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

NCT ID: NCT00371332

Last Updated: 2006-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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

Detailed Description

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Conditions

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Periodontitis

Keywords

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chronic periodontitis, mouth Moderate to advanced chronic periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Minocycline HCL Microspheres

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OraPharma

INDUSTRY

Sponsor Role lead

Locations

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Los Angeles, California, United States

Site Status

Baltimore, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Buffalo, New York, United States

Site Status

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://download.veritasmedicine.com/PDF/OPI-145_CSR.pdf

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

Other Identifiers

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OPI-145'

Identifier Type: -

Identifier Source: org_study_id