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

Sunstar

Status and phase: Completed; Phase 3

Conditions: Adult Periodontitis

Treatments: Drug: minocycline HCl 2.1%; Procedure: Scaling and root planing

Study type: Interventional

Funder types: Industry

Identifiers

NCT00529555

SB-PER-05-001

Details and patient eligibility

About

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.

Enrollment: 602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate to severe periodontitis

Exclusion criteria

• recent periodontal therapy
• certain medical or dental conditions
• pregnancy
• allergy to active drug or related drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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602 participants in 3 patient groups, including a placebo group

Scaling and root planing + SHAM TX

Sham Comparator group

Description:

sham treatment

Treatment:

Procedure: Scaling and root planing

Scaling and root planing + Vehicle

Placebo Comparator group

Description:

Placebo

Treatment:

Procedure: Scaling and root planing

Scaling & root planing + Periocline Gel

Active Comparator group

Description:

Minocycline HCL 2.1%

Treatment:

Drug: minocycline HCl 2.1%