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

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

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Key information

Conditions

Periodontitis Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Los Angeles, California, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

minocycline HCl microspheres

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

OraPharma

Industry

Registry information

Important dates

Study start: 2004
First posted: Sep 4, 2006
Registry last updated: Sep 25, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed