CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 602 enrolled
Drug / intervention
minocycline HCl 2.1% +1 moredrug
Likely dose
Not stated in 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/NCT00529555
NCT00529555Phase 3Completed

A 9 Month,3-arm Multicenter Clinical Trial of Treatment With Periocline Gel (2.1% Minocycline HCl) for Adjunctive Use to Scaling and Root Planing (SRP) in Adults With Periodontal Disease.

Sunstar Americas·interventional·Posted Sep 14, 2007·Updated May 9, 2014

In Brief

A Phase 3 clinical trial evaluating minocycline HCl 2.1% and Scaling and root planing for Adult Periodontitis. Completed, enrolled 602 participants across 10 sites.

Detailed Summary

Periodontal disease (commonly called gum disease) is generally treated by deep cleaning of the root surfaces of the teeth. This is also called scaling and root planing. Placing a topical antibiotic into the periodontal pocket at the time of scaling and root planing may help reduce pocket depth and thus help the periodontal disease. Periocline (minocycline HCl) 2.1% gel is a topical antibiotic approved in a number of countries for this use, and is now being tested in the US.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.8 years ago

Interventions

minocycline HCl 2.1%drug

Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months.

Scaling and root planingprocedure

scaling and root planing