Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy

Biomarkers Clinical Trial

Official title:

Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312542
• Other study ID #: DENT-2020-28624
• Status: Completed
• Start date: July 21, 2020
• Est. completion date: August 16, 2022

Study information

• Verified date: September 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participated in interventional phase of the trial STUDY00004876

Exclusion Criteria:

• Unable to comply with study protocol

• 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.)

• Any medication that may impact periodontal conditions (Phenytoin, calciumantagonists, cyclosporin, warfarin, or NSAIDS)

Related Conditions & MeSH terms

• Biomarkers
• Inflammation
• Minocycline HCl Microspheres
• SRP

Intervention

Procedure:
• Measurement of Biomarkers
Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Serum Haptoglobin Concentration	Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.	9 months
Primary	Serum Haptoglobin Concentration	Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.	12 months