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

University of Minnesota (UMN)

Status: Completed

Conditions: Biomarkers; Minocycline HCl Microspheres; SRP

Treatments: Procedure: Measurement of Biomarkers

Study type: Observational

Funder types: Other

Identifiers

NCT04312542

DENT-2020-28624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

60 participants in 2 patient groups

SRP with minocycline HCl microspheres

Description:

Participants in this cohort received the intervention of minocycline HCl microspheres, 1 mg in the interventional phase of the trial.

Treatment:

Procedure: Measurement of Biomarkers

SRP without minocycline HCl microspheres

Description:

Participants in this cohort did not have minocycline HCl microspheres, 1 mg administered during the interventional phase of the trial.

Treatment:

Procedure: Measurement of Biomarkers