Periodontal DiseasesITSNCT03161301
Role of IL-37 Genetic Variants in Modulating Innate Immune Response to Periodontal Pathogens
An observational study of Periodontal Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2015to 24 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Periodontal Diseases
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | IL-37 genotype 1.1 | |
| Group 2 | IL-37 genotype 1.2 | |
| Group 3 | IL-37 genotype 2.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines
Levels of key cytokines in gingival crevicular fluid.
Measured: 6 weeks
Gingival Tissue Expression
Levels of IL-37 expressed in gingival tissue samples obtained during routine periodontal treatments.(Immunohistological)
Measured: Baseline
Whole Blood and Monocyte Cytokines
Evaluation of cytokine levels in LPS stimulated whole blood and monocytes
Measured: 6 weeks
mRNA splice variants
Alternate IL-37 mRNA splice variants of gingival tissue among 1.1, 1.2, and 2.2
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start7 May 2015
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Silvana Barros, DDS PhD MS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161301
- Sponsor's protocol ID
- 15-0335
- Other IDs
- R01DE023836
- Acronym
- ITS
- Status last verified
- Sep 2019
- First submitted
- 17 May 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of IL-37 Genetic Variants in Modulating Innate Immune Response to Periodontal Pathogens
- ClinicalTrials.gov ID
- NCT03161301
- Acronym / sponsor ID
- ITS / 15-0335
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 7 May 2015 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –IL-37 genotype 1.1 |
| Group 2 | – | –IL-37 genotype 1.2 |
| Group 3 | – | –IL-37 genotype 2.2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvana Barros, DDS PhD MS principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.