Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary goal of this study is to determine the amount of three systemic markers of inflammation: 1) Hemoglobin A1c (Hgb A1c, 2) High Sensitivity C-Reactive Protein (hsCRP), and 3) Haptoglobin (Hp) at 9 and 12 month follow-up post scaling and rootplaning (SRP) with and without minocycline HCl microspheres, 1 mg.
Participants from a randomized controlled clinical trial approved by the University of Minnesota (UMN) Institutional Review Board (IRB) STUDY00004876 and registered on ClinicalTrials.gov (NCT03762915) identifying the effects of SRP with and without minocycline HCl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP with minocycline HCl microspheres | Participants in this cohort received the intervention of minocycline HCl microspheres, 1 mg in the interventional phase of the trial. |
| |
| SRP without minocycline HCl microspheres | Participants in this cohort did not have minocycline HCl microspheres, 1 mg administered during the interventional phase of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of Biomarkers | Procedure | Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Hemoglobin A1C Concentration | Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes). | 9 months |
| Serum Hemoglobin A1C Concentration | Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes). | 12 months |
| Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration | Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l. | 9 months |
| Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration | Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l. | 12 months |
| Serum Haptoglobin Concentration | Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl. | 9 months |
| Serum Haptoglobin Concentration | Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl. | 12 months |
Not provided
Not provided
Inclusion Criteria:
- Participated in interventional phase of the trial STUDY00004876
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants from a randomized controlled clinical trial approved by the University of Minnesota (UMN) Institutional Review Board (IRB) STUDY00004876 and registered on ClinicalTrials.gov (NCT03762915) identifying the effects of SRP with and without minocycline HCl microspheres, 1 mg on periodontal pathogens and systemic inflammatory markers in the blood serum will be invited to participate in this 9 and 12 month follow-up study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michelle B Arnett, RDH, BS, MS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Not provided
Not provided
Not provided
Not provided