NCT04312542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 21, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

March 13, 2020

Last Update Submit

September 21, 2022

Conditions

SRPMinocycline HCl MicrospheresBiomarkers

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

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

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

Interventions

Measurement of BiomarkersPROCEDURE

Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.

SRP with minocycline HCl microspheresSRP without minocycline HCl microspheres

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • \- Participated in interventional phase of the trial STUDY00004876

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Michelle B Arnett, RDH, BS, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2020

First Posted

March 18, 2020

Study Start

July 21, 2020

Primary Completion

August 16, 2022

Study Completion

August 16, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Locations

US(1)