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

NCT03762915 | Completed Phase 4 Results FDA Drug

• 1 other identifier: DENT-2018-27312
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

SRP; Minocycline HCl Microspheres; Biomarkers

Outcome Measures

Primary Outcomes (3)

• Bacteria Load (log10)

  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).

  Baseline

• Bacteria Load (log10)

  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 months

• Bacteria Load (log10)

  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).

  6 months

Other Outcomes (13)

• Gingival Crevicular Fluid (GCF) Markers

  baseline, 1, 3, and 6 months

• Serum Markers

  baseline

• Serum Markers

  1 month

Study Arms (2)

SRP with minocycline HCl microspheres

EXPERIMENTAL

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

Drug: minocycline HCl microspheres

SRP without minocycline HCl microspheres

NO INTERVENTION

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

Interventions

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.

Also known as: Arestin

SRP with minocycline HCl microspheres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Michelle Arnette
• Organization: University of Minnesota

marnett@umn.edu

6126243457

Study Officials

• Michelle Arnett

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 4, 2018
• Study Start: May 20, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 28, 2025
• Results First Posted: March 25, 2024

Record last verified: 2025-01

Locations

US (1)