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

This study has been completed.

First Received: September 1, 2006 Last Updated: September 22, 2006 History of Changes

Sponsor:	OraPharma
Information provided by:	OraPharma
ClinicalTrials.gov Identifier:	NCT00371332

Purpose

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

Condition	Intervention	Phase
Periodontitis	Drug: Minocycline HCL Microspheres	Phase III

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

Resource links provided by NLM:

Drug Information available for: Minocycline Minocycline hydrochloride

Further study details as provided by OraPharma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	128
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371332

Locations

United States, California

Los Angeles, California, United States
United States, Maryland

Baltimore, Maryland, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, New York

Buffalo, New York, United States
United States, Tennessee

Memphis, Tennessee, United States

Sponsors and Collaborators

OraPharma

More Information

Additional Information:

No publications provided

Study ID Numbers:	OPI-145`
Study First Received:	September 1, 2006
Last Updated:	September 22, 2006
ClinicalTrials.gov Identifier:	NCT00371332 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by OraPharma:

chronic periodontitis, mouth
Moderate to advanced chronic periodontitis

Additional relevant MeSH terms:

Mouth Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Minocycline
Periodontal Diseases

Periodontitis
Therapeutic Uses
Stomatognathic Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010