CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 70 enrolled
Drug / intervention
minocycline HCl microspheresdrug
Likely dose
minocycline HCl microspheres 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03762915
NCT03762915Phase 4Completed

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

University of Minnesota·interventional·Posted Dec 4, 2018·Updated Jan 28, 2025

In Brief

A Phase 4 clinical trial evaluating minocycline HCl microspheres for SRP and 2 related conditions. Completed, enrolled 70 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 4, 2018
Enrollment StartMay 20, 2019
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.6 years ago

Interventions

minocycline HCl microspheresdrug

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.