The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Minocycline HCL Microspheres

Primary Measures

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

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 65 Years

Lead Sponsor: OraPharma

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00371332

Study ID Number: OPI-145`

ClinicalTrials.gov Identifier: NCT00371332

Health Authority: United States: Food and Drug Administration

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