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...
Brief Summary
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Minocycline HCL Microspheres
Outcome Measures for this Clinical Trial
Primary Measures
- The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days.
Secondary Measures
- Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 65 Years
Clinical Trial Investigator Information
Lead Investigator: OraPharma Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00371332
Study ID Number: OPI-145`
ClinicalTrials.gov Identifier: NCT00371332
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00371332
