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

NCT ID: NCT04312542

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-21

Study Completion Date

2022-08-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SRP Minocycline HCl Microspheres Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Measurement of Biomarkers

Intervention Type PROCEDURE

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.

Measurement of Biomarkers

Intervention Type PROCEDURE

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

Interventions

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Measurement of Biomarkers

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle B Arnett, RDH, BS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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DENT-2020-28624

Identifier Type: -

Identifier Source: org_study_id

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