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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03762915
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : May 2, 2022
Sponsor:
Collaborator:
Bausch Health Companies, INC.
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.


Condition or disease Intervention/treatment Phase
SRP Minocycline HCl Microspheres Biomarkers Drug: minocycline HCl microspheres Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SRP with minocycline HCl microspheres
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
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 Name: Arestin
No Intervention: SRP without minocycline HCl microspheres
The control group will not have minocycline HCl microspheres, 1 mg administered.


Outcome Measures
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Primary Outcome Measures :
  1. Change of Pathogenic Burden [ Time Frame: baseline, 1, 3, and 6 months ]
    Scale 0-100


Other Outcome Measures:
  1. GCF markers [ Time Frame: baseline, 1, 3, and 6 months ]
    Change in picograms per mililitre (pg/ML)

  2. Serum Markers [ Time Frame: baseline, 1, 3, and 6 months ]
    Change in picograms per mililitre (pg/ML) to known reference range


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and Female
  • At least 21 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762915


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Bausch Health Companies, INC.
Investigators
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Principal Investigator: Michelle Arnett University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03762915    
Other Study ID Numbers: DENT-2018-27312
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Minocycline
Anti-Bacterial Agents
Anti-Infective Agents