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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.
Information provided by:
OraPharma Identifier:
First received: September 1, 2006
Last updated: September 22, 2006
Last verified: September 2006
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

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

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
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Please refer to this study by its identifier: NCT00371332

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
  More Information Identifier: NCT00371332     History of Changes
Other Study ID Numbers: OPI-145`
Study First Received: September 1, 2006
Last Updated: September 22, 2006

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

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on August 23, 2017