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Phase 4 N=70 Randomized Treatment

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

SRP · Minocycline HCl Microspheres · Biomarkers

Bottom Line

View on ClinicalTrials.gov: NCT03762915 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Bacteria Load (log10) — -11.3; -10.9 log 10 copies/mL

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
minocycline HCl microspheres (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Minnesota
Primary completion
Apr 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Bacteria Load (log10)		 -10.3; -9.6 —
PRIMARY
Bacteria Load (log10)		 -10.3; -9.6 —
PRIMARY
Bacteria Load (log10)		 -10.3; -9.6 —

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.

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03762915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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