Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg

University of Minnesota (UMN)

Status and phase: Completed; Phase 4

Conditions: Biomarkers; Minocycline HCl Microspheres; SRP

Treatments: Drug: minocycline HCl microspheres

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03762915

DENT-2018-27312

Details and patient eligibility

About

The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load.

A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.

Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period.

Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.

Full description

A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.

The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. Saliva samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and TNF-α.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and Female
• At least 18 years of age
• ADA Class III-IV Chronic Periodontitis
• Scaling and Root Planing (SRP) or localized SRP
• A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)

Exclusion criteria

• Unable to comply with study protocol
• Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months
• 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.)
• Tetracycline allergy
• Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, cyclosporin, warfarin, or NSAIDS)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

SRP with minocycline HCl microspheres

Experimental group

Description:

The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.

Treatment:

Drug: minocycline HCl microspheres

SRP without minocycline HCl microspheres

No Intervention group

Description:

The control group will not have minocycline HCl microspheres, 1 mg administered.