Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy
NCT ID: NCT04312542
Last Updated: 2022-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-07-21
2022-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SRP with minocycline HCl microspheres
Participants in this cohort received the intervention of minocycline HCl microspheres, 1 mg in the interventional phase of the trial.
Measurement of Biomarkers
Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.
SRP without minocycline HCl microspheres
Participants in this cohort did not have minocycline HCl microspheres, 1 mg administered during the interventional phase of the trial.
Measurement of Biomarkers
Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.
Interventions
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Measurement of Biomarkers
Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Cigarette use within the last year
* ≥2 weeks of antibiotic use in the past three months or antibiotic use in the last six weeks.
* Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
* Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
* Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c \> 7, HIV, etc.)
* Any medication that may impact periodontal conditions (Phenytoin, calciumantagonists, cyclosporin, warfarin, or NSAIDS)
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Michelle B Arnett, RDH, BS, MS
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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DENT-2020-28624
Identifier Type: -
Identifier Source: org_study_id
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