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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01433744 |
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Date of registration:
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12/09/2011 |
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Primary sponsor: |
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Public title:
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Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
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Scientific title:
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Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01433744 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients should have = 20 teeth present; (ii) absence of oral soft tissue lesions; (iii)
have = 3 carious lesions in all teeth. In addition, to be included in the Test group the
subject had to present chronic periodontitis (involvement of at least 5 teeth with at
least one site presenting probing depth (PD) = 5 mm and clinical attachment loss (CAL) = 3
mm) while to be included in the Control group the patient had to exhibit periodontal
healthy (bleeding on probing (BOP) < 30% of the sites and absence of any PD > 4mm
associated with BOP).
Exclusion Criteria:
(i) periodontal disease treatment in the previous six months; (ii) aged less than 35
years; (iii) systemic conditions such as history of CVD or any other chronic or
immunologic diseases and the use of related drugs in the previous six months; (iv) smokers
or former smokers; (v) pregnant or lactating women; (vi) hypertension (>140 systolic and >
90 diastolic mmHg); (vii) obesity (Body Mass Index (BMI) = 30 kg/m²); (viii) levels of
HDL-cholesterol > 35.0 mg/dL (ix) levels of LDL-cholesterol < 160.0 mg/dL (x)levels of
triglycerides < 400.0 mg/dL and (xi) levels of glucose levels < 100 mg/dL.
Age minimum:
35 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atherosclerotic Cardiovascular Disease
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Chronic Periodontitis
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Intervention(s)
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Procedure: Non-surgical periodontal treatment
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Primary Outcome(s)
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C-Reactive Protein levels
[Time Frame: Baseline and 60 days after treatment]
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Secondary Outcome(s)
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The effect of non-surgical periodontal treatment on patients with chronic periodontitis
[Time Frame: Baseline and re-evaluation 60 days after the end of treatment]
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Secondary ID(s)
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5209/2009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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