Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis - Full Text View

Sponsor:	Sunstar Americas
Information provided by:	Sunstar Americas
ClinicalTrials.gov Identifier:	NCT00529555

Purpose

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.

Condition	Intervention	Phase
Adult Periodontitis	Drug: Periocline	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Further study details as provided by Sunstar Americas:

Primary Outcome Measures:

Reduction in pocket depth [ Time Frame: Measured at baseline and 9 months ]

Enrollment:	600
Study Start Date:	January 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529555

Locations

United States, New York
State University of New York at Buffalo, Dental Medicine
Buffalo, New York, United States, 14214

Sponsors and Collaborators

Sunstar Americas

Investigators

Principal Investigator:

Robert Genco, DDS, PhD

State University of New York at Buffalo

More Information

No publications provided

Responsible Party:	Gary Magistrelli, PhD, Sr. Manager Regulatory & Clinical Affairs, Sunstar Americas, Inc.
ClinicalTrials.gov Identifier:	NCT00529555 History of Changes
Other Study ID Numbers:	SB-PER-05-001
Study First Received:	September 11, 2007
Last Updated:	January 27, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 24, 2012