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

This study has been completed.
Information provided by (Responsible Party):
Sunstar Americas Identifier:
First received: September 11, 2007
Last updated: July 12, 2012
Last verified: July 2012

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:
  • 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
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00529555

United States, New York
State University of New York at Buffalo, Dental Medicine
Buffalo, New York, United States, 14214
Sponsors and Collaborators
Sunstar Americas
Principal Investigator: Robert Genco, DDS, PhD State University of New York at Buffalo
  More Information

No publications provided

Responsible Party: Sunstar Americas 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:
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014