NCT00529555

Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Sunstar Americas · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Periodontitis

Interventions

Type	Name	Description
DRUG	minocycline HCl 2.1%	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.
PROCEDURE	Scaling and root planing	scaling and root planing

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-09-14
• Last updated: 2014-05-09
• Results posted: 2014-05-09

Locations

10 sites across 1 country: United States