Scaling and Root Planing (SRP) With and Without Minocycline HCl Microspheres, 1 mg

Biomarkers Clinical Trial

Official title:

Effect of Non-Surgical Periodontal Therapy With and Without Minocycline HCl Microspheres, 1 mg on Bacterial Load and Systemic Markers of Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03762915
• Other study ID #: DENT-2018-27312
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this study is to investigate the qualitative and quantitative effects of scaling and root planing (SRP) with and without minocycline HCL microspheres, 1 mg on periodontal pathogens and overall bacterial load.

A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.

Specific Aim 1: Evaluate the cumulative oral periodontal bacterial burden in both control and test groups over a six month period.

Specific Aim 2: Assess gingival crevicular fluid (GCF) and serum biomarkers of inflammation.

Description:

A randomized controlled clinical trial of a control (SRP) group and an experimental (SRP with minocycline HCl microspheres, 1 mg) group is planned.

The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit. Saliva samples, GCF, and blood serum will be collected at four time points (baseline, 1, 3, and 6 month follow up). Saliva will be analyzed for overall pathogen burden. GCF will be analyzed for Interleukin (IL)-1, IL-6, and tumor necrosis factor alpha (TNF-α). Serum will be analyzed for C-reactive protein (hsCRP), haptoglobin (Hp), hemoglobin A1c (Hgb A1c), IL-1, IL-6, and TNF-α.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and Female

• At least 18 years of age

• ADA Class III-IV Chronic Periodontitis

• Scaling and Root Planing (SRP) or localized SRP

• A minimum of eight sites with pockets =5mm with bleeding on probing (any quadrant)

Exclusion Criteria:

• Unable to comply with study protocol

• Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months

• 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.)

• Tetracycline allergy

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

Related Conditions & MeSH terms

• Biomarkers
• Minocycline HCl Microspheres
• SRP

Intervention

Drug:
• minocycline HCl microspheres
Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Bausch Health Companies, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gingival Crevicular Fluid (GCF) Markers	mean	baseline, 1, 3, and 6 months
Other	Serum Markers	mean C-Reactive Protein (CRP)	baseline
Other	Serum Markers	mean CRP	1 month
Other	Serum Markers	mean CRP	3 months
Other	Serum Markers	mean CRP	6 months
Other	Glycated Hemoglobin (HbA1c)		baseline
Other	HbA1c		1 month
Other	HbA1c		3 months
Other	HbA1c		6 months
Other	Mean Haptoglobin (Hp)		baseline
Other	Mean Hp		1 month
Other	Mean Hp		3 months
Other	Mean Hp		6 months
Primary	Bacteria Load (log10)	This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.; For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).	Baseline
Primary	Bacteria Load (log10)	This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.; For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).	3 months
Primary	Bacteria Load (log10)	This is log 10 of the Bacteria load measured. The lower amount of bacteria means good conditions and the higher amount of bacteria means worse conditions.; For data analysis fixed effects terms for log10 pathogen quantity were summarized using estimated marginal means with 95% confidence intervals (CI).	6 months