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

• Sponsor: University of Minnesota (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04312542
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 29.3
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
SRP; Minocycline HCl Microspheres; Biomarkers	Procedure: Measurement of Biomarkers

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Systemic Markers of Inflammation: 9- and 12-Month Follow-Up Post Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1mg
• Actual Study Start Date: Jul 21, 2020
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: Measurement of Biomarkers; Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.
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.	Procedure: Measurement of Biomarkers; Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.

Outcome Measures

Primary Outcome Measures

1. Serum Hemoglobin A1C Concentration [9 months]

   Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes).

2. Serum Hemoglobin A1C Concentration [12 months]

   Serum hemoglobin A1C (hbA1c) concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in standard clinical units (percent glycolated erythrocytes).

3. Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration [9 months]

   Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l.

4. Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration [12 months]

   Serum high sensitivity CRP concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/l.

5. Serum Haptoglobin Concentration [9 months]

   Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.

6. Serum Haptoglobin Concentration [12 months]

   Serum haptoglobin concentration will be measured using enzyme-linked immunosorbant assay (ELISA) and reported in units of mg/dl.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Michelle B Arnett, RDH, BS, MS, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04312542
• Other Study ID Numbers: DENT-2020-28624
• First Posted: Mar 18, 2020
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Inflammation

Study Results

No Results Posted as of Jan 24, 2022