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

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ClinicalTrials.gov Identifier: NCT00529555
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):
Sunstar Americas

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.

Condition or disease Intervention/treatment Phase
Adult Periodontitis Drug: minocycline HCl 2.1% Procedure: Scaling and root planing Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : January 2006
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Scaling and root planing + SHAM TX
sham treatment
Procedure: Scaling and root planing
scaling and root planing
Other Name: SRP
Placebo Comparator: Scaling and root planing + Vehicle
Procedure: Scaling and root planing
scaling and root planing
Other Name: SRP
Active Comparator: Scaling & root planing + Periocline Gel
Minocycline HCL 2.1%
Drug: minocycline HCl 2.1%
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.
Other Name: periocline

Primary Outcome Measures :
  1. Change in Pocket Depth. [ Time Frame: baseline & 9 months ]
    Average change of Pocket Depth at 9 months from baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • moderate to severe periodontitis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529555

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California - San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida
Gainsville, Florida, United States, 32610
United States, Maryland
University of Maryland - Dental School
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston University Dental School
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan Oral Health Research Center
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
State University of New York at Buffalo, Dental Medicine
Buffalo, New York, United States, 14214
United States, Pennsylvania
University of Pennsylvania Dental School
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Sunstar Americas
Principal Investigator: Robert Genco, DDS, PhD State University of New York at Buffalo

Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT00529555     History of Changes
Other Study ID Numbers: SB-PER-05-001
First Posted: September 14, 2007    Key Record Dates
Results First Posted: May 9, 2014
Last Update Posted: May 9, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents