Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg
NCT ID: NCT03762915
Last Updated: 2025-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2019-05-20
2022-04-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
SRP without minocycline HCl microspheres
The control group will not have minocycline HCl microspheres, 1 mg administered.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Michelle Arnett
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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DENT-2018-27312
Identifier Type: -
Identifier Source: org_study_id
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