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

Adult Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529555
• Other study ID #: SB-PER-05-001
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2007
• Last updated: April 10, 2014
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: April 2014
• Source: Sunstar Americas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• moderate to severe periodontitis

Exclusion Criteria:

• recent periodontal therapy

• certain medical or dental conditions

• pregnancy

• allergy to active drug or related drugs

Study Design

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

Related Conditions & MeSH terms

• Adult Periodontitis
• Chronic Periodontitis
• Periodontitis

Intervention

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.

Procedure:
• Scaling and root planing
scaling and root planing

Locations

Country	Name	City	State
United States	University of Michigan Oral Health Research Center	Ann Arbor	Michigan
United States	University of Maryland - Dental School	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University Dental School	Boston	Massachusetts
United States	State University of New York at Buffalo, Dental Medicine	Buffalo	New York
United States	University of Florida	Gainsville	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Pennsylvania Dental School	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California - San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Sunstar Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pocket Depth.	Average change of Pocket Depth at 9 months from baseline	baseline & 9 months	No