Clinical trial NCT04312542: Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy
Official title: Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1mg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SRP
Minocycline HCl Microspheres
Biomarkers
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from a randomized controlled clinical trial approved by the University of Minnesota (UMN) Institutional Review Board (IRB) STUDY00004876 and registered on ClinicalTrials.gov (NCT03762915) identifying the effects of SRP with and without minocycline HCl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.

Brief summary: The primary goal of this study is to determine the amount of three systemic markers of inflammation: 1) Hemoglobin A1c (Hgb A1c, 2) High Sensitivity C-Reactive Protein (hsCRP), and 3) Haptoglobin (Hp) at 9 and 12 month follow-up post scaling and rootplaning (SRP) with and without minocycline HCl microspheres, 1 mg.

Detailed description: Participants from a randomized controlled clinical trial approved by the University of Minnesota (UMN) Institutional Review Board (IRB) STUDY00004876 and registered on ClinicalTrials.gov (NCT03762915) identifying the effects of SRP with and without minocycline HCl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.

Eligibility criteria: Inclusion Criteria:

- Participated in interventional phase of the trial STUDY00004876

Exclusion Criteria:

* Unable to comply with study protocol
* 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)

Primary outcomes:
measure: Serum Hemoglobin A1C Concentration
timeFrame: 9 months
measure: Serum Hemoglobin A1C Concentration
timeFrame: 12 months
measure: Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration
timeFrame: 9 months
measure: Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration
timeFrame: 12 months
measure: Serum Haptoglobin Concentration
timeFrame: 9 months
measure: Serum Haptoglobin Concentration
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michelle B Arnett, RDH, BS, MS
role: PRINCIPAL_INVESTIGATOR
References: