Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
Information source: Sunstar Americas
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adult Periodontitis
Intervention: Periocline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sunstar Americas Official(s) and/or principal investigator(s):
Robert Genco, DDS, PhD, Principal Investigator, Affiliation: State University of New York at Buffalo
Overall contact:
Lindsey V Wood, PhD, Phone: 773-481-6840, Email: lindsey.wood@sunstar.com
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction in pocket depth
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- moderate to severe periodontitis
Exclusion Criteria:
- recent periodontal therapy
- certain medical or dental conditions
- pregnancy
- allergy to active drug or related drugs
Locations and Contacts
Lindsey V Wood, PhD, Phone: 773-481-6840, Email: lindsey.wood@sunstar.com
Dental Medicine, SUNY Buffalo, Buffalo, New York 14214, United States; Recruiting
Robert Genco, DDS, PhD, Phone: 716-645-3113, Email: rjgenco@buffalo.edu
Additional Information
Starting date: January 2006
Ending date: December 2008
Last updated: September 11, 2007
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