Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
Information source: OraPharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Periodontitis
Intervention: Minocycline HCL Microspheres (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: OraPharma
Summary
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with
moderate to advanced periodontal disease
Clinical Details
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
Secondary outcome: Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): 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
Locations and Contacts
Los Angeles, California, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Buffalo, New York, United States
Memphis, Tennessee, United States
Additional Information
Effect of Adjunctive Treatment with Arestin on the Subgingival Microflora in Patients with Moderate to Advanced Periodontitis
Starting date: January 2004
Last updated: September 22, 2006
|
