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

Phase 3

Completed

• Conditions: Periodontitis

• Registration Number: NCT00371332
• Lead Sponsor: OraPharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Status Verified: 2006-09
• Study First Submitted: 2006-09-01
• Study First Submitted QC: 2006-09-01
• Study First Posted: 2006-09-04
• Last Update Submitted: 2006-09-22
• Last Update Posted: 2006-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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