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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunstar Americas
ClinicalTrials.gov Identifier:
NCT00529555
First received: September 11, 2007
Last updated: April 10, 2014
Last verified: April 2014
  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: minocycline HCl 2.1%
Procedure: Scaling and root planing
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.

Resource links provided by NLM:


Further study details as provided by Sunstar Americas:

Primary Outcome Measures:
  • Change in Pocket Depth. [ Time Frame: baseline & 9 months ] [ Designated as safety issue: No ]
    Average change of Pocket Depth at 9 months from baseline


Enrollment: 602
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Robert Genco, DDS, PhD State University of New York at Buffalo
  More Information

No publications provided

Responsible Party: Sunstar Americas
ClinicalTrials.gov Identifier: NCT00529555     History of Changes
Other Study ID Numbers: SB-PER-05-001
Study First Received: September 11, 2007
Results First Received: July 10, 2013
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Periodontitis
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014