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

NCT ID: NCT00529555

Last Updated: 2014-05-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adult Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Scaling and root planing + SHAM TX

sham treatment

Group Type SHAM_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

scaling and root planing

Scaling and root planing + Vehicle

Placebo

Group Type PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

scaling and root planing

Scaling & root planing + Periocline Gel

Minocycline HCL 2.1%

Group Type ACTIVE_COMPARATOR

minocycline HCl 2.1%

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Scaling and root planing

scaling and root planing

Intervention Type PROCEDURE

Other Intervention Names

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periocline SRP

Eligibility Criteria

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Inclusion Criteria

* moderate to severe periodontitis

Exclusion Criteria

* recent periodontal therapy
* certain medical or dental conditions
* pregnancy
* allergy to active drug or related drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunstar Americas

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Genco, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of California - San Francisco

San Francisco, California, United States

Site Status

University of Florida

Gainsville, Florida, United States

Site Status

University of Maryland - Dental School

Baltimore, Maryland, United States

Site Status

Boston University Dental School

Boston, Massachusetts, United States

Site Status

University of Michigan Oral Health Research Center

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

State University of New York at Buffalo, Dental Medicine

Buffalo, New York, United States

Site Status

University of Pennsylvania Dental School

Philadelphia, Pennsylvania, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SB-PER-05-001

Identifier Type: -

Identifier Source: org_study_id

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