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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: July 12, 2012
Last verified: July 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Sunstar Americas:

Primary Outcome Measures:
  • Reduction in pocket depth [ Time Frame: Measured at baseline and 9 months ] [ Designated as safety issue: No ]

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)
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
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: Sunstar Americas
ClinicalTrials.gov Identifier: NCT00529555     History of Changes
Other Study ID Numbers: SB-PER-05-001
Study First Received: September 11, 2007
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013