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

This study has been completed.
Sponsor:
Information provided by:
OraPharma
ClinicalTrials.gov Identifier:
NCT00371332
First received: September 1, 2006
Last updated: September 22, 2006
Last verified: September 2006
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00371332     History of Changes
Other Study ID Numbers: OPI-145`
Study First Received: September 1, 2006
Last Updated: September 22, 2006
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014