Periodontitis Clinical Trial
Verified date | September 2006 |
Source | OraPharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease
Status | Completed |
Enrollment | 128 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 30 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
OraPharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in the mean sum of primary pathogens (P. gingivalis, To forsythensis, and T. denticola) from baseline to 30 days. | |||
Secondary | Changes in the numbers of each of the primary pathogens, changes in pocket depth, attachment level, and proportion of sites bleeding on probing |
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