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

April 10, 2014 updated by: Sunstar Americas

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

602

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
    • Florida
      • Gainsville, Florida, United States, 32610
        • University of Florida
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland - Dental School
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Dental School
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan Oral Health Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Buffalo, New York, United States, 14214
        • State University of New York at Buffalo, Dental Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Dental School
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Scaling and root planing + SHAM TX
sham treatment
Procedure: Scaling and root planing
scaling and root planing
Other Names:
  • SRP
Placebo Comparator: Scaling and root planing + Vehicle
Placebo
Procedure: Scaling and root planing
scaling and root planing
Other Names:
  • 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 Names:
  • periocline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pocket Depth.
Time Frame: baseline & 9 months
Average change of Pocket Depth at 9 months from baseline
baseline & 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunstar Americas

Investigators

  • Principal Investigator: Robert Genco, DDS, PhD, State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-PER-05-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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