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Completed

NCT Number: NCT00668746

Long-term Safety of Minocycline in Patients With Gum Disease

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.

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Key information

Conditions

Periodontitis Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Forsyth Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

minocycline HCl microspheres

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.

Other names: minocycline

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

OraPharma

Industry

Registry information

Official study title

Long-term Safety Evaluation of Minocycline Resistance After Treatment With Minocycline HCl Microspheres, 1 mg in Subjects With Chronic Periodontitis

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 29, 2008
Registry last updated
Dec 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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