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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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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-24t799 |
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Date of registration:
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28/09/2012 |
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Primary sponsor: |
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Public title:
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Effect of cleaning teeth in the levels of c-reactive protein in the blood of patients with severe disease in teeth and bone of the maxilla and mandible
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Scientific title:
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Effect of nonsurgical periodontal therapy on levels of c-reactive protein in serum of subjects with severe periodontitis |
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Date of first enrolment:
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12/06/2011 |
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Target sample size:
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55 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-24t799/ |
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Study type:
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Study design:
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Clinical trial, non randomized, single group, opened, single arm
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Anne
Leite |
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Address:
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Rua Copaíba lote 4 Ed Sam Marino apt 103
71919-540
Águas Claras
Brazil |
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Telephone:
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+55(61)3435-8587 |
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Email:
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annecarolinaleite@gmail.com |
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Affiliation:
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Universidade de Brasília |
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Name:
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Anne
Leite |
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Address:
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Rua Copaíba lote 4 Ed Sam Marino apt 103
71919-540
Águas Claras
Brazil |
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Telephone:
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+55(61)3435-8587 |
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Email:
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annecarolinaleite@gmail.com |
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Affiliation:
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Universidade de Brasília |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects with periodontitis; Periodontitis group: 19 women, nine men; with at least 18 teeth in upper or lower dental arch; be aged a minimum of 20 and maximum of 45 years; no radiographic evidence of bone loss.
Exclusion criteria: History of smoking; pregnancy or lactation; periodontal therapy; antimicrobial therapy for systemic conditions or use of topical oral antibiotics in the last twelve months; diabetes; autoimmune disease; active acute infections; active severe allergies; active gastrointestinal diseases; active renal diseases; active cancer; morbid obesity (Body mass index -BMI- >40 kg/m2) or underweight (malnourished BMI <18.5 kg/m2); use of medications in the last twelve months that alter the levels of inflammatory mediators.
Age minimum:
20Y
Age maximum:
45Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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C-reactive protein, periodontal diseases C07.465.714.533
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Intervention(s)
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Nonsurgical periodontal therapy, ie, scaling and root planing of the dental bacterial biofilm and subgingival calculus with specific curettes. Subjects with periodontitis were treated in three stages: mechanical periodontal therapy, sites reinstrumentation, and SPT. The first stage was carried out in less than 14 days. One month later, in stage 2, new mechanical instrumentation was performed in patients who persisted with deep pockets, BOP and calculus. At this stage, meticulous scaling and root planing were performed until reaching the following periodontal conditions: PD above 4 mm in at least three or fewer sites, PD above 5 mm in two places at most, PI less than 15% and BOP less than 10%. In Stage 3, subjects were scheduled biweekly or monthly, according to the need to control biofilm formation. SPT was performed for six months. This study is characterized as clinical trial, non randomized, single group, opened, single arm. Minimum age for inclusion: 20 years. Maximum age for inclusion: 45 years.
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Primary Outcome(s)
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Primary outcomes: after periodontal therapy, it was noted a decrease in all clinical periodontal parameters and levels of C-reactive protein. The reduced levels of high-sensitivity c-reactive protein after periodontal therapy was of sufficient magnitude to provide a positive change in the risk category for cardiovascular disease. The association between improvement of clinical parameters and c-reactive protein levels in patients with severe periodontitis demonstrates the systemic effects of periodontal infection. All clinical periodontal parameters were assessed by clinical examination with a manual millimetric probe. Levels of c-reactive protein were assessed by blood samples.
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Secondary Outcome(s)
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Secondary outcomes: it was noted a significant increase in high density lipoprotein (HDL) and no significant change in other serum lipids after periodontal therapy.
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Secondary ID(s)
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0067.0.012.012-08
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045/2008
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Source(s) of Monetary Support
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Universidade de Brasília - Brasília, DF, Brazil
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