- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03762915
Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg
Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
No Intervention: SRP without minocycline HCl microspheres
The control group will not have minocycline HCl microspheres, 1 mg administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Baseline
|
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 months
|
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). |
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 3 months
|
3 months
|
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HbA1c
Time Frame: 6 months
|
6 months
|
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HbA1c
Time Frame: 1 month
|
1 month
|
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Gingival Crevicular Fluid (GCF) Markers
Time Frame: baseline, 1, 3, and 6 months
|
mean
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baseline, 1, 3, and 6 months
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Serum Markers
Time Frame: baseline
|
mean C-Reactive Protein (CRP)
|
baseline
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Serum Markers
Time Frame: 1 month
|
mean CRP
|
1 month
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Serum Markers
Time Frame: 3 months
|
mean CRP
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3 months
|
Serum Markers
Time Frame: 6 months
|
mean CRP
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6 months
|
Glycated Hemoglobin (HbA1c)
Time Frame: baseline
|
baseline
|
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Mean Haptoglobin (Hp)
Time Frame: baseline
|
baseline
|
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Mean Hp
Time Frame: 1 month
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1 month
|
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Mean Hp
Time Frame: 3 months
|
3 months
|
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Mean Hp
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Arnett, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DENT-2018-27312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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