Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy

Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1mg

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04312542

Enrollment

Registered

2020-03-18

Start date

2020-07-21

Completion date

2022-08-16

Last updated

2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers, Minocycline HCl Microspheres, SRP

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.

Interventions

PROCEDUREMeasurement of Biomarkers

Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Serum Hemoglobin A1C Concentration	9 months	Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes).
Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration	9 months	Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l.
Serum Haptoglobin Concentration	9 months	Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026