Conditions: Adult Periodontitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 602
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: sham treatment arm 2: Placebo arm 3: Minocycline HCL 2.1%

Interventions: intervention 1: minocycline HCl 2.1% intervention 2: Scaling and root planing
Intervention descriptions: intervention 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. intervention 2: scaling and root planing

Protocol document: