Status:

COMPLETED

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

Lead Sponsor:

OraPharma

Conditions:

Periodontitis

Eligibility:

All Genders

30-65 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2004

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

128 Patients enrolled

Trial Details

Trial ID

NCT00371332

Start Date

January 1 2004

Last Update

September 25 2006

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Los Angeles, California, United States

2

Baltimore, Maryland, United States

3

Boston, Massachusetts, United States

4

Buffalo, New York, United States