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...
Date First Received: September 11, 2007
Last Updated: September 11, 2007
Verified by: Sunstar Americas, September 2007
Clinical Trial Phase: Phase 3 | Start Date: January 2006
Overall Status: Recruiting
Estimated Enrollment: 850
Brief Summary
Official Title: “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.”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Periocline
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- Reduction in pocket depth
- Time Frame: Measured at baseline and 9 months
- Time Frame: Measured at baseline and 9 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- moderate to severe periodontitis
Exclusion Criteria:
- recent periodontal therapy
- certain medical or dental conditions
- pregnancy
- allergy to active drug or related drugs
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sunstar Americas
Overall Clinical Trial Officials and Contacts
Robert Genco, DDS, PhD Principal Investigator State University of New York at Buffalo
Overall Contact: Lindsey V Wood, PhD 773-481-6840 lindsey.wood@sunstar.com
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00529555
Study ID Number: SB-PER-05-001
ClinicalTrials.gov Identifier: NCT00529555
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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