Back to resultsPeriocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
Primary Purpose
Adult Periodontitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
minocycline HCl 2.1%
Scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Adult Periodontitis
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- University of California - San Francisco
- University of Florida
- University of Maryland - Dental School
- Boston University Dental School
- University of Michigan Oral Health Research Center
- University of Minnesota
- State University of New York at Buffalo, Dental Medicine
- University of Pennsylvania Dental School
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Placebo Comparator
Active Comparator
Arm Label
Scaling and root planing + SHAM TX
Scaling and root planing + Vehicle
Scaling & root planing + Periocline Gel
Arm Description
sham treatment
Placebo
Minocycline HCL 2.1%
Outcomes
Primary Outcome Measures
Change in Pocket Depth.
Average change of Pocket Depth at 9 months from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00529555
Brief Title
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
602 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scaling and root planing + SHAM TX
Arm Type
Sham Comparator
Arm Description
sham treatment
Arm Title
Scaling and root planing + Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Scaling & root planing + Periocline Gel
Arm Type
Active Comparator
Arm Description
Minocycline HCL 2.1%
Intervention Type
Drug
Intervention Name(s)
minocycline HCl 2.1%
Other Intervention Name(s)
periocline
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Other Intervention Name(s)
SRP
Intervention Description
scaling and root planing
Primary Outcome Measure Information:
Title
Change in Pocket Depth.
Description
Average change of Pocket Depth at 9 months from baseline
Time Frame
baseline & 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Genco, DDS, PhD
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Florida
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Maryland - Dental School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston University Dental School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Michigan Oral Health Research Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
State University of New York at Buffalo, Dental Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
University of Pennsylvania Dental School
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis
We'll reach out to this number within 24 hrs