Biomarkers, Minocycline HCl Microspheres, SRP
Conditions
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.
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.
Interventions
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.
Sponsors
Bausch Health Americas, Inc.
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteria Load (log10) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 1 month | — |
| Mean Haptoglobin (Hp) | baseline | — |
| Glycated Hemoglobin (HbA1c) | baseline | — |
| Gingival Crevicular Fluid (GCF) Markers | baseline, 1, 3, and 6 months | mean |
| Serum Markers | baseline | mean C-Reactive Protein (CRP) |
| Mean Hp | 1 month | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| SRP Without Minocycline HCl Microspheres The control group will not have minocycline HCl microspheres, 1 mg administered. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | SRP Without Minocycline HCl Microspheres | Total | SRP With Minocycline HCl Microspheres |
|---|---|---|---|
| Age, Continuous | 54.29 years STANDARD_DEVIATION 14.78 | 52.8 years STANDARD_DEVIATION 15.44 | 51.31 years STANDARD_DEVIATION 16.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 16 Participants | 35 Participants | 19 Participants |
| Sex: Female, Male Female | 16 Participants | 28 Participants | 12 Participants |
| Sex: Female, Male Male | 19 Participants | 42 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
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).
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SRP With Minocycline HCl Microspheres | Bacteria Load (log10) | -11.3 log 10 copies/mL |
| SRP Without Minocycline HCl Microspheres | Bacteria Load (log10) | -10.9 log 10 copies/mL |
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).
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SRP With Minocycline HCl Microspheres | Bacteria Load (log10) | -10.3 log 10 copies/mL |
| SRP Without Minocycline HCl Microspheres | Bacteria Load (log10) | -10.7 log 10 copies/mL |
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).
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SRP With Minocycline HCl Microspheres | Bacteria Load (log10) | -10.3 log 10 copies/mL |
| SRP Without Minocycline HCl Microspheres | Bacteria Load (log10) | -9.6 log 10 copies/mL |
Other Pre-specified
Gingival Crevicular Fluid (GCF) Markers
mean
Time frame: baseline, 1, 3, and 6 months
Population: The lab had issues with the samples and couldnt use them
Other Pre-specified
Glycated Hemoglobin (HbA1c)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Glycated Hemoglobin (HbA1c) | 5.53 percentage | Standard Deviation 0.48 |
| SRP Without Minocycline HCl Microspheres | Glycated Hemoglobin (HbA1c) | 5.62 percentage | Standard Deviation 0.98 |
Other Pre-specified
HbA1c
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | HbA1c | 5.62 percentage | Standard Deviation 0.4 |
| SRP Without Minocycline HCl Microspheres | HbA1c | 5.64 percentage | Standard Deviation 0.93 |
Other Pre-specified
HbA1c
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | HbA1c | 5.56 percentage | Standard Deviation 0.4 |
| SRP Without Minocycline HCl Microspheres | HbA1c | 5.54 percentage | Standard Deviation 0.48 |
Other Pre-specified
HbA1c
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | HbA1c | 5.59 percentage | Standard Deviation 0.43 |
| SRP Without Minocycline HCl Microspheres | HbA1c | 5.65 percentage | Standard Deviation 0.85 |
Other Pre-specified
Mean Haptoglobin (Hp)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Mean Haptoglobin (Hp) | 115 mg/dL | Standard Deviation 41 |
| SRP Without Minocycline HCl Microspheres | Mean Haptoglobin (Hp) | 115 mg/dL | Standard Deviation 48 |
Other Pre-specified
Mean Hp
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Mean Hp | 115 mg/dL | Standard Deviation 40 |
| SRP Without Minocycline HCl Microspheres | Mean Hp | 110 mg/dL | Standard Deviation 38 |
Other Pre-specified
Mean Hp
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Mean Hp | 108 mg/dL | Standard Deviation 35 |
| SRP Without Minocycline HCl Microspheres | Mean Hp | 110 mg/dL | Standard Deviation 39 |
Other Pre-specified
Mean Hp
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Mean Hp | 110 mg/dL | Standard Deviation 36 |
| SRP Without Minocycline HCl Microspheres | Mean Hp | 114 mg/dL | Standard Deviation 38 |
Other Pre-specified
Serum Markers
mean CRP
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Serum Markers | 1.87 mg/L | Standard Deviation 2.05 |
| SRP Without Minocycline HCl Microspheres | Serum Markers | 1.89 mg/L | Standard Deviation 2 |
Other Pre-specified
Serum Markers
mean CRP
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Serum Markers | 1.87 mg/L | Standard Deviation 2.66 |
| SRP Without Minocycline HCl Microspheres | Serum Markers | 2.09 mg/L | Standard Deviation 2.36 |
Other Pre-specified
Serum Markers
mean C-Reactive Protein (CRP)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Serum Markers | 2.34 mg/L | Standard Deviation 2.7 |
| SRP Without Minocycline HCl Microspheres | Serum Markers | 1.81 mg/L | Standard Deviation 1.59 |
Other Pre-specified
Serum Markers
mean CRP
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRP With Minocycline HCl Microspheres | Serum Markers | 1.79 mg/L | Standard Deviation 2.18 |
| SRP Without Minocycline HCl Microspheres | Serum Markers | 1.60 mg/L | Standard Deviation 2.1 |