expected to finish

2019-05-24

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.