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Long-term Safety of Minocycline in Patients With Gum Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668746
First Posted: April 29, 2008
Last Update Posted: December 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OraPharma
  Purpose
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.

Condition Intervention Phase
Periodontitis Drug: Minocycline HCl microspheres Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

Resource links provided by NLM:


Further study details as provided by OraPharma:

Primary Outcome Measures:
  • Change in Percent of Minocycline-Resistant Bacteria Using Bacterial Culture [ Time Frame: from Baseline to Day 30 and Day 180 ]
    Percentage Change from Baseline is calculated as post-baseline percent minus baseline percent.


Secondary Outcome Measures:
  • Micocycline-Resistance From Plaque Samples [ Time Frame: Baseline, Day 30 and Day 180 ]
    Percentage of Subjects showing Micocycline-Resistance for each Species from Plaque Samples DNA Method: Plaque Sample Intent-to-Treat Subjects - we report average of percentage for 4 plaque samples

  • Micocycline-Resistance From Saliva Sample [ Time Frame: Baseline, Day 30 and Day 180 ]
    Percentage of Subjects Showing Micocycline-Resistance for each Species from Saliva Sample DNA Method: Saliva Sample Intent-to-treat Subjects


Enrollment: 35
Study Start Date: December 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline HCl microspheres
Minocycline HCl microspheres
Drug: 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.
Other Name: minocycline
No Intervention: No drug intervention
No drug intervention

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668746


Locations
United States, Massachusetts
Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
OraPharma
Investigators
Study Director: Michael Lynch, DMD, PhD OraPharma
  More Information

Responsible Party: OraPharma
ClinicalTrials.gov Identifier: NCT00668746     History of Changes
Other Study ID Numbers: OP-P-5756-1
First Submitted: April 24, 2008
First Posted: April 29, 2008
Results First Submitted: February 26, 2010
Results First Posted: March 16, 2010
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by OraPharma:
chronic periodontitis, antibiotic resistance

Additional relevant MeSH terms:
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents