Skip to main content
OpenTrials
Completed

NCT Number: NCT03762915

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

SRP Biomarkers Minocycline HCl Microspheres

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

minocycline HCl microspheres

Drug

Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.

Other names: Arestin

Primary outcomes

  1. Bacteria Load (log10)

    Time frame: Baseline

    This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.

    For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

  2. Bacteria Load (log10)

    Time frame: 3 months

    This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.

    For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

  3. Bacteria Load (log10)

    Time frame: 6 months

    This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.

    For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).

Other outcomes

  1. Gingival Crevicular Fluid (GCF) Markers

    Time frame: baseline, 1, 3, and 6 months

    mean

  2. Serum Markers

    Time frame: baseline

    mean C-Reactive Protein (CRP)

  3. Serum Markers

    Time frame: 1 month

    mean CRP

  4. Serum Markers

    Time frame: 3 months

    mean CRP

  5. Serum Markers

    Time frame: 6 months

    mean CRP

  6. Glycated Hemoglobin (HbA1c)

    Time frame: baseline

  7. HbA1c

    Time frame: 1 month

  8. HbA1c

    Time frame: 3 months

  9. HbA1c

    Time frame: 6 months

  10. Mean Haptoglobin (Hp)

    Time frame: baseline

  11. Mean Hp

    Time frame: 1 month

  12. Mean Hp

    Time frame: 3 months

  13. Mean Hp

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study title

Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2018
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.