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Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00371332
First Posted: September 4, 2006
Last Update Posted: September 25, 2006
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:
OraPharma
  Purpose
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease

Condition Intervention Phase
Periodontitis Drug: Minocycline HCL Microspheres Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by OraPharma:

Primary Outcome Measures:
  • The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.

Secondary Outcome Measures:
  • Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing

Estimated Enrollment: 128
Study Start Date: January 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Generalized moderate to advanced chronic periodontitis, five sites with probing depths of >5 mm in 5 non-adjacent interproximal spaces, excluding the distal of terminal teeth, at least 16 teeth excluding 3rd molars and implants

Exclusion Criteria:

  • Allergy to tetracycline
  • Subjects with aggressive periodontitis
  • Acute necrotizing ulcerative gingivitis, or gross decay
  • Systemic conditions which could influence the course of periodontal disease (i.e, diabetes, autoimmune disease, etc)
  • Individuals requiring prophylactic antibiotics
  • Any periodontal therapy within the previous 3 months (excluding maintenance therapy)
  • Systemic or local antibiotic therapy within three months
  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): NCT00371332


Locations
United States, California
Los Angeles, California, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
Buffalo, New York, United States
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
OraPharma
  More Information

ClinicalTrials.gov Identifier: NCT00371332     History of Changes
Other Study ID Numbers: OPI-145`
First Submitted: September 1, 2006
First Posted: September 4, 2006
Last Update Posted: September 25, 2006
Last Verified: September 2006

Keywords provided by OraPharma:
chronic periodontitis, mouth
Moderate to advanced chronic periodontitis

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