Status:
COMPLETED
Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
SRP
Minocycline HCl Microspheres
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03762915
Start Date
May 20 2019
End Date
April 1 2022
Last Update
January 28 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455