Clinical trial NCT03762915: Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg
Official title: Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: SRP
Minocycline HCl Microspheres
Biomarkers
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2018-12-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Bacteria Load (log10)
timeFrame: Baseline
measure: Bacteria Load (log10)
timeFrame: 3 months
measure: Bacteria Load (log10)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Gingival Crevicular Fluid (GCF) Markers
timeFrame: baseline, 1, 3, and 6 months
measure: Serum Markers
timeFrame: baseline
measure: Serum Markers
timeFrame: 1 month
measure: Serum Markers
timeFrame: 3 months
measure: Serum Markers
timeFrame: 6 months
measure: Glycated Hemoglobin (HbA1c)
timeFrame: baseline
measure: HbA1c
timeFrame: 1 month
measure: HbA1c
timeFrame: 3 months
measure: HbA1c
timeFrame: 6 months
measure: Mean Haptoglobin (Hp)
timeFrame: baseline
measure: Mean Hp
timeFrame: 1 month
measure: Mean Hp
timeFrame: 3 months
measure: Mean Hp
timeFrame: 6 months
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michelle Arnett
role: PRINCIPAL_INVESTIGATOR
References: