Back to resultsEffect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Minocycline HCL Microspheres
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring chronic periodontitis, mouth, Moderate to advanced chronic periodontitis
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00371332
Brief Title
Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
OraPharma
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
chronic periodontitis, mouth, Moderate to advanced chronic periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
128 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Minocycline HCL Microspheres
Primary Outcome Measure Information:
Title
The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
Secondary Outcome Measure Information:
Title
Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Eligibility 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
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Links:
URL
http://download.veritasmedicine.com/PDF/OPI-145_CSR.pdf
Description
Effect of Adjunctive Treatment with Arestin on the Subgingival Microflora in Patients with Moderate to Advanced Periodontitis
Learn more about this trial
Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis
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