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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| SRP without minocycline HCl microspheres | No Intervention | The control group will not have minocycline HCl microspheres, 1 mg administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Gingival Crevicular Fluid (GCF) Markers | mean | baseline, 1, 3, and 6 months |
| Serum Markers | mean C-Reactive Protein (CRP) | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Arnett | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | SRP Without Minocycline HCl Microspheres | The control group will not have minocycline HCl microspheres, 1 mg administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | log 10 copies/mL | Baseline |
|
Adverse were collected for each participant for the enrollment period of 6 months. There were no reportable adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Arnette | University of Minnesota | 6126243457 | marnett@umn.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2022 | Jun 6, 2023 | Prot_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2020 | Jun 29, 2023 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Serum Markers | mean CRP | 1 month |
| Serum Markers | mean CRP | 3 months |
| Serum Markers | mean CRP | 6 months |
| Glycated Hemoglobin (HbA1c) | baseline |
| HbA1c | 1 month |
| HbA1c | 3 months |
| HbA1c | 6 months |
| Mean Haptoglobin (Hp) | baseline |
| Mean Hp | 1 month |
| Mean Hp | 3 months |
| Mean Hp | 6 months |
| BG001 | SRP Without Minocycline HCl Microspheres | The control group will not have minocycline HCl microspheres, 1 mg administered. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race/ethnicity data was not collected for all participants | Count of Participants | Participants |
|
| SRP Without Minocycline HCl Microspheres |
The control group will not have minocycline HCl microspheres, 1 mg administered. |
|
|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | log 10 copies/mL | 3 months |
|
|
|
| Primary | 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). | Posted | Mean | 95% Confidence Interval | log 10 copies/mL | 6 months |
|
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| Other Pre-specified | Gingival Crevicular Fluid (GCF) Markers | mean | The lab had issues with the samples and couldnt use them | Posted | baseline, 1, 3, and 6 months |
|
|
| Other Pre-specified | Serum Markers | mean C-Reactive Protein (CRP) | Posted | Mean | Standard Deviation | mg/L | baseline |
|
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| Other Pre-specified | Serum Markers | mean CRP | Posted | Mean | Standard Deviation | mg/L | 1 month |
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| Other Pre-specified | Serum Markers | mean CRP | Posted | Mean | Standard Deviation | mg/L | 3 months |
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| Other Pre-specified | Serum Markers | mean CRP | Posted | Mean | Standard Deviation | mg/L | 6 months |
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| Other Pre-specified | Glycated Hemoglobin (HbA1c) | Posted | Mean | Standard Deviation | percentage | baseline |
|
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| Other Pre-specified | HbA1c | Posted | Mean | Standard Deviation | percentage | 1 month |
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| Other Pre-specified | HbA1c | Posted | Mean | Standard Deviation | percentage | 3 months |
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| Other Pre-specified | HbA1c | Posted | Mean | Standard Deviation | percentage | 6 months |
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| Other Pre-specified | Mean Haptoglobin (Hp) | Posted | Mean | Standard Deviation | mg/dL | baseline |
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| Other Pre-specified | Mean Hp | Posted | Mean | Standard Deviation | mg/dL | 1 month |
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| Other Pre-specified | Mean Hp | Posted | Mean | Standard Deviation | mg/dL | 3 months |
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| Other Pre-specified | Mean Hp | Posted | Mean | Standard Deviation | mg/dL | 6 months |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | SRP Without Minocycline HCl Microspheres | The control group will not have minocycline HCl microspheres, 1 mg administered. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|