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Long-term Safety of Minocycline in Patients With Gum Disease

NCT ID: NCT00668746

Last Updated: 2011-12-12

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

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-02-28

Brief Summary

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This study will look at the safety of using the study medicine for a long time. It will see if the germs get used to the medicine, making it not work as well, if it's used by people with gum disease for a long time.

Detailed Description

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The objective of this study is to evaluate the changes in populations of minocycline-resistant bacteria after long-term use of minocycline HCl microspheres, 1 mg in subjects with moderate-to-severe chronic periodontitis. This will be assessed through monitoring the total number and proportion of minocycline-resistant bacteria and the identity of minocycline-resistant species within a panel of 40 representative periodontal species in saliva and subgingival plaque.

Conditions

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Periodontitis

Keywords

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chronic periodontitis, antibiotic resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Minocycline HCl microspheres

Minocycline HCl microspheres

Group Type EXPERIMENTAL

Minocycline HCl microspheres

Intervention Type DRUG

At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.

No drug intervention

No drug intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Minocycline HCl microspheres

At Baseline and all interim visits, a single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) will be professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm.

Intervention Type DRUG

Other Intervention Names

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minocycline

Eligibility Criteria

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Inclusion Criteria

* generally healthy
* over 25 years of age
* moderate-to-severe chronic periodontitis
* documented informed consent
* willing to comply with contraceptive requirements
* free from any significant oral soft tissue pathology

Exclusion Criteria

* willing to adhere to prohibitions and restrictions of the study
* oral health inappropriate for study inclusion
* females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
* reporting any of the following conditions:

* allergy to a tetracycline-class drug
* systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
* active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
* diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
* participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
* employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
* anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OraPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Lynch, DMD, PhD

Role: STUDY_DIRECTOR

OraPharma

Locations

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Forsyth Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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OP-P-5756-1

Identifier Type: -

Identifier Source: org_study_id